According to the NHS England, personalised medicine (otherwise known as precision medicine) is a move away from a ‘one size fits all’ approach to the treatment and care of patients with a particular condition, to “one which uses new approaches to better manage patients’ health and targets therapies to achieve the best outcomes in the management of a patient’s disease or predisposition to disease.” Other definitions, such as that from the US National Cancer Institue (NCI), define it as a form of medicine that uses information about a person’s genes, proteins, and environment to prevent, diagnose, and treat disease. Whatever the definition, one thing is clear; scientific developments are critical for the advancement of personalised therapeutics and diagnostics.

While personalised medicine has been around for centuries (George Church collaborated with Harvard professor and Nobelist Walter Gilbert to develop the first direct genome sequencing method in 1984), it is the many recent advances happening in our medical laboratories – from molecular diagnostics to DNA sequencing and companion diagnostics – that has made it possible for the medical world to deliver truly individualised patient care at a lower cost.

The real breakthrough in personalised medicine came in 2003 with the completion of the The Human Genome Project (HGP), an international research effort to sequence and map all of the genes, which, according to the National Human Genome Research Institute (NHGRI), gave us the ability, for the first time, to read nature's complete genetic blueprint for building a human being. Accordingly, the NHGRI’s definition of personalised medicine maintains that a personalised approach to medicine includes an “individual’s genetic profile to guide decisions made in regard to the prevention, diagnosis and treatment of disease.”

Since the completion of HGP, the role of genetics has played an enormous role in personalised medicine, allowing for the creation of a more unified treatment approach specific to the individual and their genome.

While the US and Europe are ahead of the game in the development, implementation and use of molecular diagnostics in personalised medicine, the medical laboratory community in the Middle East also now has access to the latest research and insights into the evolving sector. Delegates at the MEDLAB Exhibition and Congress, the world’s leading event for laboratory management and diagnostics, which took place earlier this year at the Dubai International Convention and Exhibition Centre, heard from Dr PK Menon who is the director of laboratory services at GMC Diagnostics in Ajman, UAE, about the immense potential of 4^th generation DNA sequencing to cure genetically inherited diseases, among others.

The ability to take genomics, an area within genetics that concerns the sequencing and analysis of an organism's genome, from the laboratory bench in hi-tech labs literally to the patient’s bedside will play a very important role in the future of the health of patients across the region.

According to Dr Menon, this new disruptive technology will, in the next couple of years, change how we understand genes and enable us to actually take genomics from the laboratory to the patient’s bedside for a more personalised approach.

“Our genes decide what a person is going to be like, what metabolic diseases they could suffer from and the possible cancers which may develop if the individual does not lead a healthy life,” he explained during the Congress. “DNA-based testing is gaining importance in the region and, in the times to come, more and more individuals will use DNA sequencing as a tool in precision medicine to guide themselves into predictive positive health.”

While the UAE has many labs that carry out 1^st and 2^nd generation sequencing, generating massive amounts of data over a longer period of time, the Centre for Biomedical Research and Innovation at the Gulf Medical University in Ajman has acquired the first 4^th generation sequencer in the region where they are hoping to innovate and bring in newer diagnostic capabilities allowing patients to get their results much faster.

In keeping with the idea personalising our approach to medicine in the region, the overall theme of the recent MEDLAB Congress centred around bridging the gap between clinicians and laboratory workers in all areas of healthcare.

According to Simon Page, the Managing Director of Informa Life Sciences Exhibitions, the organisers of the global series of MEDLAB events, “The relationship between the laboratory and the clinician has become increasingly important as countries in the region continue to adopt a patient-centric approach to healthcare. Each step in the process is critically important and, for the implementation of personalised medicine, all parties included should work together to deliver a more holistic approach.”

Another critical area of personalised medicine is pharmacogenetics. According to the US National Library of Medicine (NLM), this relatively new field combines pharmacology (the science of drugs) and genomics to develop effective, safe medications and doses that will be tailored to a person’s genetic makeup.

While the field of pharmacogenomics is still in its infancy and its use is currently quite limited, the NLM believes that in the future, pharmacogenomics will allow the development of tailored drugs to treat a wide range of health problems, including cardiovascular disease, Alzheimer’s disease, cancer, HIV/AIDS, and asthma.

Recent advances in companion diagnostics - tests that help determine whether a patient should receive a particular drug therapy or how much of the drug to give - are proving to be a useful tool to improve pharmacotherapy.

According to the US Food & Drug Administration (FDA), a companion diagnostic device can be an in-vitro diagnostic device or an imaging tool that provides information that is essential for the safe and effective use of a corresponding therapeutic product. While in the US, the development of both products requires close collaboration between experts in both FDA’s device centre and FDA’s drug centre for approvals, in Europe, diagnostic tests are not regulated or approved; rather, marketing of test requires that the sponsor obtain a “CE” Marking (Conformité Européene) indicating that the product had been assessed and meets European Union (EU) safety, health, and environmental protection requirements.

The best-known examples of FDA-defined companion diagnostics come from the field of oncology, however, other therapeutic areas are beginning to emerge, including cystic fibrosis, human immunodeficiency virus (HIV), and severe growth failure.

According to a recent report by Market Data Forecast, the Middle East and Africa companion diagnostics market was worth $0.37 billion in 2016 and estimated to be growing at a CAGR of 21.19%, to reach $0.96 billion by 2021. The report sites next-generation sequencing-based companion diagnostics as one of the major factors that will drive the market while regulatory uncertainty and cost allied with developing drugs are expected to impede market growth in the region.

While the promise of personalised medicine offers tangible, exciting possibilities and is practised more widely, a number of ethical, economic and practical challenges arise, particularly with it’s implementation and moral and cultural acceptance. There is the issue of what to do with all the masses of genetic data generated by the next-generation sequencing, as well as the question of cost and who should pay for the testing and the issue of patient privacy and confidentiality.

Regulatory bodies will be required to implement significant changes in order to accommodate the changing landscape as molecularly-targeted personalised medicine goes into the next phase and labs become critical in adding value to the sector. However, the responsibility for promoting this also firmly lies with the pharmaceutical industry, the laboratories, the clinicians and the patients themselves.

Without interdisciplinary cooperation of experts from across the healthcare continuum – from the lab, to the doctor’s consultation room, the surgeon’s table, to the management of information systems in hospitals and to those who pay – there remain a number of obstacles that need to be overcome to make personalised medicine mainstream in the practice of patient care.

Early Examples of Personalised Medicine 

1907: Reuben Ottenberg reports the first known blood compatibility test for transfusion using blood typing techniques and cross-matching between donors and patients to prevent hemolytic transfusion reactions. 

1956: The genetic basis for the selective toxicity of fava beans (“favism”) and the antimalarial drug primaquine is discovered to be a deficiency in the metabolic enzyme, glucose-6-phosphate dehydrogenase (G6PD). 

1977: Cytochrome P450 2D6, a polymorphic metabolising enzyme, is identified as the culprit for causing some patients to experience an “overdose” or exaggeration of the duration and intensity of the effects of debrisoquine, a drug used for treating hypertension. 

Source: Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development, October 2013

With over 120 exhibitors on 2000 sq m of floor space and five conference tracks, the launch edition of MEDLAB Europe marks its debut on 13th September 2017 at the Fira Gran Via, Barcelona, Spain. Held over a three-day period and in line with Informa Life Science’s philosophy of ‘Exhibition with Education’, MEDLAB Europe caters to the growing demand for laboratory products, services and the latest laboratory medicine advances in the European region.

As an innovative medical laboratory exhibition and congress, MEDLAB Europe will provide an opportunity to learn about advances in science and their applications in laboratory medicine that will improve practice through improving patient outcomes. This launch edition will also offer integral opportunities for the industry to showcase the latest lab management and diagnostics technologies to a worldwide audience, to advance their skills and improve lab services in today’s highly competitive market.

Following 15 years of success in the Middle East, Asia and Africa, and now including MEDLAB Americas and MEDLAB Europe, the MEDLAB exhibition and congress is a proven success on an international scale. With year-on-year growth, the MEDLAB series of events covers all areas of laboratory management and diagnostics and provides a unique platform for the industry’s multi-level professionals to meet under one roof.

Market Overview
According to a report by MedTech Europe, the European trade association representing the medical technology industries, “The European medical laboratory industry is worth €11 billion. Driven by research and development, 95% of the industry is comprised of small and medium size enterprises and approximately €1 billion per year is reinvested”.

As a market, Europe’s medtech sector has been growing on average by 4% a year over the past six years, it adds.

With the European medical laboratory market expected to reach USD 15.5 billion by 2024, a platform such as MEDLAB presents a huge opportunity for global laboratory industry leaders, including manufacturers, dealers and distributors, to make inroads into the European market.

According to Tom Coleman, Group Exhibition Director, MEDLAB Series: “The launch of MEDLAB Europe is in line with our global expansion strategy for our MEDLAB series of events. The increasing prevalence of chronic diseases, rising geriatric population coupled with the rising awareness towards early diagnosis, has positioned the European medical laboratory market as a critical market for manufacturers, services providers, and dealers and distributers from across the globe. MEDLAB Europe will generate substantial value for our customers and partners by driving further product innovation and deeper engagement in these specific markets.”

The Exhibition
MEDLAB Europe is a highly focused medical laboratory business platform that is designed to provide an exceptional combination of networking and corporate branding opportunities and is the perfect opportunity for manufacturers and service providers to boost their company profile among the influential leaders and decision-makers in the medical laboratory industry.

The exhibition enables exhibitors to present their products and services to more than 3,000 industry professionals from across the entire medical laboratory spectrum, allowing them to maximise their business engagement opportunities over three days, under one roof.      

It will give visitors from across the world an opportunity to access cutting-edge laboratory products, next-generation technology, innovative services and world-class educational content. MEDLAB Europe attracts a wide range of visitors including dealers and distributors, medical laboratory end-users, medical manufacturers, general practitioners, hospital doctors, hospital managers, hospital nursing staff, hospital technical managers, laboratory managers, physiotherapists, medical assistants, and many more. 

The Conferences
The MEDLAB Europe Conferences will host five multi-disciplinary CME accredited conference tracks that offer unparalleled education and management solutions to help advance laboratory skills and improve laboratory services in today's competitive market.

From new methods of effective lab management to the development of techniques in detecting diseases, these conferences will cover an extensive range of topics guaranteed to educate and enlighten all.

As well as the latest in clinical diagnostics developments, the conferences will also review the expanding role of the laboratory medicine and discuss partnership between a clinician and a lab professional in providing delivery of care to every patient. Laboratory professionals will gain holistic knowledge on how to streamline working practices to reduce costs, maximise the quality and quantity of lab tests, and successfully comply with the most recent regulatory challenges in the field of laboratory medicine and diagnostics.

The 2017 programme includes the following conferences:

Point of Care Testing (POCT)
Wednesday, 13th September
Greater health awareness, and the growing prevalence of lifestyle illnesses are driving new interest in point-of-care testing (POCT) and diagnosis. The development of accurate POC testing and its impact on new disease areas and disease management presents many challenges for healthcare providers. Regulatory aspects, validation and clinical applications must be considered when discussing the integration of POC. Academic and industry leaders will discuss these issues on the applications and success rate of POC testing platforms and disease management.

Histopathology
Wednesday, 13th September
Deeper understanding of cell biology using molecular tools and genomic data is radically changing the face of medical science. New classifications, profiling of individuals and diseases, drugs and personalised medicine are good components of this new paradigm. Pathology is the discipline that is at the centre of it all. This conference will discuss histopathological considerations and approaches in tissue handling and specimen preparation for the classification of tumours and will also review technical faults in the lab.

Lab Management
Thursday, 14th September
Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for medical laboratories. In addition to this, the trend towards the formation of large laboratory networks and mobile health practices proposes a whole new set of obstacles to overcome for successful management of the laboratory. This conference will discuss the most recent challenges and practical solutions on laboratory quality management systems for all stakeholders in health laboratory processes, from management to administration and laboratorians.

Clinical Microbiology
Friday, 15th September
This track will focus on the most current research related to the laboratory diagnosis of human infections, role of the laboratory in both the management of infectious diseases and epidemiology of infections. It will discuss the current state of knowledge in the field, as well perspectives on controversial issues. Other key topics addressed here will include Rapid Next Generation Sequencing for typing of MDR Gram Negative Bacteria and Next generation Mycobacteriology.

Haematology
Friday, 15th September
There have been several new developments in the field of haematology and oncology to manage the increase in the number of patients with blood disorders. This requires the need for educational sessions for healthcare providers involved in management of haematologic malignancies and solid tumours. This programme will feature scientific and practical issues in haematopathology and discuss development on standards, guidelines and recommendations for the haematology laboratory to address everyday quality challenges in the lab.

Moving towards consolidation, standardisation and automation in the laboratory to tackle today’s challenges and tomorrow’s complex healthcare landscape

It is a new era in healthcare around the world. With an ageing population and the prevalence of non-communicable diseases on the rise, the time has come for laboratories to keep up and shift their focus towards the future. Feeling the pressure of rising costs, restricting budgets and the need for improved efficiencies, laboratories are increasingly turning to consolidation, standardisation, and automation in their operations. For laboratories operating in the Middle East, where there is a constant race to tackle today’s challenges and meet tomorrow’s complex demands, this pressure to improve and advance operations is even more acute.

The emerging need to reduce the cancer burden in the Middle East

According to the World Health Organization, cancer is the second leading cause of death globally and was responsible for 8.8 million deaths in 2015 (http://www.who.int/mediacentre/factsheets/fs297/en/). Although the number of cancer cases and cancer-related deaths per year in the Middle East may currently be lower than the global average, the reported numbers are expected to continue to rise as cancer risk factors such as smoking, diabetes, obesity and others remain prevalent. Figures from GLOBACAN reveal that in the United Arab Emirates (UAE) alone, 2,935 cases of cancer were reported in 2012 of which 1,257 were fatal.

With the establishment of UAE Vision 2021, the National Agenda emphasises the importance of preventive medicine and seeks to reduce cancer and lifestyle-related diseases such as diabetes and cardiovascular diseases to ensure a longer, healthy life for its citizens. In addition, the Agenda aims to lessen the prevalence of smoking and increase the healthcare system’s readiness to deal with epidemics and other public health risks. The aim is that this will firmly cement the UAE’s position among the best countries in the world with regards to the quality of healthcare (https://www.vision2021.ae/en/national-priority-areas/world-class-healthcare).

The value of diagnostics for patients and providers

As the healthcare landscape continues to evolve over the years, the unwavering commitment to innovation remains vital for all stakeholders. Laboratories continue to play a central role in leading the way in innovation, illustrated by the fact that around 70% of the medical decisions are informed by laboratory results, resulting in precise diagnosis. This accuracy is critical in the global fight to reduce the cancer burden in our societies.

And while there are still many open or unanswered questions related to the biology of cancers, we are constantly gaining a deeper understanding of the complexity of this disease, and we are now better positioned to advancing therapies in our pursuit of a cancer-free world.

In this respect, the move from a ‘one-size-fits-all’ approach towards personalised healthcare in cancer treatment is a major breakthrough. Personalised medicine begins at the diagnosis stage, where, for instance, through advanced staining techniques, pathologists can better understand the characteristics of the specific disease, and therefore establish a well informed and precise diagnosis as the basis for the creation of individualised treatment plans for the patients.

According to Dr Basel Altrabulsi, who is the Chief Medical Officer at the UAE’s National Reference Laboratory (NRL), it is critical to understand more about the advancements in anatomic pathology and the regional availability of these techniques that further increase the importance of the role of in-vitro diagnostics in providing an invaluable source of information to healthcare professionals.

“The prevalence of chronic diseases continues to grow and causes a tremendous strain on the healthcare system in our region and across the globe,” says Dr Altrabulsi. “This increases the importance of having reliable and accurate tools to provide the right information from the start in order to avoid wasting the critical resources and to prevent poor patient outcomes derived from making a wrong diagnosis and prescribing the incorrect treatment.”

“For example, in the diagnosis of cancer and some infectious diseases, staining is an indispensable source of reliable information to make informed decisions,” explains Dr Altrabulsi. “Here at NRL, immunohistochemical staining (IHC), in-situ hybridization (ISH), silver in-situ hybridization (SISH), or dual stained slides, are processed simultaneously for maximum efficiency, with flexible protocols and continuous access to slides for improved throughput. With the advent of new technologies, the application of individual slide staining model enables the use of a fresh reagent for each patient’s sample, preventing tissue cross-contamination and therefore enabling a crisp and clear stain, for every test.”

NRL has validated more than 120 stains at its Anatomic Pathology Centre of Excellence in the UAE– one of the most comprehensive menu of stains in the country - including antibodies for Immunohistochemistry, Immunofluorescence and Special Stains. National Reference Laboratory is a Mubadala Company created in partnership with and managed by Laboratory Corporation of America® Holdings (LabCorp®), a world leading life sciences company, providing comprehensive clinical laboratory services. The Anatomic Pathology Center of Excellence of NRL houses one of the largest pools of pathology subspecialists in the region, and provides one of the largest menus of immunohistochemical stains in the UAE. 

Fighting cancer with science

According to the US National Institutes of Health (NIH), precision medicine is an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.

“We now understand that cancer is a heterogeneous disease,” Dr Altrabulsi says. “Therefore, causes, rates of progression and responses to treatment can be very different among individuals.”

“Ideally, we need to understand the molecular profile of individuals and then tailor medical care to fit each patient. Precision medicine can help in screening for cancer risk, identify tumour diagnosis, classification and prognosis, predict response to treatment, detect tumour recurrence and, most importantly, identify new therapeutic targets. With all these options at our disposal, it is a very exciting time for precision and preventive medicine, as the latest advancements in the diagnostics field are transforming the face of healthcare as we know it today,” adds Dr Altrabulsi.

With 253 exhibitors, 10 country pavilions, 29 exhibiting countries and 4,025 attendees – constituting a 60% increase in visitor turnout compared to the 2016 edition – the 4^th edition of the MEDLAB Asia Pacific Exhibition & Congress that concluded on 5^th April 2017 at Suntec Singapore Convention & Exhibition Centre firmly sealed its position in Asia’s laboratory calendar as the largest annual meeting for the IVD and medical laboratory industry.

Leading laboratory experts, scientists, researchers and clinicians converged at the three-day event to exchange and share their experiences and research results on all aspects of laboratory medicine and clinical research while companies showcased the latest innovations, products and cutting-edge technologies available in the IVD, medical laboratory and healthcare market.

A survey of the exhibitors at the event have revealed that a whopping 97% have admitted to being successful in meeting their overall objectives, 90% were successful in generating new enquiries for their businesses and 87% plan to exhibit again in 2018. With 68% of companies confirming rebooking to participate in 2018, the exhibition floor is certainly set to increase from the 6500 sq m area this year to accommodate the high demand for the next edition of the event.

In a short span of time, the MEDLAB Asia Pacific Exhibition has established itself as the ultimate platform to promote and launch the latest innovations and services in the world of healthcare and medical laboratory. According to Neville Calvert, Managing Director, Numedico Technologies, Adelaide, Australia, “We were able to make a great list of potential partners at the show. The Asian region is a key market for us and we not only did business at the show but gained a further understanding of the region.”

This year’s event also marked the launch of Asia Health, a healthcare trade fair, that offered everything from hospital equipment to medical disposable products, surgery instruments, diagnostic tools, equipment for emergency rooms, long-term care products, dental equipment, products for rehabilitation and orthopaedics, electro-medical devices, and much more. According to Simon Page, Managing Director, Informa Life Sciences Exhibitions, “Diminishing market access barriers for foreign investment, coupled with a boom in hospital construction and the highest growth rate in healthcare IT, has positioned the Asian healthcare market as a first-choice market for medical device manufacturers, services providers, and dealers and distributers from across the globe.”

Accounting for 60% of the world’s population, Asia is experiencing unprecedented change in the face of rapid economic growth. The rising demand for better healthcare systems and reforms is creating valuable opportunities for companies looking to invest in the healthcare industry. According to a recent report by Al Masah Capital Limited, the region’s healthcare market is projected to be worth US$134.2 billion by 2020.

It was to therefore generate substantial value for its customers and partners by driving further product innovation and deeper engagement in these specific markets that Asia Health was launched as part of Informa’s global expansion strategy into the Asia Pacific region, he added.

With a mix of laboratory and healthcare manufacturers, this year’s MEDLAB Asia Pacific & Asia Health welcomed dealers and distributors from across the region as well as representatives from hospitals, consultancies and governments who took the opportunity
to meet, do business with exhibitors and learn from all professionals within the healthcare and medical laboratory marketplace. 

The feedback received from the visitors at the 2017 edition reveal that 84% learned about new products, 74% sourced a new supplier, 82% successfully established new contacts and 94% have confirmed they will attend again next year.

Integral to the success of any MEDLAB exhibition is the wide variety of plenaries and panel discussions focused around laboratory diagnostics and its stellar line-up of local and international speakers. From new methods of effective lab management to the development of techniques in detecting diseases, the MEDLAB Asia Pacific conferences thus covered an extensive range of topics this year. Supported by The Academy of Medicine, Singapore
and accredited by Singapore Medical Council, it hosted 11 multi-disciplinary CME-accredited conferences that delved into an array of topics including laboratory management, infectious diseases, diabetes, clinical chemistry, molecular diagnostics, cardiac markers, haematology, gastrointestinal oncology, R&D, obs-gyne/women’s health and point of care testing.

The Asia Health Exhibition & Congress saw the launch of the flagship ‘Leaders in Healthcare’ conference which highlighted the issues surrounding governance in healthcare in Asia, international patient safety goals, healthcare delivery strategies and tools, public health strategies for an ageing population, implementing integrated care and the future of hospital management, among others.

The high visitor turnout and positive feedback from exhibitors, visitors and delegates this year attests to the dominance of MEDLAB Asia Pacific in Asia’s healthcare and medical laboratory industry while promising a strong future for Asia Health and its position in the healthcare market.

The next edition of MEDLAB Asia Pacific will be held from 2^nd to 4^thApril, 2018, at the Suntec Singapore Convention & Exhibition Centre.

Liver cancer in adult men is the fifth most frequently diagnosed cancer worldwide, and is the second leading cause of cancer-related death in the world. In adult women, it is the ninth most commonly diagnosed cancer. In Asia, liver cancer is the fifth most common cancer. Asian countries account for 75–80% of the roughly 650,000 Hepatocellular carcinoma (HCC) cases reported globally each year.

HCC usually shows mild or no symptoms in the early stage. Symptoms are more prominent when HCC is advanced.

Hence, in many cases, the optimal treatment window lapses even before a definitive diagnosis is made, and the 5-year survival rate is <10%.

Without an effective treatment for advanced stage of hepatic cancer, we can only hope to improve patient outcome by surveillance for high-risk population to increase early detection of HCC.

High risk patients for HCC include those with chronic hepatitis C (CH-C), chronic hepatitis B (CH-B), alcoholic and non-alcoholic fatty liver diseases, and other types of chronic inflammation of the liver.

Surveillance of HCC is important for early detection. Imaging tests including computed tomography, magnetic resonance imaging and ultrasonography, with or without various kinds of contrast medium are important options for detecting HCC. In addition to the imaging tests, various kinds of biomarkers including alpha-fetoprotein (AFP), and protein induced by vitamin K absence or antagonist II (PIVKA-II) have been widely used for surveillance to detect HCC and monitor treatment response.

PIVKA-II was discovered in 1984 by Liebman et al. PIVKA-II, also known as des-gamma-carboxyprothorombin (DCP), is an abnormal prothrombin precursor produced by Hepatocellular carcinoma cells, and is characterised by the incomplete or lack of carboxylated glutamic acid (Gla) residues found in normal prothrombin.

PIVKA-II has been an accepted biomarker for HCC surveillance and is currently included in evidence based Japanese and Asia Pacific Association for the Study of Liver (APASL) clinical guidelines. A US study reported a sensitivity and specificity of 89% and 95%, for differentiating patients with HCC from those with cirrhosis and chronic hepatitis.

In a French cohort, a case-control study was conducted to compare the performances of a-fetoprotein (AFP) and PIVKA-II serum levels for diagnosis of early stage HCC. For the diagnosis of early HCC, PIVKA-II had a sensitivity of 77% and a specificity of 82% at a cut-off of 42 mAU/ml, vs. 61% and 50% for AFP at a cut-off of 5.5 ng/ml (AUC 0.81 vs. 0.58, respectively).

As AFP and PIVKA-II are produced independently, these two markers serve as complementary markers for HCC. The combined use of AFP and PIVKA-II have demonstrated increased sensitivity and specificity than using either marker alone. As such, the APASL guidelines have recommended for PIVKA-II and AFP to be used together as simultaneous measurements of the two markers provides higher sensitivity without decreasing specificity.

The optimal interval of diagnostic tests in a surveillance programme should be determined based on cost-effectiveness as more frequent tests can detect HCC nodules of smaller size. Many studies have adopted an interval of six months between periodic diagnostic tests.

Current recommendations from the Japanese Society of Hepatology states that for patients with hepatitis B, hepatitis C, or cirrhosis , it is recommended that AFP, AFP-L3 fractions and PIVKA- II be measured once every six months. For the chronic hepatitis patients with cirrhosis, it is suggested that AFP, AFP-L3 fractions and PIVKA II be measured every 3-4 months.

With surveillance algorithms and the availability of PIVKA-II available in Asia Pacific, we are hopeful that HCC can be detected and treated earlier for better patient outcome.

Autoantibody testing is a cornerstone in the diagnosis of the rare autoimmune disease systemic sclerosis (SSc). SSc is characterised by a heterogeneous group of autoantibodies directed against various antigenic targets. Some of the antibodies occur frequently, while others are very rare. A large proportion of sera from SSc patients show an isolated reaction with just one antigen. Therefore, comprehensive multiparametric analysis of different autoantibodies is essential to minimise diagnostic gaps and increase the serological detection rate for SSc. As different autoantibodies are associated with different organ manifestations, autoantibody detection can also aid prognosis.

Systemic sclerosis

SSc, also known as scleroderma, is an autoimmune connective tissue disease which occurs mainly in middle adulthood. Approximately 2 to 50 out of 100,000 people suffer from SSc worldwide. Early symptoms of SSc are shortening of the lingual frenum and Raynaud’s syndrome, followed by oedema of the hands and feet. The skin becomes stiff, atropic, waxy and thin. The hands become deformed (claw hand) with highly tapered finger ends (Madonna fingers), and the face becomes rigid and mask-like. In later stages, callosity of the inner organs, particularly the digestive tract, lungs, heart and kidneys occurs.

SSc is divided into different subsets. In limited cutaneous SSc, skin involvement is limited to the distal extremities. In the diffuse cutaneous SSc, the symptoms are diffusely distributed over the trunk, the proximal extremities and the face. A third subset without skin involvement is also known. The so-called CREST syndrome of SSc manifests with calcinosis, Raynaud’s syndrome, esophageal dysfunction, sclerodactyly (thin, pale, thickened and hairless skin on the fingers) and teleangiectasis (persistent pathological dilation of superficial skin vessels).

Diagnosis of SSc is made according to criteria established by the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR). However, clinical diagnosis can be difficult, especially in the early stages and in patients with the limited form of the disease. Currently known specific autoantibodies can be found in over 95% of patients with SSc. Autoantibody diagnostics facilitate early diagnosis of SSc and its differentiation from other collagenoses such as systemic lupus erythematosus, polymyositis, Sharp syndrome and Sjögren’s syndrome. The autoantibody specificities also provide an indication of the SSc subtype and serve as a tool for disease monitoring and prognosis.

Autoantibodies in SSc

Autoantibodies in SSc are directed predominantly against components of the cell nucleus. The target antigens include DNA topoisomerase 1 (Scl-70), centromere proteins (CENP A and B), RNA polymerase III (Rp 11 and RP155), PM-Scl complex proteins (PM-Scl100 and PM-Scl75), fibrillarin, as well as the rarer target antigens NOR (nucleolus organising region) 90, Th/To and Ku.

Different autoantibody specificities are associated with different types of SSc. Antibodies against Scl-70, RP155 and RP11 are characteristic for the diffuse form, while antibodies against CENP A, CENP B and Th/To occur in the limited form. Antibodies against Ku, PM-Scl75 and PM-Scl100 are indicative of an overlap syndrome.

Predictors of disease course

Autoantibody determination can be useful for predicting the disease outcome and organ involvement. In a recent study, five major autoantibody clusters with specific clinical and serological associations were defined in patients with SSc, namely centromere, strong RNA polymerase III, weak RNA polymerase, Scl-70, and other autoantibodies. The separation of anti-RNA polymerase III into two clusters based on the intensity of the reaction is a new aspect and may reflect different temporal stages of SSc disease. In further studies, significant associations have been found between anti-Scl70 and interstitial lung disease, anti-RNA polymerase III and renal crisis, anti-Th/To and pulmonary hypertension, and anti-U1 RNP and pulmonary arterial hypertension. Autoantibodies against Scl70, RNA polymerase III and U1 RNP are, moreover, associated with significantly reduced survival compared to anti-centromere antibodies. Thus, sub-classification and disease stratification using autoantibodies may have clinical utility, particularly in early disease.

Furthermore, a frequent co-existence of various rheumatoid disease-associated antibodies, including CENP A, CENP B and Scl-70, with antibodies characteristic for primary biliary cirrhosis has been observed, emphasising the importance of considering both of these diseases during serological diagnostics.

Autoantibody detection strategy

Autoantibodies in SSc are screened by indirect immunofluorescence test (IIFT) on HEp-2 cells and primate liver and confirmed by monospecific tests. In IIFT, SSc-associated autoantibodies give rise to various fluorescence patterns, for example nucleolar (eg. anti-Scl-70, anti-PM-Scl100, anti-PM-Scl75, anti-RP11, anti-RP155, anti-Th/To, anti-NOR90, anti-fibrillarin), centromere (anti-CENP A and anti-CENP B) or speckled (e.g. anti-Ku). Some typical patterns are shown in Figure 1.

Multiplex immunoblots are highly suitable for confirming antibody specificities, as many different antigens can be included on the test strips and analysed in parallel. In particular, line blots fitted with individual membrane chips allow antigens with widely different properties to be combined on one test strip. A dedicated immunoblot for SSc, the EUROLINE Systemic Sclerosis (Nucleoli) Profile (Figure 2), allows confirmation of 12 SSc-associated autoantibodies simultaneously. In particular, it allows the differentiation of antibodies that show a nucleolar pattern in IIFT. The antigens contained in the profile are Scl-70, CENP A, CENP B, RNA polymerase III subunits RP11 and RP155, fibrillarin, NOR-90, Th/To, PM-Scl100, PM-Scl75, Ku and PDGFR (platelet derived growth factor receptor). Ro-52 is also included to provide additional diagnostic information, although Ro-52 antibodies are not specific for SSc.

Clinical prevalence data

In a published clinical study, sera from 129 patients with clinically characterised SSc (diffuse and limited form), 142 disease controls (myositis, systemic lupus erythematosus, rheumatoid arthritis) and 60 healthy blood donors were investigated with the EUROLINE profile (Table 1). In 85% of the SSc sera, antibodies against at least one of the 12 relevant SSc antigens were detected. The prevalences ranged from 65% for anti-Scl-70 to 1% for the very rare parameter anti-PDGFR. Specificities for the individual antigens were at least 98%. In further published studies using large panels of SSc patients and control subjects, the overall autoantibody positivity rates in SSc patients using the immunoblot amounted to between 76% and 89%, with varying prevalences for the individual autoantibodies depending on the cohort. The specificities for all parameters were very high (93% to 100%).

Confirmation of IIFT results

The panel of 129 SSc sera and 142 control sera described above was also investigated by IIFT on HEp-2 cells. 99% of the SSc sera displayed an IIFT positive reaction, showing the patterns nucleolar (97 sera), centromere (12 sera), overlap nucleolar/centromere (2 sera) or others (17 sera). The EUROLINE confirmed 100% of the sera with centromere pattern and 93% of the sera with nucleolar pattern, amounting to an overall confirmation rate of 94% for the SSc monospecific patterns. Of the controls only 17 showed a nucleolar pattern in IIFT, with only three of these demonstrating typical SSc antibodies. These three positive sera originated from patients with myositis, which might indicate an overlap syndrome in these individuals.

Fully automated immunoblot processing

The immunoblot for systemic sclerosis described here can be processed manually or fully automatically, for example, using the EUROBlotOne (Figure 3). This device provides complete automation of all steps, from sample data entry to report release. Up to 44 strips can be incubated per run, and it is possible to combine the systemic sclerosis profile with other immunoblot profiles in a single run. Preanalytical errors, due to wrong positioning of samples, are avoided thanks to the integrated barcode scanner. Moreover, the device automatically takes pictures of the strips with the integrated camera, and evaluates, interprets and archives them with the user-friendly EUROLineScan software.

Perspectives

The identification of novel SSc-specific autoantibodies has greatly enhanced the serological diagnosis of SSc. Alongside the major markers anti-Scl70, anti-centromere and anti-RNA polymerase III, many rarer autoantibodies now contribute to diagnostics. There is, moreover, a growing body of evidence that SSc antibodies can be used as predictors of disease outcome and organ involvement. Immunoblots such as the EUROLINE are an ideal method for multiparametric, monospecific determination of antibody specificities. They are fast, easy to interpret, and fully automatable, and can be used in any routine diagnostic laboratory. As further novel autoantibodies become identified, immunoblots can be easily supplemented with additional parameters. The SSc immunoblot profile is also useful for studies into the clinical utility of comprehensive autoantibody testing in SSc. It is anticipated that ongoing research will help to elucidate the associations between specific antibodies and particular disease courses and outcomes, and increase the understanding of the pathogenicity of this challenging disease.

Figure 1: IIFT patterns for A) anti-Scl-70, B) anti-centromere and C) anti-PM-Scl

Figure 2: EUROLINE Systemic Sclerosis (Nucleoli) Profile

Figure 3. EUROBlotOne for fully automated processing of immunoblots

Table 1. Autoantibodies in systemic sclerosis

Autoantibodies against**	Sensitivity	Specificity
Scl-70	65%	99%
CENP A	11%	99%
CENP B	13%	99%
RP11	5%	100%
RP155	7%	100%
Fibrillarin	2%	100%
NOR90	4%	99%
Th/To	6%	98%
PM-Scl100	7%	99%
PM-Scl75	12%	98%
Ku	6%	99%
PDGFR	1%	100%

**Analysed in 129 sera from SSc patients and 202 control sera

For the past 15 years, the laboratory medicine field has continued to exponentially evolve from one based on local and national practice to one based on globally harmonised best practices. Achieving and maintaining accreditation from an internationally recognised agency is one invaluable milestone for meeting essential quality practices. Simply stated, globally applicable standards are the international language for such a global transformation, and their use is essential to laboratories seeking accreditation. As a general rule, while accreditation requirements communicate to laboratories what to do, documentary standards frequently advise them how to do it.

Using Standards for Accreditation Preparedness

Annually, the United States Centers for Medicare & Medicaid Services Division of Laboratory Services publishes a Clinical Laboratory Improvement Amendments (CLIA) list of the top laboratory deficiencies cited during the accreditation process. The most recent summary from 2017 aggregates accreditation data from over 17,000 inspections. The most commonly cited deficiencies included such items as improper specimen storage and adequacy, improper equipment calibration verification, inadequate reagent and culture media storage, and improper patient identification. Deficiencies in personnel competency assessment were also at the top of the list.

Medical laboratory standards and guidelines provide practical advice to help laboratories address and correct deficiencies in order to achieve or maintain accreditation. These documents provide the guidance to successfully implement quality practices and address non-conformances. While accreditation requirements vary from country to country, globally accepted standards can be implemented in any laboratory, regardless of the accrediting body.

The Importance of Global Standards Harmonisation

The global harmonisation of standards is essential to the laboratory medicine field. The world has become a smaller place as a result of rapid advances in technology and ease and frequency of travel; people expect the same quality laboratory results, no matter where a test is performed. Additionally, responses to global disease outbreaks require the implementation of fast, reliable, and accurate medical laboratory testing. Indeed, every major communicable disease in the world can and should be diagnosed, monitored, and treated based on medical laboratory testing. Standards are essential tools for public health agencies responding to global epidemics (e.g., Ebola, MERS, SARS, Avian flu).

How are Best Practice Standards Developed?

There are two traditional paths to the development of international standards. One is the development of standards by national viewpoints within international forums—one nation, one vote. The International Organisation for Standardisation (ISO) is the largest standards development organisation in the world and is an example of this model. Standards developed by ISO in the field of laboratory medicine offer broad-based guidance and can be used by governments, industry, and practicing healthcare professionals to set strategy and direction for national, regional, and local best practices. The second path to global standards development involves direct participation by individuals—one person, one vote. One example is the Clinical and Laboratory Standards Institute (CLSI). CLSI is a not-for-profit, volunteer-led and driven organisation that brings together global experts to develop its standards in laboratory medicine. CLSI’s standards are developed using a consensus process which is open, inclusive and transparent. The authors of CLSI’s standards are expert volunteers and include balanced representation from government, industry, and the healthcare professions.

ISO and CLSI, as two examples, offer excellent standards and have a high degree of compatibility. In general, because of the national positions taken to develop ISO standards, they tend to be high level overarching documents which can be adapted for use at either the national or regional level. The best example of this is ISO 15189:2012; Medical laboratories—requirements for quality and competence, a quality management standard which has become the foundational standard for many national accreditation bodies. CLSI standards provide practical solutions for laboratories, and often include step-by-step processes and procedures.

Originally chartered as a US-based organisation, CLSI has evolved into a global association of 1,700+ organisational and individual members, as well as more than 2,000 volunteers—all working together to advance quality in healthcare testing. CLSI categorises its standards into nine expert committee areas:

• Automation and Informatics
• Clinical Chemistry and Toxicology
• Evaluation Protocols
• Hematology
• Immunology and Ligand Assay
• Microbiology
• Molecular Methods
• Point-of-Care Testing
• Quality Systems and Laboratory Practices

At his recent talk at the MedLab Dubai Laboratory Management general session, the CEO of CLSI, Glen Fine, MS, MBA spoke about preparation for laboratory accreditation. He highlighted the importance of using best practice standards in the laboratory and researching an accreditor’s sources for top cited deficiencies. In his talk, Mr. Fine noted, “As laboratorians we should never forget that accreditation is not a destination. Rather, it is one milestone in the journey of continual improvement that we undertake for all patients.”

As the Chair of the Haematology track, it is my great pleasure and a privilege to welcome you to the MEDLAB Americas Exhibition and Congress, that will take place in a few short months in sunny Orlando, Florida, USA. The overarching theme of this session is “Improving Efficiency in the Haematology Laboratory” and we were fortunate in securing a roster of content experts who will describe their experience in achieving more streamlined diagnostic processes, that ultimately lead to improved patient care. 

The topics that will be covered in the Haematology track are varied, and touch upon several broad diagnostic categories, as well as different areas of the Haematology laboratory. I will summarise some of the highlights in the remainder of this article. 

Our first featured speaker is Dr Stephanie Mathews, an assistant professor of Haematopathology from the University of North Carolina School of Medicine in Chapel Hill, North Carolina, USA. Dr Mathews specialises in the diagnosis of chronic myeloid neoplasms and is a consummate educator in her work with several professional societies, including the American Society for Clinical Pathology and the Society for Haematopathology. Dr Mathews will provide an overview of the updated classification and nomenclature of myelodysplastic syndromes, that will be listed in the upcoming 2016 version of the WHO Classification of Tumors of Haematopoietic and Lymphoid Tissue, and she will discuss the best practices in working up myelodysplastic syndromes, based on state-of-the-art best diagnostic approaches. 

This is a timely topic of practical utility, since haematologic malignancies comprise a unique spectrum of disorders as they are associated with significant morbidity and mortality, and the diagnostic algorithm is complex and involves a multidisciplinary approach, including clinical, morphologic, immunophenotypic, and cytogenetic findings, as outlined in the current WHO classification of haematolymphoid neoplasms. There is a constant process of improving and refining diagnostic, prognostic, and therapeutic modalities, in order to maximise favourable outcomes in this group of patients. Because of the amount of rapidly changing information in the specialties of Haematopathology and Haematology/Oncology, it is necessary for practitioners to be knowledgeable of the most recent developments in these fields, in order to provide the most optimal patient care.

Recent literature data have shown that only 33% of general pathologists are confident in diagnosis myelodysplastic syndromes (MDS), and professional organisations such as the American Society for Clinical Pathology and American Society of Haematology have identified myelodysplastic syndromes as a heterogeneous group of haematopoietic malignancies that represent a diagnostic challenge for pathologists.

In addition, surveys showed that neither general pathologists nor haematopathologists are comfortable using the International Prognostic Scoring System to characterise risk. This poses a problem, as accurate classification and prognostic scoring are essential to treating myelodysplastic syndromes. We hope that you will find Dr Matthew’s discussion helpful in becoming acquainted with the most recent national and professional consensus guidelines for the diagnosis of myelodysplastic syndromes. 

Our second distinguished speaker is Dr Chung-Che (Jeff) Chang, who is the medical director for Haematology and Molecular Diagnosis at Florida Hospital, and also serves as a professor of Pathology at the University of Central Florida, in Orlando, Florida, USA. Dr Chang has published extensively on diagnostic and molecular Haematopathology, and is intimately involved in educational and laboratory quality improvement activities as a member of the Haematology and Clinical Microscopy Resource Committee of the College of American Pathologists.

His talk will cover multiple myeloma, which is another topic of wide clinical interest. Multiple myeloma (MM) is a common haematologic malignancy (10-15% of haematopoietic neoplasms) and is defined by a triad of clinicopathologic criteria, including the presence of a serum or urine monoclonal protein; the presence of a clonal plasma cell population in the bone marrow (or plasmacytoma); and disease-related end-organ or tissue impairment, usually summarised under the CRAB acronym, and also including hyperviscosity, amyloidosis, or recurrent infections. 

The current diagnostic criteria, as listed in the 2008 WHO classification of haematolymphoid neoplasms and initially defined by the International Myeloma Working Group (IMWG) in 2003, apply to symptomatic MM (i.e. requiring therapy) and have been used for the past decade in clinical practice and research trials. However, the spectrum of plasma neoplasms encompasses other entities, such as monoclonal gammopathy of undetermined clinical significance (MGUS), asymptomatic or smoldering multiple myeloma (SMM), plasma cell leukaemia (PCL), solitary plasmacytoma, Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, and systemic AL light chain amyloidosis. 

From a clinical standpoint, it is postulated that Multiple myeloma is almost always preceded by MGUS, which is present in 3-4% of the general population age >50 years and has a rate of progression to MM of approximately 1% per year. The diagnostic criteria for MM, SMM, and MGUS have been recently updated by the IMWG and will be adopted by the 2016 WHO classification of haematolymphoid neoplasms.

The rationale for updating these definitions is based on observations from several studies that have identified a subset of patients with SMM who showed a much higher progression risk to MM, even in the absence of traditional CRAB features. The introduction of these new myeloma-defining biomarkers (such as BMPC≥60%, involved: uninvolved sFLC ratio≥100, and MRI findings with more than one focal lesion) removes the need for documenting end-organ damage as an obligatory requirement for the definition of a neoplastic condition (MM) and allows the identification of a cohort of SMM patients that may benefit from treatment initiation prior to the occurrence of irreversible end-organ damage. 

It is the recommendation of the IMWG that these criteria should be implemented in routine clinical practice and future trials. Furthermore, it proposes the consideration of flow cytometry-based potential future biomarkers for the diagnosis of a Multiple myeloma, such as high levels of circulating plasma cells and the presence of abnormal plasma cell immunophenotype≥ 95% (in combination with immunoparesis). With this background in mind, Dr Chang’s review will provide an overview of the best practices in the diagnosis of Multiple myeloma. 

I will then have the pleasure of discussing clinical and pathology features of aggressive B-cell lymphomas. This is an area of clinical interest not only for our group of oncologists at the Medical College of Wisconsin, where I practice Haematopathology as an associate professor, but also at national and international levels. In part, this is due to the updated classification of these entities in the 2016 WHO revision, and also spurred by the opportunity of developing local consensus guidelines for diagnosis and treatment, in the absence of national or professional benchmarks.

Our expertise is supported by literature data, that have shown how a second review of haematologic malignancy cases at academic institutions result in major diagnostic changes in as many as 15% of cases, of which 13% may have resulted in a therapeutic change, thus supporting the need of expert haematopathology review. My talk will cover the current classification of aggressive B-cell lymphomas, in the context of the 2016 WHO updates; prognostic algorithms in diffuse large B-cell lymphoma; biologic variables that impact prognosis in diffuse large B-cell lymphoma; and will conclude with some practical recommendations derived from our own clinical practice regarding locally-developed guidelines on the judicious work-up of “double hit” lymphomas. 

Finally, the Haematology track will be concluded by an expert speaker, Dr Juliana Gaitan from Florida Hospital in Orlando, Florida, USA, who will discuss quality, value and risk in transfusion medicine, thus providing a balanced counterpoint to the prior haematopathology-based talks.

I hope that this summary has provided you with a taste of the full-length discussions and raised your interest in coming to Orlando to listen to our speakers in person. Together, we can learn how to be more efficient in the Haematology laboratory, how to improve our own practice, and thus, how to better serve our patients. We look forward to seeing you at the Conference!

Dr Horatiu Olteanu will chair the MEDLAB Americas conference session on Haematology held under the theme, ‘Improving Efficiency in the Haematology Laboratory’, at the Florida International Medical Expo (FIME) on August 9, 2017.

Following 15 years of success in the Middle East, Asia and Africa, and with its recent launch in Europe, MEDLAB - a proven successful exhibition and conference model on an international scale – marks its debut in the Americas at the Florida International Medical Expo (FIME), to be held at the Orange County Convention Center, Orlando, Florida, from August 8-10, 2017.

Now in its 27^th year, the Florida International Medical Expo is without doubt, the largest medical trade fair across the Americas and serves as an opportunity for more than 1,500 national and international medical technology and device manufacturers to showcase new and refurbished medical and hospital equipment, technology, products and supplies. With 40 countries participating this year, FIME 2017 is expected to welcome more than 22,000 medical and healthcare trade professionals from North, Central and South America, as well as from across the globe.

With exceptional year-on-year growth within the already established MEDLAB portfolio, the launch edition of MEDLAB Americas is expected to satisfy the incessant demand for a broad medical laboratory expo in the Americas. 

Medical laboratory services form an indispensable part of the global healthcare diagnostics industry contributing to over 80% of healthcare diagnoses, according to a 2016 report by Global Market Insights, a US-based global market research and management consulting company. The demand for such services, adds the report, is constantly on the rise owing to multiple contributing factors including rising geriatric population, technological advancements, the existence of leading pharma, medi-tech and biotech companies and patient demand for newer, more specific testing.

The diagnostics and medical laboratories sectors (in vivo and in vitro) in the US are worth 40-45% of the global market and with annual growth projected at 0.9%, the demand for an annual networking opportunity to meet and do business and which also covers all areas of medical laboratories is high. This naturally paved the way for the launch of MEDLAB Americas which will now exist as a dedicated area onsite at FIME to cater to the medical lab industry across the Americas.

The launch edition will include an international offering of over 163 medical lab products/services from leading exhibitors from China, Germany, Korea, USA and more. MEDLAB Americas will also facilitate the exchange of knowledge and expertise with its three CME-accredited laboratory medicine and diagnostics conferences that will focus specifically on Clinical Microbiology, Haematology and Point of Care Testing (POCT). The tracks are CME accredited, offering up to 13.5 CME credits.

Bringing together leading laboratory experts, scientists, researchers, educators and clinicians, this premier interdisciplinary platform will enable them to present and discuss the most recent innovations, trends, and concerns as well as practical challenges encountered and solutions adopted in the modern medical laboratory.

The entire Laboratory Zone (exhibition + congress) is free to attend for registrations completed before July 24, 2017, following which an $80 registration fee will apply. Registration at the event will grant you access to all areas of FIME 2017 including exhibition halls featuring over 1,650 exhibitors from 40+ countries worldwide; over 500 medical devices, equipment and technology products/services; dedicated Dealers & Distributors Zone which connects dealers, distributors and agents with specific exhibitors; and seminars on medical device procurement and regulations across the Americas, and business skills to improve your ROI through sales and marketing.

Clinical laboratories in the USA represent an area of healthcare that is continuously evolving chiefly because of ongoing technological advances and external economic pressures. In the recent past, new diagnostic techniques and laboratory tests have been introduced as a result of both research on the fundamental pathogenesis of diseases and the development of new methods.

There are wide variations in the types of technology employed by different types of laboratories - technological innovations that have altered the way samples are collected and analysed and the way results are interpreted.

Addressing these broad challenges, the MEDLAB Americas Congress will provide unparalleled education and management solutions to help advance laboratory skills and improve laboratory services thereby fulfilling its ultimate objective of bridging the gap in medical knowledge. The conferences are provided by Cleveland Clinic and Informa Life Sciences Exhibitions, and supported by the College of American Pathologists.

Clinical Microbiology: August 8, 2017

For clinical scientists, young researchers, and consultants in clinical and medical microbiology, attendance at this day-long conference will give an insight into the most current research related to the laboratory diagnosis of human infections, role of the laboratory in both the management of infectious diseases and epidemiology of infections, and the latest developments in clinical microbiology.

With opening remarks by the Chair, Dr Robert Sautter, Consultant, RL Sautter Consulting LLC, Lancaster, South Carolina, USA; the Conference will also serve as an opportunity to discover key technological breakthroughs in diagnostic and therapeutic platforms to improve laboratory work processes and discuss challenges surrounding quality in specimen processing to reduce the chance of laboratory errors and improving patient care.

Haematology: August 9, 2017

Chaired by Dr Horatiu Olteanu, Associate Professor and Haematopathology Fellowship Director; Director, Clinical Flow Cytometry Laboratory, Department of Pathology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA; this medically-led conference aims to discuss a high-level of clinical and scientific guidance and support around test choice and test interpretation. This will include educational sessions in different aspects of haematopathology, haemoglobinopathies, coagulation, haemostasis and will also address everyday quality challenges in the haematology lab.

Attendees at the event will also learn about the importance of cytogenetic studies and molecular genetic studies to improve management of haematological malignancies; discover ways to assess the value and risks involved in transfusion medicine to reduce the chance of medical errors; and gain relevant information on the quality, value and risks of transfusion medicine.

Point of Care Testing: August 10, 2017

Academic and industry leaders under the Chair of Dr Edmunds Reineks, Director, Center for Point of Care Testing, Robert Tomsich Pathology and Lab Med Institute, Cleveland Clinic, Cleveland, Ohio, USA will discuss best practices in Point of Care Testing and disease management and the myriad challenges it presents for healthcare providers. They will also address the latest developments in regulatory requirements, validation, and clinical applications that ought to be considered for the integration of POC.

Attendees will learn of the connectivity between POCT instruments and electronic medical records to ensure quality of results; and understand how implementation of POCT can improve patient outcomes, lead to advanced care and faster diagnosis.

Over the last two decades multi-drug resistant microorganisms (MDROs) have been increasing in frequency and diversity. Overuse and misuse of antibiotics, as well as inadequate infection control, have led to the development of resistance and global spread of these organisms. One of the most significant consequences of antimicrobial resistance is the development of hospital acquired infections (HAI) that are resistant to most, if not all, antibiotics available. These infections lead to increased length of stay, delayed recuperation, long-term disability, higher mortality rate and costs to our healthcare system. To compound the problem, few new drugs are on the horizon to treat these infections.

Today, not only hospitalised patients but outpatients and the community at large are at risk of developing an infection with a pan-resistant organism. In the past (1960-1980), if a patient was infected with an organism such as Staphylococcus aureus, the clinician would inquire whether it was a community- or hospital-acquired strain based on the organism’s antibiotic susceptibility profile, e.g., methicillin susceptible (MSSA) or resistant (MRSA), respectively. Even though both strains could cause severe infections, MRSA generally was associated with a poorer prognosis as well as a higher morbidity and mortality. Therefore, we can no longer use the terms “hospital-acquired” and “community-acquired” strains with confidence.

What appears to be the first case of methicillin-resistant Staphylococcus aureus was described in the United Kingdom in 1961. By the 1970s, MRSA was widespread in Europe and in the late 1980s, in the U.S. This was just the tip of the iceberg. Numerous resistant organisms designated as Urgent, Serious and Concerning by the Centers for Disease Control and Prevention (CDC), have surfaced over the past decades due in part to a lack of a robust programme to decrease transmission across borders and within the United States. For many years we had the luxury of having at least a few effective broad-spectrum antibiotics to treat these MDROs. That is no longer the case. There are very few new antibiotics being created and we have limited treatment options. Whereas 16 new antibiotics were developed between 1983-87, a steady decline followed between 1988-2007, and only two new antibiotics have emerged between 2008-2012. 

This is only part of the story! We now have major concerns related to Carbapenem-Resistant Organisms (CROs) and Clostridium difficile, two organisms on CDC’s Urgent Threat List. We have seen a significant increase in infections due to these two pathogens attributed, at least in part, to a lack of infection control practices. There is no standard treatment to de-colonise patients with CROs in the GI tract as we have for patients colonised with MRSA. In an attempt to control the spread of CROs, often referred to as a “super bug”, U.S. healthcare facilities are now urged to use evidence-based medicine (EBM), stringent infection control practices and appropriate treatment regimens.

My talk at the MEDLAB Americas Conferences on Clinical Microbiology on 8^th August, 2017, will focus on CAUTI (Catheter-Associated Urinary Tract Infection), CLABSI (Central Line-Associated Bloodstream Infection), and surgical site infections (SSI) ; including MRSA, C. difficile and CROs. These are based upon laboratory data for CAUTI, CLABSI and SSI as a wide group of organisms can be detected there. The process, however, can be made more robust with laboratory guidelines and stringent adherence to proper procedures. In particular, robust pre-analytical, analytical, and post-analytical processes will make the process useful. Especially for SSI infections, about 70% or greater of infective agents come from within a given patient’s own flora and it is imperative that when performing surgeries good practices are followed and subsequent cultures sent to the lab are adequate. For example, sending tissue whenever possible and using swab cultures for only those times when tissue or fluid cannot be collected.

The National Healthcare Safety Network (NHSN) has been in operation for several decades. As stated on their website, “One of the primary purposes [of NHSN] is to lower hospital acquired infections by communication of facilities data to state and federal governments. The data used is laboratory data and the institutions are divided by type and specialty. There are acceptable levels of these infections per institution that are compared to ‘like’ institutions.”

For many years, this was helpful but decreases in risk to patients were not noticed at a level that was acceptable. A new policy is being rolled out to 17,000 medical facilities. “Current participants include acute care hospitals, long-term acute care hospitals, psychiatric hospitals, rehabilitation hospitals, outpatient dialysis centres, ambulatory surgery centres, and nursing homes, with hospitals and dialysis facilities representing the majority of facilities reporting data. Participation among the other facility types is expected to continue to grow in coming years.”

NHSN is a programme co-organised by the Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC). It wasn’t successful in the early years but sites are beginning to do better and are improving “better than average”. One reason is that starting in 2017 there will be decreased reimbursement for those not succeeding. A plethora of clinical care surveillance will be rolled out in the next 5-10 years. These results are available online for the public, healthcare institutions and public health to name a few.

By placing a reimbursement penalty on these organisations, CMS and CDC have “gained the attention” of the institutions and they have already responded positively. There is a trial period prior to institution of the penalties that seems to work.

EBM plays a role in this by informing healthcare by dealing with pre-analytic, analytic and post-analytic practices in the healthcare facility. Several agencies are working on these parameters to better laboratory testing. The EBM committee of the American Society for Microbiology/CDC is one such alliance working on laboratory EVB. One of the most important pre-analytic parameters that affects outcome is making sure that only patients that need testing get the tests ordered. In addition, the sample collection, storage and transport need to be done correctly to report appropriate results. The use of correct technology to dispense the most accurate and reliable results must be done. By reviewing the literature and also by evaluating appropriate treatment options, patient outcomes hopefully will improve.

Both Clostridium difficile (CDIFF) infection and Carbapenem-Resistant enterobacteriaceae (CRE) and Carbapenem Resistant Organisms (CRO) have been spreading at an alarming rate. CDIFF infections have gone undetected for many years as the method of detection has been lacking. Now with newer methods, more patients are being classified appropriately and we now know that many more people either are infected or carry the organism. Good infection control and treatment options will hopefully lower the rate of infection with this organism.

Also, infections with CRE and CRO have been exploding across the planet. It is without doubt one of the most dangerous healthcare related infections today. The problem with these organisms is that to date they cannot be decolonised from the intestinal tract. It has thus been transmitted to other patients in and out of the organisation. Serious infections with these have prompted the name “super bug” in the media. NHSN will be tracking this agent and hopefully will play a key role in lowering infection rates and result in better patient outcomes.

Examples of how this works will be used to show how rates have been lowered for certain infections resulting in better patient outcomes.

The laboratory plays a key role in this as well as other processes in the hospital and out-patient facilities. Members of the laboratory team should be heavily involved in Infection Control, Antibiotic Stewardship, Antibiotic subcommittee (often a sub committee of the Pharmacy committee), care teams, and administration. As much of the data that we are looking at nationally is generated by the laboratory, a laboratory expert needs to be involved in the healthcare committees looking at these global problems. For the aforementioned threats, a microbiologist or microbiology technologist might be the best choice. In any event, a representative from the laboratory needs to be involved.

This is a critical time in the battle against infections arising from hospital-acquired as well as community-acquired sources as there is a lack of treatment options for combating organisms that are resistant to most drugs available to us. For CRE and CRO we had to bring old drugs “out of the closet” to treat them as most other drugs are not effective against them. Two of the main drugs used against them today, polymyxin B and colistin, now used routinely, have not been used to treat patients for 30-40 years prior to outbreaks with these organisms. It is well past time to get serious in our control of these infections and Hospital Acquired Infections (HAI). Additionally, it is far past time to develop new antibiotics to aid us in this battle. This is a true challenge since drug development to approval is at a cost of approximately 800 million dollars and spans a time frame of 10 years or longer. But it is not just new antibiotics that we need, it is new methods of action of these drugs and also careful control of the use of new antibiotics so that development of resistance is slow. Adhering to infection control practices (which have been sorely lacking) is also paramount to success. We only have to look at the mistakes with MRSA to see what may be in store for the future. MRSA is still a huge threat and we have known about it for close to 60 years. We need to act now to assure safe healthcare systems.

Dr. Robert Sautter will chair the MEDLAB Americas conference session on Clinical Microbiology held under the theme, ‘Treating patients: How the laboratory works with other specialties’, at the Florida International Medical Expo (FIME) on August 8, 2017.