Kalorama Information’s report, The Market for Artificial Intelligence (AI) in Healthcare, quantifies the opportunity and future market opportunity for AI in healthcare, already an almost two-billion-dollar market, with applications in workflow and population health, drug discovery and emerging applications in diagnostics and other areas.

In the United States alone, there are roughly 38,000 patents containing the terms artificial intelligence or machine learning (excluding overlap terms).Of all the fields where artificial intelligence (AI) is promising, healthcare seems to be essential. This is because healthcare systems are plagued with problems of staff shortages, ineffective treatments, increased patient loads and incorrect diagnoses, all of which to a degree could be helped by new technology.

The global market for AI in healthcare is estimated at $1.9 billion by Kalorama Information. There are several hundred companies active in developing and marketing AI technologies for the health industry, in a variety of fields:

Population Health Management: Population health is a term that used to identify individual patients and groups of patients who are most likely to require some kind of medical intervention to stay healthy. After identifying these patients, healthcare personnel can target them at the optimal time to achieve favorable outcomes.  Amazon Web Services, CloudMedx, Google, IBM are among vendors in this area.

Workflow Solutions: With the droves of information that are contained in EMRs and the intersecting of artificial intelligence to compile that information, physicians, clinicians, nurses, patients and others will be able to make more informed decisions about healthcare diagnosis, delivery and personal wellness and disease management. AiCure, APIXIO,
Amazon Web Services, Google, IBM are notable vendors.

Imaging, Diagnostics and Disease Management: It is becoming increasingly clear that AI will transform the diagnostic imaging industry, both in terms of enhanced productivity, increased diagnostic accuracy, more personalized treatment planning, and ultimately, improved clinical outcomes. AI will play a key role in enabling radiology departments to cope with the ever-increasing volume of diagnostic imaging procedures, despite the chronic shortage of radiologists in many countries.

Drug Discovery & Development: Drug discovery and development are key aspects of healthcare. AI is being used in several areas of drug discovery and development. Through advancements in AI, it is now possible to automate drug design and compound selection. Researchers are using AI to select appropriate characteristics to design products that would reduce complexity in design, detect production and characterization issues and discover new entities. Atomwise, Berg Health, BioXcel Therapeutics, Cloud Pharmaceuticals, Recursion Pharmaceuticals, Sophia Genetics.

It’s no surprise that many pharmaceutical companies are developing treatments for a disease affecting millions with no current therapy.  That disease is Non-alcoholic fatty liver disease (NAFLD).  NASH is a  lifestyle disease (obesity and lack of exercise) and is distinct from other fatty liver diseases caused by alcohol abuse or medication side effects.  The symptoms of NASH are often invisible until the liver is damaged beyond repair.

In Kalorama’s most recent report, published in January 2020, we looked at the drugs in development and potential markets for NASH drugs.

More Information can be found in Kalorama Information’s NASH Drugs Pipeline and Market Overview.  

There are numerous products in development for the treatment of NASH. No medications have been approved specifically for NASH but some products such as pioglitazone and insulin sensitizers, Vitamin E and statins have been used to mitigate symptoms by controlling blood sugar and lowing lipid levels.
There are almost 80 products in development for the treatment of NASH. The bulk of products in development (41) are in Phase 2 clinical trials. Six products have moved on to Phase 3 and several of those have received Breakthrough Therapy Status or Fast Track Status.

The market for NASH treatments is difficult to predict due to a wide variety of variables and outcomes that could change as the industry progresses. Kalorama Information has determined the market size could reach $19.2 billion by 2025 using a variety of market indicators discussed throughout the report.
A number of trends will likely influence growth of the market including
 NASH disease incidence and prevalence
 NAFLD incidence and prevalence
 Risk factors
 Pricing trends
 Liver transplant statistics and trends
 Expected market penetration
 Global treatment options and emerging therapies

Companies that will likely have a competitive advantage in the NASH market include:
 Intercept
 Genfit
 Allergan
 Madrigal
 Immuron
 Galectin
 Gilead

 

 

 

From www.labpulse.com

December 24, 2019 — Testing blood for N-terminal pro b-type natriuretic peptide (NT-proBNP) appears to have value as a preoperative test to predict risk of cardiovascular (CV) events, according to a study published December 24 online in Annals of Internal Medicine. The results may prompt a rethink of cardiology guidelines, which currently do not advise its use in this setting, and clinical practice.

The retrospective study analyzed the association of higher levels of NT-ProBNP prior to surgery with risk for cardiovascular and vascular complications following procedures in 10,402 patients who were undergoing noncardiac surgery with an overnight stay. Participants had been enrolled in the Vascular Events in Noncardiac Surgery Patients Cohort Evaluation (VISION) study, and NT-proBNP and troponin T levels had been tested prior to surgery.

The study was funded by the Canadian Institutes of Health Research, and the results were reported by Dr. PJ Devereaux, PhD, a professor of medicine at McMaster University and a cardiologist at Hamilton Health Sciences in Ontario.

Compared with NT-proBNP levels less than 100 pg/mL, those with levels of 100 pg/mL to less than 200 pg/mL, 200 pg/mL to less than 1500 pg/mL, and 1500 pg/mL or greater were associated with significantly higher event rates (adjusted hazard ratios of 2.27, 3.63, and 5.82, respectively), the authors reported.

“Adding NT-proBNP thresholds to clinical stratification (that is, the Revised Cardiac Risk Index [RCRI]) resulted in a net absolute reclassification improvement of 258 per 1,000 patients,” Deveraux and colleagues reported. “Preoperative NT-proBNP values were also statistically significantly associated with 30-day all-cause mortality.”

A common complication

Myocardial injury after noncardiac surgery (MINS) is the most common major vascular complication after surgery and is associated with perioperative death, and accurate preoperative cardiovascular risk prediction is important for guiding decisions about whether surgery is appropriate and how patients should be managed, the authors noted.

In an accompanying editorial, also published in the Annals of Internal Medicine on December 24, New York University cardiologists Drs. Arman Qamar and Sripal Bangalore wrote that the results represent the largest study evaluating NT-proBNP in a preoperative setting. The test is sensitive for detecting myocardial wall stress and structural changes, they noted, so the findings are not surprising.

“Nonetheless, this study is a major step forward in advancing the use of biomarkers for preoperative cardiac risk assessment,” Qamar and Bangalore wrote.

They noted that the evidence for NT-proBNP testing as a prognostic tool for stratifying risk before surgery is “unquestionable,” yet this is not part of routine clinical practice nor is it advised for routine use by cardiology associations in the U.S. and Europe, including the American College of Cardiology and American Heart Association, as well as the European Society of Cardiology.

“Thus, given the well-known limitations of clinical risk indices and noninvasive cardiac diagnostic testing in preoperative risk prediction, evaluation of NT-proBNP in addition to clinical factors offers a readily available, precise, and inexpensive tool for risk stratification,” the authors wrote in their editorial. “However, whether NT-proBNP–driven perioperative management reduces the risk for cardiovascular events is unknown and should be investigated.”

 

Karius, a life sciences company, announced today that JAMA Oncology published a clinical study showing that the Karius Test detected bloodstream infections before the onset of clinical symptoms in high-risk pediatric patients with relapsed or refractory leukemia. The study was performed by researchers at St. Jude Children’s Research Hospital and provides the first evidence that the Karius Test can predict infections.

The Karius Test is a non-invasive blood test that uses next-generation sequencing of microbial cell-free DNA to rapidly detect over 1,400 bacteria, DNA viruses, fungi, and parasites. The test is primarily used to detect specific causative pathogens in complicated pneumonia, cardiovascular infections, and infections in immunocompromised patients.

Infections are a leading cause of death for patients with leukemia in the United States. Patients treated with chemotherapy for cancers, such as leukemia, have a high risk of life-threatening infections. Some children with leukemia have a higher chance of dying from an infection than from the cancer itself.  Currently, broad-spectrum antimicrobial prophylaxis is used to prevent infections and then empiric antimicrobial treatment is started at the onset of signs or symptoms of infection. A non-invasive plasma-based predictive screening test for infections may allow pre-emptive targeted antimicrobial therapy before symptom onset and may improve clinical outcomes.

“Parents of children with cancer often wish that they had a crystal ball to know what’s coming next; this might just be that…” said Josh Wolf, M.D., Ph.D., co-author and Associate Member of the Department of Infectious Diseases at St. Jude Children’s Research Hospital.

Of the 47 pediatric patients enrolled in the study, 12 patients developed a total of 19 bloodstream infections, and samples for evaluation of predictive diagnosis were available for 16 episodes. The Karius Test detected a bloodstream infection in 75 percent of cases (12/16) as early as three days before patients became symptomatic.

“There is an important signal here suggesting an ability to predict infections in this vulnerable population even before the development of clinical symptoms,” said co-author and Senior Medical Director at Karius, Asim Ahmed, M.D. “The Karius Test is not currently a screening test; additional studies are needed to guide how this test can be used in the clinical work-flow to help predict and prevent infections in patients with immunocompromising conditions.”

This study will be expanded to further analyze the Karius Test’s ability to identify bloodstream infections before symptoms arise.

The research at St. Jude was funded in part by the following: Karius Inc.; the Burroughs Wellcome Fund; the Hyundai Foundation of Pediatric Cancer Research; the Leukemia and Lymphoma Society; and ALSAC, St. Jude’s fundraising and awareness organization.

Live cell imaging technologies have become an essential component of life science research on a global scale. Over the years, live cell imaging technologies have become easier to use for customers to conduct their research, such as drug discovery. Also, the market’s consumables and aftermarket products have experienced an increase in demand due to their multiple uses in various research environments, such as for the creation of 3D cell modeling and measurement of a cell’s health over time.

In November 2019, IBO’s publisher, Strategic Directions International, released the “2019 Market for Live Cell Imaging” report, which examines trends, and regional and industrial demands of the live cell imaging market. The report categorizes live cell imaging instruments into five technology sectors: optical microscopy, confocal microscopy, advanced microscopy, high-content analysis, and assays & labeling. Also, the report outlines the leading companies offering these technologies, which include Leica Microsystems (Danaher), ZEISS, Nikon, Thermo Fisher Scientific, Olympus and others.

According to the report, in 2018, the live cell imaging market was estimated at over $1.3 billion and is projected to achieve high single-digit sales growth reaching $1.9 billion by 2023. Advanced microscopes, high-content analysis systems and optical microscopes will account for most of the systems shipped.

The advanced microscopy, and assays & labeling technologies are forecast to be the two fastest growing sectors, with sales for both rising in the high single digits by 2023. Leica Microsystems, ZEISS and LaVision BioTec are the leading companies that provided advanced microscopy products, while Bachem, Essen and Thermo Fisher are the leaders in the assays & labeling business.

Within the advanced microscopy technology sector, multi-photon and light-sheet microscopy technologies are the primary revenue drivers due to vendors introducing improved commercial systems. Also, service and aftermarket products contribute to this technology sector’s market revenues. The imaging assays & labeling reagents technology sector encompass the highest percentage of live cell imaging consumables, with imaging assays representing a fifth of the consumables sub-market. The demand for labeling reagents stems from ongoing innovation.

Geographically, in 2018, the US and Canada, and Europe were the two largest regional markets for live cell imaging technologies, with China being the fastest growing region. All of these regions experienced high demand from the academic, pharmaceutical and life science end-markets. The report forecasts that all three regions’ sales growth will rise in the high single digits by 2023.

End-market wise, the pharmaceutical/biotech, academia and government end-markets accounted for the most live cell imaging sales in 2018. Both the academic and government end-markets utilize live cell imaging tools to study cellular processes and record qualitative data. While the pharmaceutical/biotech sector uses the technology to conduct biopharmaceutical therapeutic drug development, the report also states that the demand for live cell imaging tools will increase in hospitals and clinics due to the application of personalized medicine and cancer treatments.

Between 2017 and 2019, M&A was also a component of sales growth for the live cell imaging market. Bruker acquired the light-sheet microscopy manufacturer LUXENDO for an undisclosed amount in 2017 in order to diversify its advanced microscopy portfolio (see IBO 5/15/17). The next year, Bruker expanded its atomic force microscopy capabilities through the purchase of JPK Instruments, a supplier of biomolecular and cell imaging microscopes (see IBO 7/15/18). This year, BioTek Instruments, a maker of cell imaging plate readers, was acquired by Agilent Technologies for $1.2 billion (see IBO 7/15/19).

Highly effective cancer therapies. Handheld hematology analyzers. A new and untapped world market. Social media selling life science tools. Science and Medicine Group publications, including Kalorama Information, Strategic Directions International (SDi), Bioinformatics, and IMV have made various projections for the new year in imaging, diagnostics, biotechnology, and life science instrument and supplies that can help marketers determine their plans next year. These projections are the result of analysis in the scores of detailed publications produced by these brands.

The list below includes the top 10 predictions for 2020:

  1. CAR-T therapy revenue will exceed $1 billion next year: CAR-T cancer therapeutics, which use the patient’s own immune cells to attack cancer, will earn more than $700 million this year for the two companies that market them. And it’s likely these therapies will exceed $1 billion in revenue in 2020 as new products are approved. This is according to Kalorama Information (www.kaloramainformation.com). The reason is their track record in treating patients with little or no treatment options.  CAR-T therapy involves using T cells from the patient and genetically engineering those cells using a disarmed virus so that the cells produce receptors called CARS that can attack cancer. It has shown effectiveness in some lymphomas and leukemias, and next year one or more products for myeloma are expected. Science and Medicine Group thought leaders and representatives were at the American Society of Hematology meeting in Orlando, FL, where significant studies were released on CAR-T safety and efficacy, as well as new products announced.
  2. Social media will be the best tool for selling life science instruments: According to “Life Science Customer Purchasing Journey: Finding Customers Along the Way” https://bioinfoinc.com/product/life-science-customer-purchasing-journey/ scientists look to other scientists when they need a tool to solve an experimental problem. The report, which describes the purchasing habits of life science tool buyers, is the result of a survey of scientists. Among the findings were that 72% trust their colleagues over websites and 71% look to fellow scientists over sales reps. These are just two of the many facts detailed in the report. Instrument buyers will need to see feedback from their colleagues in order to be influenced in a purchase decision, according to the report. Social media reflects the best forum for this to happen. The report also gets into other topics and finds that good customer service will be essential for sales in 2020.
  3. Instrument makers will target the ASEAN countries: The Association of Southeast Asian Nations (ASEAN) is a multinational economic and political alliance founded in 1967 by Thailand, the Philippines, Malaysia, Singapore, and Thailand. If the ASEAN group were a single nation, it would rank third in population, after India. It would also be the eighth largest market in the world. While not one nation, in 2015, the ASEAN Economic Community was established to create a single market for free trade of goods, services, and labor across the region, similar to the single market free trade within the European Union. According to SDi’s report on the Southeast Asia instrument markets (https://strategic-directions.com/product/2019-asia-pacific-instrumentation/), this group of Southeast Asian nations is projected to have the fastest growth in the analytical instrumentation market in the next five years due to its burgeoning pharma/bio sector. Furthermore, the ASEAN’s policies and foreign investments will bolster the pharma/bio sector contributing even more to the region’s growth. While places like Singapore and Taiwan have well-established pharma/bio industries, other countries like Thailand and Malaysia look to grow domestic production and research for pharmaceuticals.
  4. Imaging procedure volume, especially for CT and MRI, will increase around the world: Results are in from IMV’s Global Radiologist Survey, part of its “Global Imaging Market Outlook Report” (https://imvinfo.com/product/imv-2019-global-imaging-market-outlook-report/). Over 300 respondents participated in IMV’s global survey, and they represent key opinion leaders, with nearly half of the respondents being the chair/chief/heads of their radiology departments and over half being practicing radiologists. Overall, these opinion leaders are optimistic about the growth of imaging in their countries, with 80% saying their imaging procedure volume will increase. Respondents in the emerging markets are more optimistic about their outlook for increases in imaging procedures than those in the developed markets. The top two modalities planned in all 10 global regions are CT and MRI.
  5. That doesn’t mean all global hospitals are ready: IMV’s survey also found that solutions to address this procedure growth may be a challenge. Only one-quarter of the respondents feel their “capacity is sufficient to meet their needs over the next two to three years,” but their prospects for acquiring imaging equipment may be inhibited by delays in their internal and governmental approval processes and local economic conditions. Respondents in Latin America, the Middle East, and Africa are particularly concerned about their local economy limiting their capital budgets for imaging equipment, and they are very cost-conscious about equipment and service pricing while seeking reliable equipment and responsive service in their environments.
  6. Preparation for sequencing will be a $2 billion+ market: The increasingly routine use of sequencing in clinical settings is creating tremendous opportunities for suppliers of sequencing instrumentation and consumables, including those required for preanalytical preparation of samples from biological materials. In fact, clinical applications will drive double-digit growth for the NGS sample preparation market over the next five years. SDi’s newly published report, Sample Preparation for Next-Generation Sequencing(https://strategic-directions.com/product/2019-next-generation-sequencing-sample-preparation-market/), provides an in-depth analysis of how precision medicine and other applications are shaping demand for next-generation sequencing (NGS) sample preparation techniques. The report finds these products earned $1.8 billion this year and will push beyond $2 billion in 2020.
  7. AI will find its best home in imaging: IMV’s Global Radiologists Survey findings also confirmed the future of artificial intelligence (AI) and machine-learning tools for imaging in 2020 and beyond. The top-ranked potential use for AI that respondents cited was “capabilities to more precisely diagnose patient conditions and enhance personalized medicine.” It’s not all positive — in their comments on potential uses, some radiologists see the potential for AI to improve clinical decision support and image quality, but others expressed concern on when and how AI applications will be integrated into their routine practice and daily workflow, as well as work seamlessly with their imaging equipment, PACS, and RIS.
  8. Ascendance of mass spectrometry as a clinical instrument continues: Within the analytical instrumentation industry, mass spectrometry is certainly one of the most dynamic areas for growth over the next several years. Its increasingly sensitive analytical capabilities and enhancements continue to bring the technology to the edge of new scientific discovery and research applications. While SDi covers the market for eight separate mass spectrometry techniques in its flagship publication, the “Global Assessment Report,” it does so from a broad perspective that looks across all end markets. Clinical mass spectrometry, however, is one particular end market that has been at the root of very rapid mass spectrometry growth over the past few years — and will continue to be in 2020 and for the foreseeable future. SDi’s latest publication, “The 2019 Mass Spectrometry Market for Clinical Applications” (https://strategic-directions.com/product/2019-clinical-mass-spectrometry/), dives into the world of clinical diagnostics to examine how robust the demand from laboratories in this space is shaping the market for mass spectrometry technologies. The report presents market data and insights into six categories of clinical mass spectrometry, although two categories in particular are responsible for the most disruptive market influences in recent years: MALDI-TOF and triple quadrupole LC/MS.
  9. Multiphoton microscopy makes gains: According to SDi’s “2019 Market for Live Cell Imaging” report (https://strategic-directions.com/product/2019-live-cell-imaging-market/), the total market for live cell imaging instruments, assays, and labeling reagents is projected to reach $1.9 billion in five years. Among the factors driving this high growth is the increasing adoption of advanced microscopy techniques for live cell imaging, namely multiphoton microscopy and light sheet microscopy. Multiphoton microscopy, also called two-photon excitation microscopy, makes use of nonlinear optics to provide finely localized, three-dimensional imaging. Instead of using optics to control the light returning to the detector, multiphoton optics ensure that the stimulated part of the sample is restricted to a small point, which reduces the risk of photobleaching effects. Light sheet microscopy, also called single-plane illumination microscopy, illuminates only a thin plane of just a few micrometers at a time using a laser. As the sample is moved through the light sheet, three-dimensional images are generated. Since only a thin slice of the sample is exposed at a time, light sheet microscopy is a relatively gentle technique for live cell imaging and can be used to image cells in living animals.
  10. Hematology testing goes handheld: Hematology is important for a workup in annual exams and hospital inpatients. The basis of hematology testing is the complete blood count (CBC) that provides information on blood components: hemoglobin, hematocrit, red blood cells, white blood cells, reticulocytes, and platelets. Kalorama Information has covered hematology for decades in its “The Worldwide Market for In Vitro Diagnostic Tests” (https://kaloramainformation.com/product/the-world-market-for-in-vitro-diagnostic-tests-12th-edition/) and says these devices are now getting smaller and useable at the point of care (POC) — a trend that will continue in 2020. A number of handheld and benchtop analyzers are available for POC professional hematology procedures. Among the producers of these products are Beckman Coulter, Diatron, GlysBy Diagnostics, HemoCue (Radiometer/Danaher), Horiba, Roche, and Sysmex. Hematology will remain the second-largest volume of global in vitro diagnostic procedures, with the number of tests increasing 5.3% per year to nearly 6.7 billion in 2024. The total worldwide volume of POC professional hematology testing procedures conducted is predicted to expand 4.4% annually to 424 million in 2024. Uses in general health screening and the diagnosis and monitoring of blood-related disorders during hospital stays, emergency room visits, and physicians’ consultations will account for growth. The availability of complete blood counts on high-throughput clinical chemistry systems will moderate a faster rise in procedure volume.

The point of care diagnostic testing market is over $22 billion, about 2/3rds of that is self-care and physician office based testing.

Point of care testing offers significant benefits in time-to-results, time-to-treatment, diagnostic relevance to providers and even patient confidence.  They tend to cost more than lab-based tests, but in an overall context of care cost, they can prove to contribute to overall savings and outcomes improvement.

Kalorama Information presented at the BioMedevice San Jose – https://biomedevicesanjose.com/ The Presentation will be on “Point of Care: Fast Growth,  New Products, Disruptive Trends. ”

Some key points

  • Point of Care Grows Faster
  • Point of Care Needs to Prove Benefits.
  • As more than a fourth of the IVD market, POC has withstood cost challenges
  •  Cardiac, HbA1c, Tumor Markers, FOB among fast-growing segments

    For a copy of Kalorama Publisher Bruce Carlson’s presentation at the event, please email bruce.carlson@kaloramainformation.com

For More Information on the Point of Care Market, See Kalorama Information’s report:

The Worldwide Market for Point-of-Care (POC) Testing (Infectious Disease Testing, POC Cancer Tests, Rapid Coagulation, Urine Testing, Lipid Tests, Pregnancy Testing, Glucose Testing and Other POC)

 

Hematology is the study of peripheral blood and bone marrow cells in order to diagnose various diseases of the blood including leukemias, anemia and autoimmune diseases. Kalorama Information has covered hematology for decades in its report The Worldwide Market for In Vitro Diagnostic Tests https://kaloramainformation.com/product/the-world-market-for-in-vitro-diagnostic-tests-12th-edition/

The basis of hematology testing is the complete blood count (CBC) that provides information on blood components: hemoglobin, hematocrit, red blood cells, white blood cells, reticulocytes, platelets. The CBC is run as part of the normal work up in an annual health exam and for every inpatient. A drop of blood is placed on a microscope slide and stained. The slide is then examined under a microscope and the cells are analyzed.

Hematology will remain the second-largest volume of global IVD procedures, with the number of tests increasing 5.3% per year to nearly 6.7 billion in 2024. Growth in related IVD product sales during the same timeframe will expand 5.5% annually to over $5.6 billion.

The menu of hematology tests includes: CBC + 5-Part Differential (or 3-part Differential), Manual Differential/Review, Hematocrit, Hemoglobin (Automated, Manual), Sedimentation Rate, Reticulocyte Count, white blood cell (WBC) count, platelet count and analysis, and red blood cell count (RBC).

There is continued discussion as to the need for a full 5-part differential versus a 3-part differential. White blood cells, or leukocytes, are the immune system’s primary defensive against infection and disease. Therefore, measuring the level of white blood cells in blood enables clinicians to easily detect and monitor various conditions.

The 3-part provides a count of WBC types: granulocytes, monocytes and lymphocytes. The 5-part provides a more advanced WBC count of neutrophils, lymphocytes, monocytes, eosinophils and basophils.

Each WBC serves a different function, which is why most laboratories prefer to count for all of them. Lymphocytes attack specific viruses and bacteria, neutrophils combat bacteria; eosinophils target parasites and certain infections; monocytes respond to inflammation and replenish white blood cells in bodily tissue; and basophils, the rarest type, attack certain parasites. All high-volume systems provide at least a 5-part and many smaller instruments do as well.

However, depending on the facility’s level of expertise and budget a 3-part differential may fulfill its need. In fact, vendors are still marketing 3-part instruments with sophisticated sample management enhancements.

Today and over the past 50 years, the CBC has made an enormous impact on patient care. A CBC is run on every hospitalized patient and it is a vital part of a yearly annual checkup. The information clinicians derive from the CBC is used in the evaluation of just about every medical condition.

Since the late 1990s hematology cell counting progressed from impedance-based technology (the basis of the Coulter Principle) by borrowing from flow cytometry. Incorporation of laser excitation and fluorescence detection into the hematology analyzer has grown the instruments’ cell discrimination abilities to include blood cell components that required labor intensive and inexact manual methods. This one significant addition also created automated flow cytometers for the hematology laboratory.

Hematology analyzer product differentiation is accomplished by adding new parameters to a basic instrument—such as platelet counting, reticulocyte counting and CD4/CD8 analysis. The second approach is expansion into body fluids other than blood. The third avenue for differentiation is in automation strategies that include integration onto a core lab automation track, the addition of an automated slide maker and stainer, cell imaging technology and bioinformatic software. These strategies have already been put in place by all of the players.

Thus, hematology vendors have perfected high-end hematology analyzers to perform a number of specialized tests that are now available on-demand and almost instantaneously. Using the cell staining and counting capabilities of high-end hematology analyzers allows labs to automate fluid analyses such as CSF. Abbott Diagnostics, Beckman Coulter/Danaher, Siemens Healthineers and Horiba offer specialized platelet, red blood cell and white blood cell analysis and automatic slide makers/stainers. This feature decreases the number of differential slides that have to be made to only those samples with really abnormal cells.

POC Professional Hematology Testing
The total worldwide volume of POC professional hematology testing procedures conducted is predicted to expand 4.4% annually to 424 million in 2024. Uses in general health screening and the diagnosis and monitoring of blood-related disorders during hospital stays, emergency room visits, and physicians’ consultations will account for growth. The availability of complete blood counts on high-throughput clinical chemistry systems will moderate a faster rise in procedure volume.
Hematology is the study of peripheral blood and bone marrow cells in order to diagnose various diseases of the blood including leukemias, anemia, and autoimmune diseases. The basis of hematology testing is the complete blood count (CBC) that provides information on the blood components hemoglobin, hematocrit, red blood cells, white blood cells, reticulocytes, platelets. The CBC is performed as a component of annual physical examinations and pre-hospital admission testing. Samples that exhibit abnormal levels of any blood component undergo a microscopic examination of cell contents known as a blood cell differential procedure.

Other POC professional hematology procedures include hemoglobin and hematocrit, tests. Hemoglobin is a protein in red blood cells that carries oxygen to organs and tissues and transports carbon dioxide from organs and tissues back to the lungs. A low level of this substance is a symptom of anemia. An excessive level of hemoglobin indicates that the patient may be afflicted with the blood disorder polycythemia vera.
A hematocrit test measures the proportion of red blood cells in the blood. Red blood cells carry oxygen throughout the body. Deficiencies in these cells is associated with a number of conditions, including anemia, vitamin or mineral deficiencies, and blood loss. A higher than normal hematocrit ratio is manifest in patients with dehydration, polycythemia vera, and heart and lung diseases.

A number of hand-held and benchtop analyzers are available for POC professional hematology procedures. Among the producers of these products are Beckman Coulter, Diatron, GlysBy Diagnostics, HemoCue (Radiometer/Danaher), Horiba, Roche, and Sysmex.

Molecular vendors met in Baltimore at the Association for Molecular Pathology meeting in Baltimore Wednesday for pre-convention corporate workshops and presentations. Not surprisingly, some news was made. Several vendors presented new solutions to chip away at result times. Thermo Fisher Scientific launched its Ion Torrent Genexus System, an integrated next-generation sequencing (NGS) platform featuring an automated specimen-to-report workflow that delivers results in a single day.

The company said its turnkey solution makes it realistic in the future that local hospitals could adopt NGS testing. It’s common now for hospitals to use a single-gene test, or outsource their complex genomic profiling to a reference lab, and that can take several weeks and require larger sample inputs, Thermo says. Larger sample input can lead to more quantity not sufficient (QNS) reports, meaning results are inconclusive.

“We can envision a time when patients at local hospitals will have faster access to comprehensive test results that can guide more effective, targeted therapy selection and improved health outcomes.” said Mark Stevenson, executive vice president and chief operating officer at Thermo Fisher Scientific.

Other developments include:

· Sequencing giant Illumina used the AMP meeting to announce the launch of TruSight™ Oncology 500 ctDNA (TSO 500 ctDNA), Illumina’s first liquid biopsy solution for detecting cancer biomarkers. The company said TruSIght provides labs the flexibility to analyze both tissue and liquid biopsy samples to uncover biomarkers using liquid biopsy where tissue samples are limited or unavailable, or to complement to tissue results by detecting biomarkers in circulating tumor DNA. The company also announced a high throughput system 500 Oncology High-Throughput, that can run up to 192 tissue samples on the NovaSeq 6000

· Carlsbad, CA-based ChromaCode, a target enrichment company announced the launch of its Multi-Drug Resistance (MDR) Panel. The system combines proprietary data science algorithms with widely-used, low-cost chemistries to enhance the multiplexing levels of common real-time and digital PCR instruments for detection of 5-50 targets in a single reaction. The company also detailed the performance of its HPDCR Tick-Borne Pathogen (TBP) Panel.

· Qiagen announced its simultaneous DNA/RNA Multimodal Panels, QIAseq, for comprehensive solid and liquid tumor profiling. The company said the product is the only solution to extract, enrich and sequence DNA variants and RNA fusions and assess gene expression in a single workflow from a single sample within a single day, where typically workflow is 2-3 days. The system uses an input as low as 10 ng of total nucleic acid, which conserves samples and reduces sample-induced bias present in other systems.

· Paragon Genomics announced several products including its CleanPlex® Hereditary Cancer Panel V2. The company said the product facilitates same-Day risk assessment of multiple hereditary cancers with reduced sample input, ease-of-use improvements and a 3-hour workflow. · Purigen Biosystems announced the launch of its small benchtop Ionic™ Purification System system, which utilizes the company’s core isotachophoresis (ITP) technology to extract, purify, and concentrate nucleic acids from biological samples in one hour with less than three minutes of hands-on time per sample.

· Menarini Silicon Biosystems debuted its new VRNxT™ volume reduction instrument for rare-cell and single-cell analysis. VRNxT removes manual pipetting steps. No specific skill sets or training are required for operation, thereby delivering user-independent results with high reproducibility and success, with 99% of single cells retained after volume reduction.

· Biocartis highlighted five opinion-leader studies that boosted its Idylla system, its real-time PCR based molecular diagnostics system. The company said the respective Idylla™ studies showed a strong performance of Idylla™ assays (RUO) compared to other methods including IHC2 and NGS3 in terms of concordance4, ease of use, workflow automation and turnaround times. For instance: Memorial Sloan Kettering Cancer Center researched the rapid assessment of EGFR, KRAS and BRAF mutations and MSI status on Idylla and found the system demonstrated excellent reproducibility as well as 100% concordance with reference methods, while a University of Alabama study concluded that the Idylla KRAS Mutation Assay could be an alternative method to rescue samples that appeared inadequate for a larger NGS-based panel, with the added benefit of a fast two-hour turnaround time.

· Asuragen highlighted user experiences with its new AmplideX® PCR/CE SMN1/2 Plus Kit for the quantification of SMN1 exon 7 copy number from whole blood and buccal samples. The company also featured its QuantideX® qPCR BCR-ABL IS Kit, QuantideX® qPCR BCR-ABL minor Kits and its NGS portfolio.

As molecular pathologists, pharmaceutical companies and in vitro diagnostic vendors gather in Baltimore MD for the upcoming Association for Molecular Pathology (AMP) in Baltimore, MD. corporate workshops have been announced.  The workshops indicate the direction the industry is going, with new molecular technologies such as mass spec and NGS replacing traditional ones in some cases.   Roche, Abbott Diagnostics, Qiagen, Thermo Fisher, Quidel, and Beckman Coulter are among IVD vendors that will exhibit at the meeting and run workshops and presentations.

The molecular diagnostics market is estimated at 8.7 billion, per our most recent report on molecular diagnostics:

Molecular pathology vendor workshops that have been announced include:

Next-Generation Sequencing:  News of the recent proposed expansion of Medicare coverage for next-generation sequencing testing should be good news for vendors.  (https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=296).  Many vendors will present on the topic – Qiagen will focus on the key bottle neck of clinical NGS test interpretation – with a seminar about reducing interpretation times by 85%.  Twist Bioscience will present: “Leading the Way in Target Enrichment.  Beckman Coulter Life Science will host “Implementation of Automated Comprehensive NGS Panel at a Community Cancer Center”  presented by Dr. Qi Wei, Assistant Professor Department of Biomedical Informatics at Vanderbilt University.

Other workshops related to NGS include Asuragen’s which will be highlighting its NGS-in-a-Box solution for DNA and RNA variants.  Arc Bio will focus on NGS-based metagenomics for micro labs; and Bio-Rad will be demonstrating orthogonal methods for validation and confirmation of NGS.   Archer Dx will focus on blood cancers.  The company’s panels can characterize  fusions, CNV and other variants. Karius will discuss its test which the company says can identify microbial-free DNA from plasma in patients with severe infection.

Mass Spectrometry: Agena Bioscience will feature “Low Cost, High Sensitivity: The Advantages of MALDI-TOF for Liquid Biopsy and Solid Tumor Profiling.”  The company’s MassARRAY system detects genetic variation directly by label-free mass spectrometry.  Its highly sensitive, multiplexed UltraSEEK technology, on the MassARRAY system can detect low levels of variants, which can be useful for analysis of somatic tumors.

SMN1/2:  Survival Motor Nueron protein is one of a group of proteins called the SMN complex, which is important for the maintenance of specialized nerve cells called motor neurons.   Many mutations in the SMN1 gene have been found to cause spinal muscular atrophy.  Asuragen will demonstrate  AmplideX PCR/CE SMN1/2 Plus Kit, which the company says offers rapid turnaround time, and automated results reporting software, the assay provides a simple and scalable SMN1 solution for all laboratories.

BCR-ABL monitoring:  Each year 1.0-1.5 newly diagnosed Chronic Myelogenous Leukemia (CML) patients are identified per 100,000 individuals.   CML prevalence is estimated to increase at an annual rate of 4%, and the number of individuals living with this disease will double by 2030.  CML is treated with a TKI called imatinib that targets the BCR-ABL fusion protein but assessing treatment efficacy for CML requires a molecular diagnostic.   Asuragen will demonstrate their FDA-cleared assay for highly sensitive BCR-ABL monitoring and Cepheid  will show its Xpert BCR-ABL Ultra test which automates the entire test process in one cartridge.

Liquid Biopsy: Roche will be demonstrating his Pan Liquid Biopsy Testing AVENIO ctDNA Clinical Research Story: Surveillance & Monitoring  All four mutation classes (SNVs, indels, fusions and CNVs) in a single DNA workflow with exceptional sensitivity and specificity.  Exactly-matched tissue and ctDNA panels (same genes, gene regions and hybrid-capture workflow) for true concordance.   The company says the test reports in 5 days.     Illumina’s new oncology menu for for NovaSeq 6000 System, which the company says offers high-throughput testing for liquid biopsy will be presented in another workshop, one of several hosted by the sequencing giant.

POC: Point of care has transitioned to molecular in the last five years; corporate workshops on this topic include Quidel’s on POC testing for influenza, and Roche’s look at centralization and decentralization trends in diagnostic testing.

Carbapenem Resistance: (CRE) or carbapenemase-producing Enterobacteriaceae (CPE) are Gram-negative bacteria that are resistant to the carbapenem class of antibiotics, considered the drugs of last resort for such infections. Meredian Bioscience will hosting a seminar on “Carbapenem Resistance Solutions for a Clear and Present Public Health Threat”    The company’s Revogene Carba C assay provides healthcare systems with a diagnostic solution to enable early detection and management of CRE.

LabPulse.com and Kalorama Information will be covering the meeting and providing highlights of important vendor and scientific announcements.