With the world’s major health organization upping the mortality rate to 3.4%, there is increased need for a working rapid test for COVID-19 to be able to properly isolate patients and protect providers.

The World Health Organization (WHO) has raised its estimate of the mortality rate of patients infected with the novel coronavirus to 3.4% globally, up from a 2.3% death rate in previous estimates.  In a press briefing in Geneva, WHO Director-General Dr. Tedros Adhanom Ghebreyesus told reporters of the higher mortality estimate based on reports coming in from around the world, according to an article on CNBC.com.

The novel coronavirus SARS-CoV-2 causes the disease COVID-19. As of March 4, 92,943 cases of COVID-19 had been reported globally, with 3,160 deaths, Ghebreyesus noted during a mission briefing on March 4. The WHO has shipped nearly half a million sets of personal protective equipment to 27 countries and has sent “hundreds of thousands of lab tests” to countries in call regions, he said.

The higher mortality estimate for COVID-19 represents a significant escalation of the health risk posed in the event that coronavirus infections spread significantly. Concern about the coronavirus outbreak has already resulted in the cancellation or postponement of public events scheduled for March, such as the European Congress of Radiology in Vienna and the Acute Cardiovascular Care conference in Athens.

By point of comparison, the mortality rate from the seasonal influenza virus is around 0.1% in the U.S., according to published sources.

In the press briefing, WHO officials said that much of the difficulty in estimating the health impact of the novel coronavirus comes from the fact that the virus behaves differently from the flu virus, and the mechanisms by which it is transmitted aren’t fully understood, according to the CNBC report.

On the positive side, they said that in countries with “strong measures” to contain outbreaks, virus transmission can be suppressed.

Please sign up to our sister publication, www.labpulse.com for more information on this disease.

Adding a fifth “vital sign” — that is, travel history — to patient intake evaluations could go a long way toward identifying those at risk of the COVID-19 coronavirus disease and potentially slow its spread, according to a commentary published March 2 in the Annals of Internal Medicine.

A typical patient evaluation includes an assessment of temperature, heart rate, respiratory rate, and blood pressure. But in the context of COVID-19, adding travel history is key, wrote a research pair led by Dr. Trish Perl, chief of the division of infectious diseases at the University of Texas Southwestern Medical Center.

“A simple, targeted travel history can help us put symptoms of infection in context and trigger more detailed history, appropriate testing, and rapid implementation of protective measures,” explained Perl and colleague Dr. Connie Price, a professor of medicine/infectious disease at the University of Colorado.

The clinical community’s experience in dealing with severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), and Ebola point to how critical it can be to identify disease through travel history, Perl and Price noted. They cited a missed opportunity in a 2014 Ebola case.

“In Dallas, a patient presented to an emergency department in 2014 after returning from Liberia with low grade fever, abdominal pain, dizziness, nausea and headache,” the authors wrote. “The patient had Ebola. Because clinicians did not obtain the one potentially distinguishing clinical clue — a travel history — the well-being of both the patient and caregivers were compromised.”

In the face of the COVID-19 epidemic, health organizations and individual countries have attempted to control the spread of the virus via strategies such as travel and public gathering restrictions, school closures, and city quarantines, Perl and Price noted. But these measures may not be enough.

“Investigators estimated that there were almost 59,000 cases in Wuhan and 3,500 in other regions in China before the travel ban was implemented. … A recent report suggests that, because of the incubation period for COVID-19, the spectrum of symptoms, and the time during the incubation period persons may fly, 46% would be missed by airport-based screening,” they wrote. “Available data specific to COVID-19 suggest that screening and restricting travelers may have limited impact on containment.”

All members of the healthcare team need to integrate epidemiologic information such as travel history in their risk assessments in the same way they ask about tobacco exposure to assess cancer and heart disease risk, according to Perl and Price.

“They need a simple script to elicit clues for emerging infectious diseases and must be informed about current emerging pathogen threats, such as COVID-19,” the authors concluded. “Including travel history as a vital sign could serve as a warning sign that prompts protective measures.”

Stronger Than Average Threat,  Genetics Reveal 

The rise of next-generation sequencing has led to a boom of viral sequence discovery. The genus betacoronavirus is divided into four lineages (A-D) and contains a number of human viruses. Lineage B has around 200 published virus sequences and includes the severe acute respiratory syndrome coronavirus (SARS-CoV) and the newly emerging SARS-CoV-2 (previously called 2019-nCoV). It is still unknown if other viruses in this lineage have the potential to emerge in humans. Moreover, current techniques to study whether these viruses can enter human cells are technically demanding, time-consuming, and expensive.

Many viruses, including betacoronaviruses, use cell entry as a means of cross-species transmission. All coronaviruses encode a surface glycoprotein — a spike — that binds to the host-cell receptor and mediates viral entry. The host receptor for SARS-CoV-2 has been identified as angiotensin-converting enzyme 2 (ACE2). For betacoronaviruses, a single region on the spike called the receptor-binding domain (RBD) mediates this binding interaction. After binding, the host proteases cleave the spike, facilitating virus entry.

With underlying mechanisms in mind, and with the goal of overcoming testing limitations, Michael Letko, PhD, and colleagues from the NIH took a reductionist approach to studying coronavirus entry. They developed a scalable, biosafety level 2-compatible method for detecting the minimal region of coronavirus that’s essential for interacting with a host receptor.

Relying on the principle that RBDs on coronavirus spikes are capable of folding independent of the rest of the spike protein, and that they contain all of the information needed for host receptor binding, the NIH researchers tested receptor usage of all published unique RBD sequences for lineage B coronaviruses.

They found that lineage B RBDs divide into three functionally distinct clades. Only clade 1 RBDs contain all 14 residues that have been shown through crystallography to interact with human ACE2. Using synthetic biology and molecular engineering, combinations of coronaviruses were generated to test the specificity of RBDs, the importance of protease in viral entry, and whether these two processes are coupled.

The studies revealed that protease-mediated entry is receptor dependent, with ACE2 entry being lineage B clade 1 specific. However, when the spike was genetically modified in clade 2 and 3 viruses, viral entry was improved to varying degrees. This suggests that the limiting factor of viral transmission may be protease processing.

Interestingly, the RBD for SARS-CoV-2 has residues and motifs found in all three clades but uses ACE2. This may explain the human-to-human transmissibility of the virus. It contains most of the contact points with human ACE2 that are found in clade 1 and some amino acid variations that are unique to clades 2 and 3. The researchers suggest that it may be possible that SARS-CoV-2 arose from recombination between clade 1 and the other clades.

Overall, the results of the study emphasize the importance of continued surveillance of coronaviruses at the sequence and functional levels in order to better prepare for the next emerging virus.

Courtesy of LabPulse.com

March 3, 2020 — After an on-and-off courtship, Thermo Fisher Scientific announced it is set to acquire Qiagen in a deal worth $11.5 billion. The transaction will give Thermo Fisher access to Qiagen’s molecular diagnostics expertise and potentially lead to faster development of diagnostic tests.

The deal values Qiagen at 39 euros ($44) per share, which is 23% higher than its closing price on March 2.
In terms of IVD company rankings, Thermo Fisher is the fifth largest and Qiagen ranks No. 10, according to Kalorama estimates. The combined company would have $4 billion to $5 billion in IVD-related revenue.

Thermo Fisher said the deal will expand its specialty diagnostics portfolio by adding Qiagen’s capabilities in molecular diagnostics. Thermo Fisher’s strengths include next-generation sequencing (NGS) and quantitative polymerase chain reaction (qPCR) technologies, while Qiagen markets molecular diagnostics for infectious diseases. In an investor briefing on March 3, Thermo Fisher explained how the companies’ offerings are complementary (see table).

“The combined company will accelerate the development of higher-specificity, faster and more comprehensive tests that may improve patient outcomes and reduce the cost of care,” Thermo Fisher said in a statement.

Qiagen products will benefit from Thermo Fisher’s commercial and geographic reach. In 2019, Qiagen reported revenue of $1.526 billion in 2019, up by 4% after currency adjustments from 2018. The company reported a loss for the year of $41.5 million, compared with net income of $190.4 million in 2018.

Complementary diagnostic products offered by Thermo Fisher, Qiagen
Thermo Fisher Qiagen Benefits of combination
  • Allergy and autoimmunity
  • Transplant diagnostics
  • QuantiFeron-TB Gold Plus latent tuberculosis detection test
  • Increased access to a more comprehensive specialty diagnostics portfolio
  • Genetic analysis technologies (including qPCR, NGS, Sanger, and microarrays)
  • Molecular diagnostics for infectious disease (QIAsymphony)
  • Syndromic testing capability (QIAstat)
  • Companion diagnostics offering
  • Bioinformatics capabilities
  • Higher-value diagnostic insights (accuracy, speed)
  • Improved healthcare economics

Source: Thermo Fisher investor presentation.

Thermo Fisher’s interest in acquiring Qiagen had been publicized in a Bloomberg report in November, boosting Qiagen’s value to $8.3 billion. At the time, Qiagen said it was considering offers from multiple suitors and reviewing what would make the most sense strategically. However, in January, Qiagen said the options were not compelling and that all discussions regarding an acquisition had been terminated.

The deal will affect several fields, such as lab instrumentation, next-generation sequencing, and pharmaceutical research.

Qiagen has made a number of acquisitions that expanded its position in molecular diagnostics, and it includes tests in just about every facet of molecular testing: automated DNA sample processing, molecular HPV testing, companion test development, liquid biopsy, NGS automation, and, last but not least, digital PCR, commented Bruce Carlson, publisher of Kalorama Information, a sister company of LabPulse.com.

Qiagen has several deals with pharmaceutical companies in place and creates greater opportunity in personalized medicine for Thermo Fisher. Qiagen is developing a pipeline of assays for preventive screening and diagnostic profiling of diseases and the detection of biomarkers to guide precision medicine in cancer and other conditions, Carlson commented.

In terms of IVD company rankings, Thermo Fisher is the fifth largest and Qiagen ranks No. 10, according to Kalorama estimates. The combined company would have $4 billion to $5 billion in IVD-related revenue. The top four — Roche, Abbott, Danaher, and Siemens — are very large, but the new entity would be competitive and could change positions, Carlson said.

The deal is expected to close in the first half of next year.


A Harvard Business Review  article calls for molecular point of care to step in to detect #coronavirus. You’ll hear a lot of this in coming weeks, we think.  Molecular point of care is less than 10 years old but has shown promise in flu/strep, other respiratory pathogens. They are in the right place at the right time, the clinic, the CVS, they are in parts of the hospital away from the lab.

Kalorama has reports on molecular POC here .  We are in the process of updating the report too, for mid March, to encompass 2019 and early 2020 results.  Placements in clinics make mPOC a good first responder if a test can be developed and systems adjusted.  A big if, but test makers, Cepheid is one, are on the case. https://lnkd.in/ew-TsJq

The more modular the POC system the better, that is to say the coronavirus test should be a cartridge rather than require a new instrument.  Such a test would be in demand right now and with the federal government motivated, EUAs are certainly possible to get around the normal regulatory hurdles.

But it’s not just about a regulator saying yes – a test would have to be high percentages of specificity – a poor test would just add false positives and will swell caseload numbers and increase fear. https://lnkd.in/eP9C98K

Cancer diagnostics is a highly dynamic field that consists of various types of platforms. Molecular diagnostics platforms are increasingly becoming popular as they enable accurate diagnosis as well as prognosis evaluation, which are important for treatment decisions. In 2019, the market for molecular cancer diagnostics, including histology and assays, reached $1,600 million, increasing 11.5% over roughly $1,435 million in 2018. For 2020, growth is expected to remain relatively stable driving the market to $1,770 million for the year. Roche leads the market for oncology but Illumina comes in second, a testament to the increasing use of next-generation sequencing systems.  The report can be found at: https://kaloramainformation.com/product/molecular-cancer-diagnostics-market/

The potential of molecular diagnostic tools was initially recognized by onco-hematologists during the 1980s based on the observation that specific chromosomal translocations may significantly aid the diagnosis of various types of leukemia and lymphoma. Later, the emergence of user-friendly molecular methods such as PCR has opened up practical applications that helped multiple approaches for cancer diagnosis and treatments. DNA sequencing is increasingly employed in cancer molecular diagnostics. PCR is the initial step used in isolating and amplifying specific regions of the genome, known as amplicons, before moving to sequencing of these regions, which are then compared with reference sequences to identify mutations.


Expectations for molecular diagnostics in cancer include the introduction of more biofluid-based (e.g. blood, urine) samples and tests indicated for cancer detection and monitoring. However, the current market remains largely composed of tissue-based tests, companion assays, and tests for the prognosis and diagnosis of specific cancer types.

The Cancer Genome Atlas (TCGA), a large-scale collaboration initiated and supported by the National Cancer Institute (NCI) and the National Human Genome Research Institute (NHGRI), has offered significant insights by generating data across various cancer types. TCGA concluded the most elaborate cross-cancer analysis undertaken in cancer research, namely the ‘PanCancer Atlas Project’ in April 2018, which received over $300 million funding. The project included analysis of all TCGA exome data by the Multi-Center Mutation-Calling in Multiple Cancers (MC3) network that interpreted data from over 10,000 tumor samples from 33 most prevalent forms of cancers. In a related research paper published in Cell (M. H. Bailey et. al, vol 173, P371-385 published on April 5, 2018), the authors reported the identification of 299 cancer driver genes by analyzing PanCancer data by applying PanSoftware. There are only a few targeted cancer therapies available today but over 800 oncology drugs are in development, many of which are designed to target specific mutations. With the emergence of new targeted therapies, there is a growing need for new companion diagnostic tests.

Rapid uptake of NGS is expected to have significant influence on cancer diagnostics and cancer management. NGS allows comprehensive description of germ-line DNA, analysis of somatic mutations, RNA profiles of naturally occurring tumors, etc. However, clinical integration of these advancements is expected to take a while. Even the integration of straightforward assays such as EGFR mutation or BRCA1/2 took several years and still many related issues are being studied. Hence, clinical medicine may not benefit significantly from the increasing numbers of novel candidate markers immediately due to the long time needed for clinical validation of molecular cancer diagnostics methods. Still, the demand for single gene genomics is expected to grow in cancer diagnostics, mainly in advanced markets such as the USA.

Promising innovation is evident in other relatively established markets as well, such as PCR and ISH. For instance, PCR-based molecular cancer diagnostics segment is being revolutionized by high-sensitivity technologies such as emulsion PCR including digital droplet PCR (ddPCR) and advanced separation reagents. ISH-based cancer assays are covered under the molecular histology application in the report.

There are several growth opportunities in the molecular cancer diagnostics market including:
• Global market to experience this strong level growth through the next five years.
• Increasing use of NGS technologies and liquid biopsy methods; reduction in PCR-based testing in developed markets
• Asia fastest growing market.
• Latin America continues to gain momentum but still slower than global average
• United States will remain largest market

Kalorama’s report Molecular Cancer Diagnostics reviews the current makeup of the molecular diagnostics market in cancer including its notable products and geographical segmentation. The report also reviews expected developments such as technology and product introduction. Expectations for molecular diagnostics in cancer include the introduction of more biofluid-based (e.g. blood, urine) samples and tests indicated for cancer detection and monitoring. However, the current market remains largely composed of tissue-based tests, companion assays, and tests for the prognosis and diagnosis of specific cancer types. Some of the most significant developments in this field that may have an impact in shaping cancer diagnostics and treatment management are assessed throughout the report. The report includes statistical information for cancers by type on a global level.

All market data pertains to the global market at the manufacturers’ level. The base year for data is 2019 with projections for 2020 and a forecasted market through 2025. Competitive analysis is provided for estimated and published data gathered for the 2019 year. The forecasted market analysis is based on product availability, cancer indications and sales of products expected to reach market by 2025, competitive trends, product marketing, cancer epidemiology, and demographic trends.

Information for this report were gathered using both primary and secondary research including comprehensive research of secondary sources such as company reports and literature; government documents and databases; research journals and reports; and general medical and business journals.

Primary research methods included telephone interviews and email correspondence with company representatives, researchers, government representatives, and physicians. These interviews were conducted with the purpose of capturing the perspectives from industry participants on the market opportunity and current trends. This was the basis of formulating forecast models and for confirming early findings related to market potential. Secondary research included billing databases and pricing charts.

Kalorama’s report is available at: https://kaloramainformation.com/product/molecular-cancer-diagnostics-market/

The global market for clinical laboratory services is estimated at $121.5 billion for 2019.  This is up 2.9% from the estimated value in 2010 of $93.9 billion, according to a new Kalorama Information report.  (https://kaloramainformation.com/product/clinical-laboratory-services-market-5th-edition/ )

Growth is driven by  an aging population, a growing incidence of chronic diseases, but it is more than that.  The advanced laboratory testing technologies and practices that have developed command higher prices and drive revenue growth.  There are also a number of inhibitors to growth such as the growing emphasis to reduce health costs and uncertain economic conditions.

Global markets for clinical laboratory services are expected to increase at CAGR of 3.8% over the next five years, reaching a market value of $146.4 billion by 2024. Emerging economies will be a driving source of new growth while increasing laboratory revenues are expected in the primary U.S. market. The U.S. market is likely to experience continued downward pressure for pricing; however, it will be offset by an increase in volume.

The clinical laboratory market in the United States is highly competitive with more than 400 providers of lab services in operation.  The market share situation is nearly tied: Quest Diagnostics is the leading clinical laboratory service provider in the United States  in 2019.  Quest continues to focus on providing top quality service to the laboratory industry and has remained competitive through several strategic acquisitions and alliances.  Laboratory Corporation of America follows Quest, but only marginally.  The company continues to strengthen its position in the market through unique product offerings and strategic alliances.

Global markets for clinical laboratory services are expected to increase at CAGR of 3.8% over the next five years, reaching a market value of $146.4 billion by 2024.

The report found that The United States and China are the most attractive clinical laboratory markets for growth and new opportunities  Analyses comparing various metrics, including population size and growth, aging population trends, diabetes prevalence, inflation rate, GDP spending on health, and laboratory market growth trends and demand, expose the countries with the most attractiveness for current providers and new entrants alike.

The report said that test pricing is expected to be impacted by attempts by governments to control costs, such as CMS’ revised reimbursement schedules. Testing in the esoteric segment is scrutinized by payers and continues to impose limitations and ‘medical necessity’ clauses to limit payments in some areas.

The report said that the growth in genetic testing in markets outside the U.S. are increasing and producing new opportunities for market expansion. The U.S. market is more mature, and it continues to struggle with competition; however, there is some growth expected for specialty testing in the U.S. market. Testing volume is expected to increase during the 2019-2024 period as a preventative approach to healthcare drives orders.

February 3, 2020 — For years, mass spectrometry found extensive use as a valuable analytical tool in industries ranging from chemical processing to drug discovery and development. Now the technology has transitioned into the clinical lab, with the commercialization of mass spectrometry platforms for microbial identification.

In the clinical setting, mass spectrometry has gained attention as a more specific alternative to immunoassays for determining the presence of sex steroids and for use in testing for illicit or abused drug use.

From Kalorama sister publication LabPulse.com.  Sign up for breaking news and information about the IVD and laboratory market.

Mass spectrometry can reliably measure and analyze a number of analytes, including small molecules and biomolecules. After the technology gained exposure for microbial identification, it was harnessed for many clinical applications, such as for laboratory tests quantifying analytes, for diagnostic applications in infectious disease, and for detecting inborn errors of metabolism.

The market in clinical labs reached $859 million in 2018, accounting for 17% of the overall total for mass spectrometry, according to a recent report from Strategic Directions International (SDi), a sister company of LabPulse.com.

“The market has expanded robustly in a very short time, and there is plenty of room for continued innovation and growth in multiple areas over the next decade,” SDi analysts noted.

More manageable instrumentation

Traditionally, labs were performing laboratory-developed tests on mass spectrometry as opposed to tests approved by regulatory authorities and sold by diagnostics manufacturers, but this is changing with the introduction of integrated systems and platforms, according to the SDi report.

As the clinical uses for mass spectrometers increased, the instrumentation shrank in size and has become more manageable. Gone are the huge instruments with cumbersome electronics that consumed a lot of power. Many systems now have smaller footprints and are portable analytical tools that yield rapid results. This is good news for labs that have limited space for deploying equipment.

“The main advantages of mass spectrometry include speed, accuracy, and specificity,” explained Dr. David Herold, a professor of pathology at the University of California, San Diego (UCSD) School of Medicine, in an interview.

Herold believes that mass spectrometry for the clinical lab will become more widely accepted as more systems for clinical labs are commercialized. Companies that offer mass spectrometry products for labs include Sciex, BioMérieux, Bruker, and Thermo Fisher Scientific.

Currently, Thermo Fisher Scientific is marketing its Cascadion SM clinical analyzer with high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS), which is intended to meet the needs of routine clinical laboratories. At Roche, a fully integrated mass spectrometry analyzer is being developed and is expected to include a diverse test menu.

Herold indicated that clinical lab applications for mass spectrometry initially got a boost with the drugs-of-abuse problems that the military experienced in the 1970s. The technology has now advanced to the point that performing mass spectrometry on a urine specimen enables clinicians to detect adrenal cortical carcinoma about six to 12 months before imaging tests could, he explained.

Due to its ability to analyze certain small molecules in biofluids, mass spectrometry also is finding use in diagnosing inborn errors of metabolism, Herold noted. These are unusual inherited disorders in which the body cannot properly metabolize foods, leading to the buildup of toxic compounds in the body.

Other applications that have drawn mass spectrometry to the clinical lab include electrospray ionization combined with LC-MS/MS, which helped speed sample analysis. LC-MS/MS is finding use in analyzing steroids too. The technique is well-accepted in part because it is more sensitive and specific than immunoassays.

Moreover, matrix-assisted laser desorption/ionization-time of flight (MALDI-TOF) mass spectrometry has evolved into an effective clinical microbiology technique for quickly and accurately identifying cultured bacteria and fungi. Following on this model, rapid turnaround tests are also being developed for the clinical chemistry laboratory, Herold said.

Expanding test menus

While mass spectrometry in the clinical lab for the most part has been limited to single tests, eventually labs will be able to perform panels of tests, Herold said, including those involving metabolomics and proteomics.

“It may be possible in the future to use mass spectrometry to examine someone’s metabolome and determine certain items that someone should not eat, or supplements someone should take, to help them lead healthier lives,” he theorized.

Additionally, tissue imaging by mass spectrometry is making inroads into surgical pathology, he noted. But there are challenges. A certain amount of technical knowledge is needed to support clinical testing, he explained.

“One of the drawbacks to using mass spectrometry involves the need for trained personnel,” Herold said. “Labs need personnel involved in clinical chemistry who know the right tests needed to make an accurate diagnosis.”

Identifying molds

Investigators have found that MALDI-TOF mass spectrometry can optimize the diagnosis of infections caused by filamentous fungi. Molecular techniques, such as DNA sequencing, have been the gold standard for quite some time for identifying species of fungi. These methodologies yield accurate results; however, they are expensive, require specialized equipment or trained staff to run, and are not the domain of many clinical laboratories.

In research published in the Journal of Clinical Microbiology, scientists at the Università Cattolica del Sacro Cuore in Rome indicated that MALDI-TOF mass spectrometry has application as an accurate, rapid tool for identifying common species or usual strains of filamentous fungi, including AspergillusFusarium, and dermatophytes (Sanguinetti et al, February 2017, Vol. 55:2, pp. 369-379).

In this use, MALDI-TOF mass spectrometry would compete against conventional phenotypic methods which are relatively inexpensive. However, the time needed for fungal growth is very long with phenotyping, creating a turnaround time of several days. As a result, early antifungal therapy of an infection may be somewhat speculative, and the proper therapy may be delayed.

MALDI-TOF mass spectrometry has reduced the length of turnaround time for clinical labs, although these instruments continue to rely on fungal cultures. However, in some instances, MALDI-TOF mass spectrometry is being used to analyze patient specimens directly, which avoids fungal growth requirements, according to the researchers.

The scientists proposed that MALDI-TOF-based identification techniques should be adopted into common antifungal diagnostic regimens. Utilizing the technology would be a benefit because rapidly and precisely detecting fungal pathogens can improve patient treatment and outcomes.

Such efforts show how mass spectrometry is becoming more essential in the clinical lab and will continue to find greater use as analytical and expertise issues are overcome. Toward this end, an educational nonprofit, the Association for Mass Spectrometry: Applications to the Clinical Lab (MSACL), is committed to advancing the use of mass spectrometry in the clinical laboratory through education and training. The group’s 12th annual conference will be held in Palm Springs, CA, from March 29 to April


Point-of-care has potential to reach patients who may not even be aware they are patients, as evidenced by a recent study in a major journal that documented an unusual point-of-care venue: barbershops were found to be effective locations for on-the-spot testing of black men for hemoglobin A1c (HbA1c), according to a study published January 27 in JAMA Internal Medicine. One-third of men approached agreed to point-of-care (POC) blood testing, and of those, 9% had undiagnosed diabetes.

From Kalorama’s sister publication LabPulse.com.  Sign up now for breaking news in the laboratory and IVD industries.  https://www.labpulse.com/index.aspx?sec=sup&sub=ivd&pag=dis&ItemID=800699

The study involved blood glucose screening with the A1CNow+ test (PTS Diagnostics), with results available in five minutes. Researchers approached 895 men in eight black-owned community barbershops in Brooklyn, New York City, and asked them if they were willing to get tested onsite. The sites were chosen based on whether individuals living in the neighborhoods were likely to have problems with glycemic control and reduced access to primary care.

Of the total, about one-third of the men were tested in the barbershops, and of these, 9% had undiagnosed diabetes, defined as HbA1c of at least 6.5%; in addition, 1% had HbA1c of 7.5% or higher. Another 82 men had prediabetes, defined as HbA1c between 5.7% and 6.4%.

The men who were tested had no history of diabetes and ranged in age from 22 to 65 years. Among those with undiagnosed diabetes, the median age was 41 and obesity was common, Dr. David Lee, an assistant professor in emergency medicine and population health at New York University, and colleagues reported.

The 9% rate of diabetes is much higher than the 3.6% reported for New York City residents generally, so it’s unclear whether the sample is generalizable to other areas of the U.S. Nevertheless, the study did show that an outreach program involving point-of-care testing is feasible in the setting of barbershops, which the researchers noted “are places of trust among black men.”

The test used in the study has been shown to be 93% accurate when compared with venous blood testing. In practice, POC HbA1c tests should be followed with confirmatory testing, though this was not done in the study. The researchers did provide counseling to those with prediabetes and diabetes about lifestyle modifications and advised them to seek medical care.

“Although point-of-care HbA1c testing is relatively accurate, confirmatory testing is also important,” Lee and colleagues wrote.

Kalorama Information’s report on Point of Care can be found here: https://kaloramainformation.com/product/worldwide-market-for-point-of-care-testing/


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.”