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Demand for testing has gone from a healthcare industry topic to a national crusade in weeks with the onset of COVID-19. High-throughput tests have been approved by the U.S. Food and Drug Administration (FDA) for use in the U.S. for the detection of SARS-CoV-2, the virus behind the disease. But for true intervention in doctors offices — or even airports, many see so-called “point-of-care” (POC) IVD tests as the ideal solution.  A new report on worldwide point-of-care markets from IVD market researcher Kalorama Information has been released amid the coronavirus outbreak. The report has markets for all kinds of near-patient testing — everything from self testing for glucose to rapid HIV tests to cardiac marker tests. Yet the focus in recent weeks has been on tests for COVID-19. Point-of-care tests are tests designed to be portable enough and fast enough to be useful during an one visit or in a decentralized location within a hospital or clinic.

To break a transmission chain, fast access is needed. These tools offer fast access, rather than waiting on texts or doctor’s office staff for restults. Kalorama publishes a report each year on POC markets and has just released its 2020 version: https://kaloramainformation.com/product/the-worldwide-market-for-point-of-care-poc-diagnostics-7th-edition/.

In terms of actual tests for coronavirus tests, there are no U.S. approvals at the time of writing, but products are in development. Molecular POC (mPOC) tests make the most sense because the threat is a virus and can be identified using the gold standard of reverse transcription polymerase chain reaction (RT-PCR). Point-of-care tests are currently used for flu and step tests, including systems by Abbott (ID NOW), Roche (Liat), and Cepheid (Xpert Xpress) mPOC-maker Cepheid says it is developing an automated molecular test for the qualitative detection of SARS-CoV-2. And Cepheid says it will try to utilize its tens of thousands of existing instrument placements. “By leveraging the design principles of our current Xpert Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted to provide rapid detection of current and future pandemic coronavirus strains, we are developing a test that can be applied in multiple settings where actionable patient management information is needed quickly,” the company said.

Singapore POC maker Credo Diagnostics Biomedical announced this week that it has obtained the CE mark in Europe for an assay to detect SARS-CoV-2. The test runs on the firm’s platform, called VitaPCR, and the company said it uses PCR and runs the test in 20 minutes. The system needs minimal operator training to run and involves no additional equipment, according to Credo.

The company says the VitaPCR SARS-CoV-2 Assay is now also pending Emergency Use Authorization from the FDA and Emergency Use Listing from the World Health Organization.  While not as fast as immunoassays, the mPOC systems typically use isothermal amplification to achieve much faster turnaround than the regular lab-based RT-PCR tests. This is one of their biggest strengths, along with low. The following are some additional examples of molecular diagnostic systems and assays including POC and other technologies which are available or under development:

  • Aldatu Biosciences – PANDAA qDx SARS-CoV-2
  • Becton Dickinson (BD) – BD and BioGX submitted for EUAs on BD Max platform
  • BGI/ Pathomics Health – Fluorescent RT-PCR kit (CE marked); 2019-nCoV PMseq Kit
  • Bio-Rad – standards – synthetic COVID-19 RNA transcripts and human genomic DNA
  • bioMerieux/ BioFire Defense – FilmArray, BioFire COVID-19 Test
  • Biomeme – Go Strips for  COVID-19
  • BIONEER Corporation – AccuPower 2019-nCoV
  • Caspr Biotech – Phantom 1.0 Dx, disposable test usingCRISPR
  • Cepheid – Test in development for Xpert Xpress system announced; partnership for Sherlock Biosciences’ CRISPR-based SHERLOCK (Specific High-sensitivity Enzymatic Reporter unLOCKing) engineering biology platform, to design tests to run on Cepheid’s GeneXpert systems
  • CerTest Biotec – VIASURE 2019-nCoV Real Time PCR Kit (CE mark for BD Max platform)
  • Co-Diagnostics – Logix Smart Coronavirus Disease 2019 (COVID-19) Test; single step rRT-PCR (CE mark)
  • Coyote Bioscience – Mini8 Portable Molecular Diagnostic QPCR Station (CFDA approved)
  • Credo Diagnostics Biomedical – VitaPCR platform, COVID-19 assay (CE mark)
  • Curetis/ OpGen/ BGI – RTPCR test kit for SARS-CoV2 (CE mark)
  • Diagnostics for the Real World Ltd – SAMBA II COVID-19 Test
  • GenMark – ePlex SARS-CoV-2 test; sample-to-answer system based on competitive DNA hybridization and electrochemical detection technology (RUO, with EUA submitted)
  • HiberGene – HG Swift, can use battery power, pursuing Fast Track Emergency Use in China
  • Integrated DNA Technologies (Danaher) – 2019-nCoV CDC EUA Kit
  • Jiangsu Qitian Gene Biotechnology Co., Ltd. – Fluorescent RAA Detection for 2019-nCoV
  • LabCorp – COVID-19 reverse transcription polymerase chain reaction (RT-PCR) test (EUA issued)
  • LGC Biosearch – primer and probe kits for CDC Real-Time RT-PCR Diagnostic Panel
  • MiCo Biomed Co. Ltd – VERI-QTM PCR 316 COVID-19 detection system
  • Mobidiag – Novodiag COVID-19 + InfA/B – multiplex test for coronavirus and influenza
  • Molbio – TrueLab, Truenat SARS CoV-2 – TruePrep and TrueNAT instruments
  • Mologic – battery powered point-of-need diagnostic test
  • Novacyt – qPCR (CE mark)
  • OnSiteGene – Peak V
  • Pinpoint Science – SARS-Cov-2 test in partnership with Analog Devices
  • Qiagen – QIAstat-Dx, Respiratory Panel 2019-nCoV
  • QuantuMDx – Q-POC
  • RainSure Bio – DropX-2000 Digital PCR System, RainSure COVID-19 dPCR Detection Kit
  • Randox Laboratories Ltd – Extended Coronavirus Array
  • Seegene – Allplex 2019-nCoV assay (CE mark)
  • Sentinel Diagnostics – Stat-NAT COVID-19 assay
  • SolGent – DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit (CE mark)
  • Twist Bioscience – NGS-based target capture for SARS-CoV-2 detection and screening
  • Ubiquitome – Liberty16, open mobile real time PCR system with 2-3 hour battery life

 

In addition to direct tests for SARS-CoV-2, Kalorama expects demand for flu tests to increase due to “rule-out” testing.

Right now, molecular is the focus for the current pandemic, but immunoassays also are in development. Molecular tests generally analyze the viral RNA in patient throat/nasal swabs, but there are other POC testing methods that use immunoassays to detect the patient’s COVID-19 antibodies in blood or serum. It appears there are roles for both mPOC and immunoassay POC tests as there are trade-offs between the two. Immunoassays generally suffer from a high rate of false negatives (low sensitivity), with some rare exceptions. Nonetheless, immunoassays can have comparable speci􀂦city and a varying combination of lower cost, faster turnaround, greater portability, and, thus, advantages in the context of larger-scale population surveillance, screening, and triaging of patients in outbreak situations.

About Kalorama Information

We have just published our latest report, The World Market for Biomarkers. Biomarkers are biological or biochemical molecules, genetic changes, or other characteristics that can be measured; they indicate or predict a condition, risk, or likely biological response. Biomarkers can be used for a range of diagnostic applications including predicting disease risk, diagnosis, predicting prognosis, identifying appropriate therapy for an individual, monitoring disease or for return of a disease, and other applications. These tests are extremely important, since lab test results inform 60% – 70% of all critical clinical decisions, such as whether to admit, discharge and/or initiate therapy for a patient. Biomarkers are also extremely important in the development of new drugs, as they can be used to generate data that may eventually be part of the regulatory submission package.

The biomarker market is extremely large, reflecting the large market for diagnostic tests based on these biomarkers, and also the ongoing efforts to discovery, validate, and commercialize new biomarkers. This market is fueled by factors that are supporting growth of both the research and the diagnostics markets, including:

  • Aging of the population
  • Rising rates of obesity
  • Growing number of cancer therapies
  • Longer lifespans of cancer patients
  • Advances in technology, improving our ability to analyze the increasing number of biomarkers
  • Advances in bioinformatics

In addition, market growth is being fueled by the identification, validation, and introduction of new biomarkers, and products based on these new biomarkers. These include safety and efficacy biomarkers being used in drug discovery and development, and other applications in addition to diagnostics.

The large and growing biomarker market has attracted a lot of attention, and new players are entering the market. For biomarkers that have already been commercialized and for which many diagnostic companies offer tests, this is a very competitive field. However, even for companies that have developed their own, proprietary biomarkers, this can be a very competitive market as different companies or laboratories work to convince clinicians to use their proprietary biomarker or panel for a specific disease application, rather than use a biomarker or panel offered by a competing company.

Many different technologies have been developed and are used in biomarker discovery, and also for detection and analysis of known biomarkers. These include traditional technologies, some of which have been used for decades. In addition, many new technologies developed for other applications are now being applied in this field. These include mass spectrometry and next generation DNA sequencing. Many tests performed using newer technologies are currently being done primarily as laboratory developed tests (LDTs) or by organizations performing clinical tests for pharmaceutical companies developing new drugs; however, some companies plan to eventually develop IVD test kits based on their laboratory assays. Selected examples of companies using these various technologies are discussed in this report, including key players in the market:

  • Companies Using Immunoassays for Detection and Analysis of Biomarkers
  • Companies with Immunohistochemistry Tests for Detection of Biomarkers
  • Companies Using In Situ Hybridization for Detection and Analysis of Biomarkers
  • Companies Using PCR or Other Nucleic Acid Amplification-Based Technologies for Biomarker Assays
  • Companies Analyzing Gene Signatures
  • Companies Using Microarrays to Detect and Analyze Biomarkers
  • Diagnostics Companies and Clinical Laboratories with Sequencing-Based Biomarkers
  • Companies Using Mass Spectrometry

Companies, clinical laboratories, researchers, and others do not generally purchase “biomarkers.” One exception is in settings in which companies or clinical laboratories acquired rights to use specific biomarkers for certain applications. The application may be development of reagents or assays that can be sold to researchers who are studying the biomarker, or who are using the biomarker in their research. These research applications could include using the biomarker as a safety marker, or as a surrogate marker for clinical efficacy, or a different research application. Alternatively, applications of new biomarkers may be to develop diagnostic assays that will be used in clinical setting for diagnosis, predicting prognosis, monitoring, determining the optimal therapy, or other clinical application. In addition, some biomarkers may prove valuable as potential targets for novel new therapies.

VialsIn our report, the market for biomarkers focuses on the applications of biomarkers. This includes both research and diagnostic applications of biomarkers. The potential market for biomarkers being evaluated as potential drug targets is not included in this market analysis, as that therapeutic market would be determined by the potential market for new therapies targeting the biomarker drug target. Key biomarker categories with 2019-2024 market estimates include the following:

  • Cardiac Markers [cTn, HscTn, Acute CK-MB/BNP, Others]
  • Tumor Markers [PSA, CEA, CA 125, AFP, PSA Rapid, Others]
  • Coagulation Markers [PT/INR, D-dimer]
  • Infectious Disease Markers [including Sepsis]
  • Immunological Disease [Autoimmune/Allergy]
  • Neurological Markers
  • C-Reactive Protein and Other Markers

The World Market for Biomarkers estimates the world markets for biomarkers and biomarker tests from 2014 to 2024, with 2019 as the base year, providing global biomarker market forecasts for the total biomarker market, the market by application (clinical diagnostic biomarker market, research biomarker market), and the market by geographical distribution:

  • Total Global Biomarker Market by Application, 2014 – 2024, in $Millions (Clinical Diagnostic, Research, Total)
  • Biomarker Market Segments by Application, 2014, 2019, 2024, by Share (%) (Clinical Diagnostic, Research)
  • Total Global Biomarker Market by Region 2014 – 2024, in $Millions (North America, European Union, Japan, China, India, ROW, Total)
  • Global Market Segments by Region, 2014, 2019, 2024, by Share (%) (North America, European Union, Japan, China, India, ROW)

The World Market for Biomarkers includes profiles of companies active in the discovery and/or commercialization of biomarkers. This includes companies commercializing in vitro diagnostic tests for detection and analysis of biomarkers, selected diagnostic companies commercializing diagnostic tests in their own CLIA certified laboratories for detection and analysis of biomarkers, and selected other players. The report’s focus is on companies with commercialized products and/or very advanced development programs. The diagnostics market is a highly competitive market, and there are many additional diagnostic companies that offer tests based on biomarkers discussed in this report. Companies profiled in the report range from large, multinational companies to smaller companies in or entering this market, including the following:

  • 20/20 Genesystems
  • Abacus Diagnostica
  • Abbott Laboratories
  • Act Genomics
  • Adaptive Biotechnologies
  • Admera Health
  • Agena Bioscience
  • Agendia
  • Agilent Technologies
  • Alpco
  • Ambry Genetics
  • Athena Diagnostics /Quest
  • Banyan Biomarkers
  • Beckman Coulter
  • Becton, Dickinson
  • Biofire Diagnostics/Biomerieux
  • Biohit
  • Biomérieux
  • Bio-Rad Laboratories
  • Cancer Genetics
  • Caris Life Sciences
  • Cepheid
  • Curetis
  • Exact Sciences
  • Foundation Medicine
  • Fujirebio
  • Genomic Health
  • Hologic
  • Illumina
  • Myriad Genetics
  • Neogenomics
  • Ortho-Clinical Diagnostics
  • Qiagen N.V.
  • Roche
  • Siemens Healthineers
  • Sysmex Corp.
  • Thermo Fisher Scientific
  • Ventana Medical Systems/Roche
  • Zeus Scientific

The large and growing biomarker market has attracted a lot of attention, and new players are entering the market. For biomarkers that have already been commercialized and for which many diagnostic companies offer tests, this is a very competitive field. However, even for companies that have developed their own, proprietary biomarkers, this can be a very competitive market as different companies or laboratories work to convince clinicians to use their proprietary biomarker or panel for a specific disease application, rather than use a biomarker or panel offered by a competing company.