A new report from Kalorama Information finds that molecular point-of-care (mPOC) is encountering issues with system adoption, though the recent coronavirus threat may put a spotlight on their benefits just at the time they need it. The report, “The Market and Potential for Molecular Point of Care,” finds a $360 million market for what the firm calls “true molecular point-of-care systems.” That is to say, polymerase chain reaction (PCR)-based test instruments that have a small footprint can deliver results within the space an office visit and are intended for use by untrained operators.
Molecular point-of-care diagnostic solutions such as Abbott IDNOW and Roche’s Cobas Liat offer improvements in the sensitivity and specificity of existing near-patient and rapid tests while expanding the diagnostic capabilities at points of care, such as hospital critical care units, physician offices, outpatient clinics, and community health posts in the developing world, and are used to assess conditions or admit patients. Kalorama has covered molecular point of care on a yearly or biyearly basis since 2013. Purchases spiked during severe flu events, but thus far adoption has been lower than expectations.
Could COVID-19 be an answer? An appendix in the report suggests it might be. While there are no FDA-approved molecular point of care tests for COVID-19, there are tests in development. Kalorama thinks mPOC’s portability and accuracy are a perfect match for the current demand if a test can be developed.
“The mPOC systems have great sensitivity and scalability, and they won over early adopters but have had difficulty making the case for routine adoption,” said Bruce Carlson, Publisher of Kalorama Information. “Placements compared to the possible universe of decentralized healthcare locations have not materialized. But you take a disease where everyone needs to know and they need to know for sure, and fast – if the tests can be developed that pitch can be made.”
Justification for purchases of molecular point-of-care instruments and reagents are dependent on the argument of superior sensitivity and specificity. In this regard, the findings from a January 2020 Journal of Clinical Microbiology study are welcome news. Major CLIA-waived mPOC systems were compared with immunoassay systems. Molecular had high-90s sensitivity, whereas the tested immunoassay system had high sensitivity of 80% and a sensitivity for influenza B of 67%. Not being able to establish a “true-negative” test has been a frustration of providers using rapid immunoassay tests.
“Those studies help, as does the recent novel coronavirus scare,” Carlson said. “COVID-19 is a possible game-changer because mPOC systems are more accurate than immunoassays, and it is in PCR’s wheelhouse to detect RNA mechanisms. If systems can be adjusted quickly, and you do have Cepheid talking about a cartridge-based product in development, mPOC could take off.”
Kalorama’s report is available at: https://kaloramainformation.com/product/the-market-and-future-potential-for-molecular-point-of-care/
About Kalorama Information
For more than 30 years, Kalorama Information has been a leading publisher of market research in healthcare.