Molecular point-of-care diagnostic solutions 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.  The concept of molecular point of care is to mix the accessibility of POC testing with the accuracy of molecular technology. Kalorama has covered molecular point of care on a yearly or biyearly basis since 2013. Our latest report found slower system adoption, but brisk consumables sales and the continued hope of test menu expansion.

The molecular point of care segment, the focus of the report, includes only the small/ portable models and defines the molecular POC/ near-POC market as:

  • Systems that are CLIA-waived, or could soon have or potentially have the capability for running CLIA-waived tests.
  • Systems that can run moderate-complexity or high-complexity tests in a decentralized setting such as a non-laboratory area of a hospital or a physician office/ clinic visit.
  • Tests with a short waiting period for the results, making it practical and useful for POC.

This may differ from other definitions of point of care.  The mPOC systems have great sensitivity and scalability, and they won over early adopters but have had difficulty making the case for routine adoption.  As was asked at the Association for Molecular Pathology (AMP) meeting panels last year: Is the juice worth the squeeze? And there’s not a true answer yet. These systems will have to prove to gain new placements.

“Our latest report found slower system adoption, but brisk consumables sales and the continued hope of test menu expansion.”

The overall revenues estimate for this “true” mPOC segment is provided below. This segment is largely made up of tests for the flu and other respiratory diseases.    However, they are earning consumables sales from the placements they have.  As presented, the revenues for this segment are forecast to increase from $360 million to $852 million between 2019 and 2024, with a compound annual growth (CAGR) of 18.8%.

Kalorama also details another segment: more than $2 billion of “near-patient” systems that are not aimed at decentralized testing areas and require users to have technical competency.

Molecular systems need to prove marginal worthiness in the clinical setting as they have a higher cost.    Molecular tests tend to have much higher sensitivity and specificity, even 100%, but lab-based nucleic acid amplification tests were historically slower and required more expertise to run. Now with mPOC systems, the question will turn on marginal difference in sensitivity over immunoassay systems, and this will be driven by journal literature and clinical practice changes.

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.

 

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