After First Approval of a Rapid Molecular Test, Expect More

According to Kalorama Information (New York, NY, USA), the first CLIA-waiver approval for broad use of a rapid molecular diagnostic test for influenza, from Alere (Waltham, MA, USA), demonstrates the potential for the molecular point-of-care (POC) sector predicted in Kalorama’s 2014 report.

Alere recently announced that the US Food and Drug Administration (FDA) granted the Clinical Laboratory Improvement Amendments (CLIA) waiver for its Alere i Influenza A & B test, allowing for broad use by healthcare providers ranging from hospitals to physician offices and other healthcare settings. It is currently the only clinical molecular test available to detect and differentiate influenza A and B virus in less than 15 minutes.

Kalorama predicted a trend of such decentralized testing approaches in its report “The Market and Potential for Molecular Point of Care Diagnostics.” “Kalorama had indicated last year that POC MDx technologies would hit market near-term, and now this has been realized,” said Bruce Carlson, publisher of Kalorama Information, “There are dozens of other companies that are also working on molecular POC tests, so I’d expect to see more approvals and a competitive marketplace.”

The Alere i test was cleared by the FDA in June 2014 and made available in September 2014 for health facilities licensed to conduct tests of moderate complexity under the CLIA program. Alere said that unlike PCR testing, their proprietary isothermal nucleic acid amplification technology (iNAT) does not require lengthy and complex thermo cycling or even DNA purification, and can therefore deliver PCR-caliber results faster. Clinical performance of Alere i Influenza A & B was established in a multicenter study conducted in the US, in which 630 nasal swab specimens were evaluated with Alere i and compared to an FDA-cleared Real-Time PCR (RT-PCR) assay. Additional disease tests on the Alere i platform are currently in development.

“Now that the first molecular POC has been CLIA-waived, it’s a question of whose test will be next,” said Mr. Carlson, “There are market opportunities in HIV, warfarin sensitivity, sepsis, and other areas where actionable results matter.” Kalorama’s report details these areas and the companies that have products in development. It also provides insight into the potential market for these products, and discusses important platforms and the status of products, reviews deals made, and profiles relevant companies.

Related Links:
Kalorama Information
Report: Market and Potential for Molecular Point of Care Diagnostics 
Alere