Developing a gold standard molecular test

27 January, 2015

On 6th January, the FDA made a very significant announcement: the Alere i Flu A/B test had been granted a full CLIA waiver. This is the first molecular diagnostic system to ever receive a CLIA waiver, meaning that the highly sensitive, rapid molecular test can be performed outside of CLIA-approved central laboratory settings. Alere have submitted a 510(k) application for their Strep A test on the same system and clinical trials will begin soon for an RSV test.


To fully understand the impact, though, one needs to understand what a CLIA waiver is. The Clinical Laboratory Improvement Amendments (CLIA) passed in 1988, and the program, which began in 1992, is an arm of the Centers for Medicare & Medicaid (CMS) which allows them to regulate all laboratory testing (except research) performed on humans in the U.S. The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive CMS payments, CLIA has no direct Medicare or Medicaid program responsibilities. If a test is waived under CLIA, this means that the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have determined the test to be so simple that it has insignificant risk of erroneous results. These tests are exempted from most CLIA requirements and the laboratories that perform them receive no routine inspection. On January 30, 2008, the FDA updated their CLIA waiver guidance document. The principles in it had a strong focus on traceability and performance requirements for basing accuracy testing, and strong risk analysis to base flex studies.

The Alere i test is certainly far more sensitive and specific, making it more useful to clinicians, and offering a higher pricing opportunity.

Relatively few new tests have had a 510(k) submission approved and CLIA waiver granted since January 2008 and so this underlines Alere’s technical and regulatory achievement with the Alere i. But what of the likely commercial success? Alere already owns ~50% of the Point of Care Flu testing market with their BinaxNOW Flu A/B test and the Alere i system may well cannibalize some of that market. The Alere i test is certainly far more sensitive and specific, making it more useful to clinicians, and offering a higher pricing opportunity. 

When asked about the flu test by Sagentia at last year’s JP Morgan Healthcare Conference, former CEO Ron Zwanziger speculated that the new technology could take as much as 75% of the flu market. Alere says it is very focused on rapid diagnostics this year and the VP of North American Marketing for Infectious Diseases, Keith Stauffer, recently said that the waiver under CLIA offers the opportunity to triple the market for the Alere I flu test.

We would expect further molecular diagnostic systems to be granted CLIA waivers in the coming years but for now the Alere i stands alone in its ability to produce gold standard molecular testing to non-skilled users outside of the hospital central laboratory. In October, Alere announced they would receive up to $12.9m from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) to develop diagnostic countermeasures for pandemic influenza. This will be used to develop the next generation of the molecular technology and will be intended for even more widespread use outside of the traditional healthcare system. We wait with baited breath…


Paul Wilkins

SVP Medical


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