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FDA Clears Focus Diagnostics' Flu Test on 3M Integrated Cycler

This article has been updated to note that the Focus test was cleared by FDA two years ago for high-complexity labs.

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has given 510(k) clearance to Focus Diagnostics' Simplexa Flu A/B & RSV Direct test, Focus and 3M announced today.

The test, which aids in the qualitative detection and differentiation of RNA of influenza A and B viruses and respiratory syncytial virus, was developed by Focus, a Quest Diagnostics business, which makes the Simplexa brand of molecular test kits, and runs on the 3M Integrated Cycler. The firms also launched the test in the US today.

The new approval is for moderate complexity under CLIA. Two years ago Focus received FDA clearance for the test for use in high-complexity laboratories.

The test, developed through a collaboration by the two firms forged in 2009, received CE marking in 2011.

The test, they said, is the first moderate-complexity molecular test from Focus' Simplexa product line and "significantly" broadens clinical access to the Simplexa/3M technology. Moderate-complexity facilities, such as doctors' offices, clinics, and health clinics, typically do not have the personnel and technology to run high-complexity molecular tests, and the Simplexa Flu A/B & RSV Direct test allows such facilities to obtain results readily, aiding in quicker treatment decisions.

"The future of influenza and all respiratory virus testing is molecular diagnostics, given its potential for high sensitivity and fast reporting of test results, which are essential for patient management," Jay Lieberman, medical director of infectious diseases for Quest Diagnostics and Focus Diagnostics, said in a statement. "The clearance and moderate complexity categorization of the Simplexa test on the 3M Integrated Cycler signifies an important step forward in expanding access to near-patient molecular testing, potentially helping clinicians to make better decisions for their patients."

The Biomedical Advanced Research and Development Authority, within the US Department of Health and Human Services, awarded a $5.9 million contract for the development of the test.