Focus Diagnostics, a business of Quest Diagnostics, and 3M have announced the FDA clearance for the Simplexa flu A/B and RSV direct test on the 3M Integrated Cycler, according to a news release.
The new test is intended to help in the detection and differentiation of RNA of influenza A and B viruses and respiratory syncytial virus.
Focus Diagnostics makes the Simplexa brand of molecular test kits.
The new Simplexa test was developed with funding from the Biomedical Advanced Research and Development Authority, within the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.
The test also received CLIA moderate-complexity categorization.
"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," said Jay M. Lieberman, MD, medical director, infectious diseases, for Quest Diagnostics and Focus Diagnostics, in the release. "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 Simplexa flu A/B and RSV direct is now available in the United States. It was CE marked in 2011.
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