FDA approves Simplexa Flu A/B & RSV Direct test (Focus Diagnostics) to detect Influenza

The FDA has provided 510(k) clearance and CLIA moderate-complexity categorization to the Simplexa Flu A/B & RSV Direct test, from Focus Diagnostics, on the 3M Integrated Cycler. The new test aids in the qualitative detection and differentiation of RNA of Influenza A and B viruses and respiratory syncytial virus (RSV), common causes of respiratory illness. The Simplexa Flu A/B & RSV test kit is intended for use on the 3M Cycler for the in vitro qualitative detection and differentiation of RNA of influenza A and B viruses and the respiratory syncytial virus (RSV) in nasopharyngeal swabs. The test does not require the time-consuming nucleic extraction process required by many molecular tests, and can be performed and produce results within an hour.

Moderate complexity laboratories, defined by the Clinical Laboratory Improvement Amendments (CLIA), include certain types of physician's offices, community hospitals, health clinics and integrated delivery networks. Since the test can be performed in these moderate complexity labs, patient results may be obtained readily to help speed therapeutic decisions. It was CE marked for distribution in Europe in 2011 and is now available in the United States.