Quest Diagnostics said yesterday that it has received 510(k) clearance from the US Food and Drug Administration for its Focus Diagnostics Simplexa Flu A/B and RSV test on the 3M Integrated Cycler.
Quest and Focus had been anticipating marketing approval: In August, a Focus official indicated that the company expected to receive the CE Mark for the Flu A/B and RSV test in subsequent weeks; and that it had submitted the test for FDA approval (PCR Insider, 8/26/10).
This week, a Quest spokesperson confirmed that the Simplexa Flu A/B and RSV test also received CE Marking earlier this quarter, allowing Quest and Focus to market the diagnostic in European countries recognizing the CE Mark.
The newly approved real-time PCR-based test is intended as an aid in detecting and discriminating influenza A, influenza B, and respiratory syncytial virus infections from a patient's nasal or nasopharyngeal specimens.
Quest said that results of a clinical study presented to the FDA in its 510(k) filing indicated that the Simplexa test performed comparably to predicate devices in detecting the target viruses in patient specimens. The company also said that it is the first molecular test that does not require confirmation of results using additional methods, such as virus culture.
The Simplexa Flu A/B and RSV test is the second test from Quest's Focus Diagnostics business to receive FDA approval. In May, the Simplexa influenza A H1N1 (2009) test for the 3M Integrated Cycler was the first commercial RT-PCR test to receive FDA clearance for detecting and differentiating 2009 H1N1 flu from other flu viruses.
Focus Diagnostics and 3M in early 2009 inked an exclusive distribution agreement to couple molecular diagnostic kits developed by Focus with 3M's Integrated Cycler platform under the Simplexa name and target customers at hospital laboratories.
The 3M Integrated Cycler is a benchtop instrument featuring a disc-shaped consumable cartridge that can process up to 96 samples in a 30- to 75-minute run depending on the analyte.
Currently, both the Simplexa Flu A/B and RSV and H1N1 flu test are designated for use in high-complexity laboratories under the Clinical Laboratory Improvement Amendments act. Quest and Focus have said that they are working with 3M to develop moderate-complexity versions of both tests.