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Dx Focus: Focus Diagnostics' Simplexa Flu A/B & RSV Test


Focus Diagnostics, a subsidiary of Quest Diagnostics, said this week that the US Food and Drug Administration has granted 510(k) clearance and CLIA moderate-complexity categorization to Focus' Simplexa Flu A/B & RSV direct test on the 3M Integrated Cycler.

The new test aids in the qualitative detection and differentiation of RNA from influenza A and B viruses and respiratory syncytial virus. Focus and 3M co-developed the assay through an exclusive global collaboration, and with the support of a $5.9 million contract from the Biomedical Advanced Research and Development Authority.

The companies have also marketed several other tests under the Simplexa brand name, including the first FDA-cleared commercial test for influenza A H1N1 (2009). Simplexa Flu A/B & RSV Direct is the first moderate-complexity molecular test in the Simplexa product line. Focus received 510(k) approval for a high-complexity version of the test in December 2010 (PCR Insider, 12/2/2010).

CLIA-designated moderate complexity laboratories include certain types of physician's offices, community hospitals, health clinics, and integrated delivery networks.

The test was CE Marked for distribution in Europe last year.