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Focus Diagnostics Flu, RSV Test Kit Cleared with Additional Strains

NEW YORK (GenomeWeb) – Focus Diagnostics, a Quest Diagnostics subsidiary, has received 510(k) clearance from the US Food and Drug Administration for additional strains on its Simplexa molecular test kit for influenza and respiratory syncytial virus.

The new clearance adds 46 additional strains of influenza A and B— including 20 avian influenza A and two swine influenza virus — and seven RSV strains. The test now detects a total of 92 strains of flu and RSV, which it said in a statement is more than any other FDA-cleared molecular test kit.

The kit also detects all four influenza strains that the World Health Organization recommends be included in vaccines for the upcoming influenza season in the Northern hemisphere.

The PCR-based Simplexa Flu A/B & RSV Direct kit was cleared in 2010, received 510(k) clearance for moderate complexity under CLIA in 2012, and had additional strains cleared in 2014.

The kit is a real-time RT-PCR assay that runs on the compact, portable 3M Integrated Cycler testing platform. It uses nasopharyngeal swabs and a direct amplification disk format that eliminates nucleic acid extraction steps, providing results in about an hour.

Focus Diagnostics won a $5.9 million contract from the Biomedical Advanced Research and Development Authority to develop the initial test.

The firm also recently received clearance for a Group A Strep test on this platform and added a claim to its Simplexa Herpes Simplex Virus 1 & 2 Direct test to enable testing from genital swabs. The firm has also been developing assays for Staphylococcus aureus and methicillin-resistant S. aureus, detection and differentiation of enterovirus and parechovirus from cerebrospinal fluid, respiratory detection of Bordetella pertussis and B. parapertussis, as well as tests for Clostridium difficile, norovirus G1 and G2, and Chikungunya virus, as previously reported by GenomeWeb.