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Quidel's Flu Test on Sofia 2 Clears FDA

NEW YORK (360Dx) — The US Food and Drug Administration on Friday granted 510(k) clearance to an influenza A and B immunoassay from Quidel.

The test runs on the firm's next-generation immunoassay platform, Sofia 2, which was cleared last month with an assay for respiratory syncytial virus.

Sofia 2 uses the same cartridges as the firm's standard Sofia platform, but offers higher- and lower-volume utilization, an integrated barcode reader, and an integrated router for Virena, Quidel's wireless data management and instrument surveillance system.

Quidel is also seeking CLIA waiver on the Sofia 2 platform, as previously reported. The original Sofia platform was CLIA waived in 2012 along with an influenza A+B test, and the firm has since received CLIA waiver on its Sofia tests for Strep A and RSV.

In an analyst note, Nicholas Jansen of Raymond James said the Sofia 2 flu assay will likely be a bigger driver of placements and utilization than the RSV approval, "making this news more important as we think about the near-term adoption of the technology."

Furthermore, the 510K approval demonstrates that the platform launch is growing nearer, he said, "with its lower costs, improved performance, and built-in connectivity set to help accelerate revenue growth and diversification" for Quidel in the second half of this year, as the menu expands.