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FDA Clears Quidel Lyme Disease Immunoassay for Sofia 2

NEW YORK (360Dx) – Quidel said after the close of the market on Monday that the US Food and Drug Administration has cleared the company's Sofia Lyme FIA test to run on the Sofia 2 Fluorescent Immunoassay Analyzer.

As a result , Quidel can now market the assay on the next-generation version of the Sofia instrument in the US.

The assay can rapidly differentiate human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma specimens from patients suspected of having the B. burgdorferi infection. The test was previously cleared by the FDA for use on the Sofia platform, and is the fourth 510(k)-cleared Sofia test for use on the Sofia 2, joining the Sofia Influenza A+B assay, the Sofia RSV Assay, and the Sofia Strep A+ Assay, which were all cleared last year.

In a statement Quidel President and CEO Douglas Bryant said clearance of the Lyme test will allow healthcare workers to more quickly generate results, accelerating the diagnosis and potential treatment of patients. "We expect this new product introduction will increase the utilization of our Sofia 2 platform and could create incremental instrument placement opportunities in the near to medium term."