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FDA Clears Lyme Test on Quidel's Sofia Platform

NEW YORK (GenomeWeb) – The US Food and Drug Administration has granted 510(k) clearance for a Lyme disease test on Quidel's Sofia platform, the company announced today.

The Sofia Lyme FIA is the first assay to provide differentiated results for both IgM and IgG antibodies against Borrelia burgdorferi, the microorganism transmitted by tick bites, on a single test, Quidel noted in a statement.

The Sofia analyzer and Sofia Lyme FIA use immunofluorescence chemistry and lateral flow technology to provide results within 10 minutes of application of patient serum or plasma. Detecting and treating of Lyme disease early can help prevent progression, according to guidelines from the Infectious Diseases Society of America.

Quidel is "now able to detect the microorganism associated with Lyme disease more rapidly in near-patient settings," the firm's CEO, Douglas Bryant, said. "This is another example of our ability to provide simple, cost-effective solutions for physician offices and hospitals that previously had to wait several days for send-out Lyme results," he added.

In a research note, Raymond James analyst Nicholas Jansen said that the Lyme test "represents a truly new and non-cannibalistic test for a market that could prove sizeable over time." He added that the assay has not yet been CLIA-waived, and "the eventual true use case [is] likely to be targeted at the point of care."