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Quidel Sofia 2 Lyme Test FDA Cleared, CLIA Waived

NEW YORK (360Dx) – A test from Quidel to detect antibodies to the bacterial pathogen that causes Lyme disease has been cleared and CLIA waived by the US Food and Drug Administration.

Called Sofia 2 Lyme FIA, the test is a fluorescent immunoassay for human IgM and IgG antibodies to Borrelia burgdorferi that runs on the firm's Sofia 2 immunoassay reader. A test for B. burgdorferi on the original Quidel Sofia instrument, called Sofia Lyme FIA, was granted 510(k) clearance last year, while a moderately complex Sofia 2 Lyme test requiring venipuncture blood samples was cleared by the FDA earlier this year.

Guidelines from the Infectious Diseases Society of America Detecting suggest that detecting and treating of Lyme disease early can help prevent progression. The Sofia 2 system can produce results in as little as three minutes and the Sofia 2 Lyme FIA runs using a finger-stick whole-blood specimen, the firm said.

The next-generation Sofia 2 instrument has a smaller footprint than the legacy Sofia instrument, as well as wireless connectivity and a barcode scanner, and it comes connected to Quidel's data management system, Virena, which provides users near real-time aggregated, de-identified testing data.

CLIA waiver for the Sofia 2 Lyme FIA "markedly expands the available market for the Sofia 2 test system," the firm said in a statement, allowing it to be run in physician offices, as well hospitals, medical centers, smaller clinics, and alternate sites like urgent care centers, free standing emergency departments, and retail clinics.

"We expect that this new product introduction will increase the value of our Sofia 2 platform, and could create incremental instrument placement opportunities in traditional healthcare institutions that are closer to the patient, as well as in the rapidly growing alternate site segment of point of care," said Douglas Bryant, Quidel's president and CEO.

The test "will allow healthcare workers to generate a result in a single office visit, accelerating the time to diagnosis and potential treatment of Lyme Disease for the patient," Bryant said, noting that results for a typical send-out test take days.