Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market its Sofia Lyme FIA to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma specimens from patients suspected of B. burgdorferi infection. The test is intended for use with either the Sofia or Sofia 2 analyzer to aid in the diagnosis of Lyme disease.

Borrelia burgdorferi spirochetes/CDC
Borrelia burgdorferi spirochetes/CDC

Sofia 2 is Quidel’s next-generation version of its best-selling Sofia instrumented system. Sofia 2 utilizes the original Sofia’s fluorescent chemistry design while improving upon the graphical user interface and optics system to provide an accurate, automated and objective result in as few as 3 minutes. Sofia 2 also integrates wireless connectivity and its barcode scanner within a smaller footprint than the legacy Sofia instrument. The next-generation Sofia system also comes connected to Virena®, Quidel’s data management system, which provides aggregated, de-identified testing data in near real-time.

Lyme disease is the most common tickborne disease in North America and Europe. In the United States, Lyme disease is caused by the bacterium, Borrelia burgdorferi, transmitted through the bite of an infected blacklegged tick.

Patients infected with B. burgdorferi may experience symptoms associated with three stages: early localized disease, early disseminated disease, and late persistent disease. The most characteristic symptom of early localized disease is the appearance of erythema migrans (EM) on the skin. EM may also be accompanied by flu-like symptoms days or weeks after infection. In the second stage, early disseminated disease, untreated patients may begin to see neurological and rheumatological manifestations, and less commonly, dermatological, cardiac, or ophthalmological manifestations. These symptoms generally appear weeks to months after infection. If the disease continues to be left untreated, late persistent disease may also follow months or years later with continued progression of manifestations in the joints, heart, skin, and nervous system.

Early detection and treatment of Lyme disease can help resolve symptoms and prevent progression of the disease. The primary means of identifying B. burgdorferi infection is detection of the body’s IgM and IgG antibody response by way of immunoassay. Detection of IgM antibodies to B. burgdorferi is generally most significant in the earlier stages of the disease. Conversely, detection of IgG antibodies has proven to be significant for longer periods, as the antibodies may remain detectable years after infection.

“The Sofia Lyme Assay’s 510(k) clearance for use on the Sofia 2 instrument will allow healthcare workers to generate a faster result, thereby accelerating the diagnosis and potential treatment of Lyme Disease for the patient. 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,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “We expect that 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.”

The Sofia Lyme Assay was previously 510(k) cleared for use on the Sofia instrument. This new 510(k) clearance allows the assay to also be run on the Sofia 2 instrument. The Sofia Lyme Assay is the fourth 510(k) cleared Sofia test for use on the Sofia 2 system: the Sofia Influenza A+B Assay, the Sofia RSV Assay, and the Sofia Strep A+ Assay were 510(k) cleared and CLIA waived by the FDA in 2017.

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