Sofia Lyme FIA is FDA 510(k) approved to detect human Borrelia burgdorferi (Lyme disease)- Quidel Corporation.

Quidel Corporation (a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced hat it has received 510(k) clearance from the FDA to market its Sofia Lyme FIA to be used with the Sofia 2 Fluorescent IgM and IgG antibodies to Immunoassay Analyzer for the rapid differential detection of human 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.

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 the ability of Quidel 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.