Quidel Corporation, a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic systems, announced that it has received marketing clearance and CLIA waiver by the United States Food and Drug Administration (FDA) for its Sofia Strep A+ Fluorescent Immunoassay (FIA) for the rapid detection of infections by Group A Streptococcus bacteria. These bacteria are the most common cause of bacterial pharyngitis and can also cause rheumatic fever and other potentially serious illnesses.
Sofia is the brand name for Quidel's next-generation, immunoassay system. The Sofia Analyzer and Sofia Strep A+ FIA combine unique immunofluorescence chemistry, advanced lateral flow technology, and failure alert and fail-safe systems designed to ensure reliable, objective, highly accurate, diagnostic results within five (5) minutes of application of the patient's specimen.
The linked-FDA clearance and CLIA waiver represent the first such achievement of any manufacturer under the FDA's new Dual Submission Program. This program requires a Pre-submission, and allows for simultaneous review of the 510(k) and CLIA waiver applications, substantially reducing the time and effort required for the FDA's review of 510(k) and CLIA waiver submissions that previously required two independent sequential submissions. Successful passage through the Dual Submission Program thus allows the diagnostic industry to pursue its commercial goals sooner, while also more quickly bringing new products to the marketplace where they can serve both physicians and patients.
The CLIA waiver designation for the Sofia Strep A+ FIA allows Quidel to sell the assay to all CLIA categories of laboratories in the United States, including the CLIA-waived segment of the market that is comprised of approximately 30,000 physician offices laboratories and 5,000 hospital emergency departments. It is anticipated that the clearance and CLIA waiver of the Sofia Strep A + FIA will further expand the placement of new Sofia instruments -- a process that has accelerated throughout 2014.
"We are pleased and very proud to receive the first joint clearance and CLIA waiver designation under the FDA's new Dual Submission Program. We can now provide our CLIA-waived customers with a highly accurate, quick and easy-to-use solution for the diagnosis of Strep A infections in our best-in-class Sofia format," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Our customers love the Sofia platform, and because Strep A is our highest-volume product, we believe that our Sofia Strep A+ FIA has the potential to increase Sofia system installations and utilization well into 2015."
The Sofia Analyzer was 510(k) cleared in October of 2011, and Quidel's first Sofia FIA, the Sofia Influenza A+B FIA, received Clinical Laboratory Improvement Amendments (CLIA) waiver by the FDA in April of 2012. In addition to the Sofia Influenza and Sofia Strep A FIAs, Quidel also markets the CLIA-waived Sofia Respiratory Syncytial Virus (RSV) FIA and the Sofia hCG FIA. Quidel now provides a broad spectrum of FDA-cleared Strep A diagnostic assays that cover the full spectrum of market needs for this pathogen, including two assays on the Sofia platform (one CLIA-waived), three different assays on the QuickVue platform (two CLIA-waived), and two new molecular assays -- AmpliVue Strep A Assay and Lyra Direct Strep Assay (for Streptococcus pathogens of Groups A and C&G).
Sofia is the brand name for Quidel's next-generation, immunoassay system. The Sofia Analyzer and Sofia Strep A+ FIA combine unique immunofluorescence chemistry, advanced lateral flow technology, and failure alert and fail-safe systems designed to ensure reliable, objective, highly accurate, diagnostic results within five (5) minutes of application of the patient's specimen.
The linked-FDA clearance and CLIA waiver represent the first such achievement of any manufacturer under the FDA's new Dual Submission Program. This program requires a Pre-submission, and allows for simultaneous review of the 510(k) and CLIA waiver applications, substantially reducing the time and effort required for the FDA's review of 510(k) and CLIA waiver submissions that previously required two independent sequential submissions. Successful passage through the Dual Submission Program thus allows the diagnostic industry to pursue its commercial goals sooner, while also more quickly bringing new products to the marketplace where they can serve both physicians and patients.
The CLIA waiver designation for the Sofia Strep A+ FIA allows Quidel to sell the assay to all CLIA categories of laboratories in the United States, including the CLIA-waived segment of the market that is comprised of approximately 30,000 physician offices laboratories and 5,000 hospital emergency departments. It is anticipated that the clearance and CLIA waiver of the Sofia Strep A + FIA will further expand the placement of new Sofia instruments -- a process that has accelerated throughout 2014.
"We are pleased and very proud to receive the first joint clearance and CLIA waiver designation under the FDA's new Dual Submission Program. We can now provide our CLIA-waived customers with a highly accurate, quick and easy-to-use solution for the diagnosis of Strep A infections in our best-in-class Sofia format," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Our customers love the Sofia platform, and because Strep A is our highest-volume product, we believe that our Sofia Strep A+ FIA has the potential to increase Sofia system installations and utilization well into 2015."
The Sofia Analyzer was 510(k) cleared in October of 2011, and Quidel's first Sofia FIA, the Sofia Influenza A+B FIA, received Clinical Laboratory Improvement Amendments (CLIA) waiver by the FDA in April of 2012. In addition to the Sofia Influenza and Sofia Strep A FIAs, Quidel also markets the CLIA-waived Sofia Respiratory Syncytial Virus (RSV) FIA and the Sofia hCG FIA. Quidel now provides a broad spectrum of FDA-cleared Strep A diagnostic assays that cover the full spectrum of market needs for this pathogen, including two assays on the Sofia platform (one CLIA-waived), three different assays on the QuickVue platform (two CLIA-waived), and two new molecular assays -- AmpliVue Strep A Assay and Lyra Direct Strep Assay (for Streptococcus pathogens of Groups A and C&G).