Quidel Receives FDA Clearance and CLIA Waiver for Its Point-of-Care Sofia 2 Instrument for Use with

Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today it has received 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the FDA for its Sofia Strep A+ Fluorescent Immunoassay (FIA) to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid detection of infections by Group A Streptococcus bacteria. These bacteria are one of the more common causes of acute upper respiratory tract infection.

Sofia 2 is Quidel’s next-generation version of its best-selling Sofia instrumented immunoassay diagnostic solution that addresses the specific testing needs of the decentralized point-of-care (POC) market. 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 5 minutes.

Sofia 2 integrates a barcode scanner and wireless connectivity 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.

The Sofia Strep A+ assay employs advanced lateral flow and immunofluorescence technologies to provide enhanced clinical sensitivity for Group A Streptococcus, one of the more serious respiratory diseases in children and seniors. These technologies help ensure a reliable, objective, rapid, and accurate diagnostic result. Early diagnosis and treatment of Group A Streptococcal pharyngitis has been shown to reduce the severity of symptoms and serious complications such as rheumatic fever and glomerulonephritis.^1,2

"With the clearance of Sofia Strep A+, Sofia 2 now provides clinicians at the point-of-care with a powerful diagnostic tool that quickly and accurately diagnoses three of the more common respiratory diseases: Influenza A+B, RSV and Strep A. We believe that the Sofia 2 solution is a perfect fit for the specific needs of the point-of-care space, especially as we continue to develop and add incremental assays to the Sofia 2 ecosystem," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Sofia 2 will build on the successful legacy of our original Sofia flagship product by expanding our instrument placements into the smaller, lower volume physician offices as well as the higher volume health systems, while also significantly growing our Virena wireless coverage throughout the country."

Sofia Strep A+ is the third CLIA-waived assay available on the Sofia 2 system. Sofia 2 is CLIA-waived for use with the Sofia Influenza A+B assay as well as the Sofia RSV assay, for the detection of Respiratory Syncytial Virus.