Quidel Corporation, a leading provider of diagnostic healthcare solutions, has announced that its Group B Streptococcus (GBS) test for use on the Solana molecular diagnostic instrument has gained approval from the US Food and Drug Administration (FDA). The Sofia2 analyzer's Group A Streptococcus (GAS) test has also been cleared by the FDA and has received Clinical Laboratory Improvement Amendments (CLIA) waiver from the agency. Both the GBS and GAS tests are now available for use in various healthcare settings.Quidel's GBS test has been designed to enable rapid, simple, and reliable detection of Group B Streptococcus in pregnant women, giving healthcare professionals the ability to provide precise, targeted care to their patients. GBS is a bacterial infection that affects up to 25% of pregnant women and, if left untreated, can result in severe complications for both the mother and the newborn. The FDA clearance of the Solana GBS test means that healthcare providers can now deliver faster results to patients, enabling earlier intervention where necessary, and helping to reduce the incidence of adverse outcomes.The Sofia2 Group A Strep test has been developed as a point-of-care diagnostic solution for the detection of Group A Streptococcus in patients with sore throats. Acute pharyngitis, commonly known as a sore throat, is estimated to affect over 3 million individuals in the United States every year, with the majority of cases caused by viral infections. However, bacterial infections, specifically Group A Streptococcus, need to be identified and treated appropriately to prevent rare but potentially serious complications.By providing a rapid and reliable method for the detection of Group A Streptococcus in patients with sore throats, the Sofia2 Group A Strep test has the potential to significantly improve patient outcomes and reduce healthcare costs. Furthermore, the waiver of CLIA requirements for the Sofia2 test enables healthcare professionals to implement the assay in a broader range of settings without the need for specialized laboratory equipment or personnel.We are excited to provide our customers with these important tools for the detection of Group B Streptococcus and Group A Streptococcus, said Douglas Bryant, President and CEO of Quidel Corporation. The FDA clearance of the Solana GBS test and the Sofia2 Group A Strep test is another example of our commitment to delivering high-quality diagnostic solutions that offer rapid results, accuracy, and ease of use.Quidel's Solana platform and Sofia2 analyzer are both among the most advanced and user-friendly diagnostic instruments available today. Both systems use advanced molecular diagnostics technology to deliver fast, precise results with high levels of accuracy. The Solana GBS and Sofia2 Group A Strep tests are just two examples of the many assays that can be run on these innovative systems, which are designed to improve patient outcomes and enhance the efficiency of healthcare services.The use of molecular diagnostics instruments such as the Solana and Sofia2 is becoming increasingly widespread in a wide range of healthcare settings, from hospitals and clinics to research labs and point-of-care facilities. These instruments offer fast, reliable diagnosis and monitoring of a variety of conditions, enabling healthcare professionals to deliver better care to their patients.With the addition of FDA-cleared GBS and GAS tests for the Solana and Sofia2 platforms, Quidel is expanding its range of molecular diagnostic solutions, providing clinicians and researchers with powerful new tools to improve patient outcomes. As the company continues to innovate and expand its product offerings, it is likely to remain at the forefront of the rapidly evolving molecular diagnostics market.
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