FDA grants 510(k) approval for Solana C. difficile Assay. - Quidel Corporation

Quidel Corporation , a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced that it has received 510(k) clearance from the FDA to market its Solana C. difficile Assay for the direct, qualitative detection of the Clostridium difficile DNA in unformed stool specimens of patients suspected of having Clostridium difficile-infection (CDI).

Comment: Traditional methods for diagnosing CDI, such as glutamate dehydrogenase (GDH) or toxin antigen tests, can lack sensitivity and increase lab costs due to additional confirmation testing. In addition to significant technical expertise, cytotoxicity assays and toxigenic culture require 24 to 48 hours and 3 to 5 days, respectively, before reliable results can be obtained. The Solana C. difficile assay will now enable laboratories to offer a fast and sensitive result generated by molecular methods, without an upfront nucleic acid extraction step. The Solana C. difficile Assay is an easy-to-use, accurate, molecular diagnostic test that generates an accurate result in about 35 minutes.