Regulatory News

The latest headlines on diagnostics regulation: FDA, CMS, and international regulatory agencies.

The assay was cleared and CLIA-waived for use on Quidel's Sofia 2 instrument for the detection of RSV using nasopharyngeal swab and nasopharyngeal aspirate/wash specimens.

The firm's real-time PCR assay for rapid detection and differentiation of novovirus genogroup I and II runs on the Aries sample-to-answer system. 

The firm said that the RealTime CMV test is the only commercially available cytomegalovirus that can amplify two select regions of the CMV genome.

The test, designed to simultaneously detect diarrhea-causing enteric viruses using DNA extracted from a stool sample, includes norovirus GI, norovirus GII, and others. 

The assay can also be used to assess a broad range of metabolic conditions, including pancreatic tumors, liver disease, acromegaly, and others.