CLN Article

News From the FDA

FDA Clears Diazyme's Vitamin D Assay

Diazyme's new 25-Hydroxy Vitamin D assay received FDA 510(k) clearance. The assay measures total true 25-hydroxy vitamin D levels (D2 + D3 levels) in both serum and plasma samples and fully automates removal of non-specific protein binding and cross reactivity to ensure accuracy. Able to provide results in less than 2 hours, labs can run the assays manually or on fully-automated microtiter plate readers.

FDA Grants Cepheid Clearance for CT/NG Test

Cepheid received clearance from FDA for the Xpert CT/NG assay, a qualitative in vitro molecular diagnostic test for detecting and differentiating Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). Designed to run on Cepheid's GeneXpert Systems, Xpert CT/NG reduces false-positive results by including more than one genetic target, as well as a sample adequacy control. Xpert CT/NG also provides results in less than 90 minutes, making it the first test to enable same-day consultation and treatment for CT and NG, the two most common sexually transmitted bacterial infections in the U.S. Same-day test results could help minimize complications that arise due to delayed treatment and improve management of patients who wouldn't normally return for treatment after initially presenting for testing.

FDA Partners with Medical Device Industry

FDA has formed a research partnership with the nonprofit Medical Device Innovation Consortium to speed up and improve the process of bringing new medical devices to the marketplace. Medical device makers involved in the consortium include Medtronic, Boston Scientific, Becton Dickinson, Abiomed, and Cyberonics. FDA believes this collaboration will boost investment in regulatory science research and lead to the development of new and better methods for the evaluation of devices. This move comes at a time when the medical device industry has been pressuring FDA to expedite the review of devices, while advocacy groups argue the agency is not doing enough to protect consumers.

Nanosphere Receives Clearance for C. difficile Test

FDA granted Nanosphere clearance for its C. difficile test designed to run on the automated sample-to-result Verigene System. The test detects the toxin A and B gene sequences of C. difficile and identifies the hypervirulent PCR ribotype 027 strain associated with increased severity of disease. It also automates the steps of bacterial DNA extraction, amplification, hybridization, and target detection, allowing clinicians to obtain results in 2 hours. The clearance of this test expands Nanosphere's portfolio of infectious diseases assays.

Quidel Receives FDA Nod for C. difficile Test

FDA cleared Quidel's AmpliVue C. difficile assay, a non-instrumented molecular diagnostic test that detects toxigenic Clostridium difficile bacterial DNA. The new assay detects C. difficile using a hand-held, fully-contained cassette that combines isothermal helicase-dependent amplification (HDA) with Quidel's lateral flow detection technology.