FDA Downclassifies Multiplex Nucleic Acid Assays
This article was originally published in The Gray Sheet
FDA has decided to relax its classification of multiplex nucleic acid assays to detect microorganisms and resistance markers in the blood but with special controls to mitigate concerns with potential to misinterpret test results.
You may also be interested in...
An FDA final guidance released Aug. 27 on highly multiplexed microbiological in vitro nucleic-acid based diagnostics recommends studies on both the analytical and clinical performance of the devices.
New assays and devices on the market include Roche’s cytomegalovirus viral load test, Nanosphere’s infectious disease assay.
Phase III data earns a breakthrough therapy designation for Resverlogix’ apabetalone; previous companies to follow that strategy swiftly advance to NDA submission, as seen with Novartis’ capmatinib and Seattle Genetics’ tucatinib.