The test detects 20 common viruses and bacteria that cause upper respiratory infections using the firm's high-throughput, automated MDx-3000 instrument.
The in vitro diagnostic is designed to detect whole gene segments for influenza A and B viruses and can characterize viruses as seasonal or nonseasonal.
The proposal establishes procedures and criteria for the de novo classification of medical devices that would clarify requirements for submission and review.
The US Food and Drug Administration is developing a new approach for clearing medical devices to take technological advances and modern safety and performance requirements into account.
Russian CRISPR researcher moves along with plans to ultimately alter the genes of embryos of deaf couples, though awaits regulatory approval, Nature News reports.
In PLOS this week: genome-wide association study of non-syndromic orofacial cleft subtypes, epigenetic and transcriptomic analysis of pancreatic ductal adenocarcinoma, and more.
