Data from the GUIDED study will be central to commercial payor discussions, a Medicare LCD reconsideration request, and eventually expansion into the primary care market.
The genetic testing community is having a tough time deciphering FDA's intentions based on its authorization of 23andMe’s PGx test and a recent safety alert.
The agency informed the public that most PGx tests haven’t been reviewed by the agency, and they should refer to information in FDA approved product labels when using such tests.
The market authorization came with a number of caveats and special requirements that 23andMe must follow when selling its PGx tests to consumers.
The partners are advancing a comprehensive report on how the detected PGx markers impact drug response and customized reports focusing on specific types of drugs.
The funding will help the consortium continue creating and updating PGx guidelines, adding drug-gene pairings, and creating electronic tables that can be integrated within EHRs.
The system relies on the use of scannable safety code cards containing patient data, along with a web portal and automated analysis tools that deliver customized diagnostic reports.
The study, involving 322 patients from China, India, and Malaysia, is the largest randomized evaluation of warfarin PGx in Asian patients, the authors said.
The PGx decision support software that Sonic is adopting includes clinical reporting for 65 genes and can be tailored to a variety of clinical specialties.
MedTek21's software is designed to continuously analyze patient records to provide real-time personalized medication reports to physicians.