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.
Time reports that some experts have raised concerns about 23andMe's new direct-to-consumer pharmacogenetic tests.
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.
A $5 million NIH grant will fund CPIC's ongoing work to develop PGx guidelines and an API for incorporating them into EHRs and clinical decision support systems.
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.
Thermo Fisher Scientific says it will no longer sell machines in China's Xinjiang region, according to the Wall Street Journal.
New Scientist reports that 20 percent of human and yeast proteins are uncharacterized.
The University of Zurich's Ruedi Aebersold and his colleagues analyzed a dozen HeLa cell lines to find differences in gene expression, protein levels, and more.
In Nature this week: protein-coding variants associated with body-fat distribution, and more.