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 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.
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.
In PLOS this week: similar variants seen in bullbogs, people with Robinow syndrome; ApoE genotypes in African-American, Puerto Rican populations; and more.
