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 4,000-participant study will use a digital enrollment platform and will provide free genetic testing as well as support from doctors and genetics experts.
The Chinese government has implemented clearer regulatory guidance for genomic tests and invested in both clinical testing and research, spurring growth.
According to the Federal Register notice, after a first time FDA marketing authorization, manufacturers can commercialize new GHR tests without additional review.
