October 31, 2018
Yesterday afternoon the FDA announced that it would permit 23andMe to market its Personal Genome Service Pharmacogenetic Reports test. The test offers consumers information on whether they posses one of 33 variants across multiple genes that could impact their body’s ability to metabolize certain medications.
The purpose of this test is to inform patients and encourage them to more thoroughly...
August 24, 2018
23andMe has emailed developers a warning that an API permitting use of anonymized customer datasets for third-party app development will be shut down in approximately two weeks, CNBC reports.
While the raw data will remain available to clinical research partners such as GlaxoSmithKline, which invested $300 million this year to gain access to the genetic testing startup’s DNA database for drug...
August 1, 2018
A group of consumer genetic and personal genomic testing companies have released a set of best practices for handling consumers’ personal genetic data.
Designed to ensure privacy and promote transparency, the guidelines include a requirement for separate express consent before a company can transfer genetic data to a third party, such as an insurer or employer.
“Supporting strong and transparent...
November 7, 2017
FDA Commissioner Scott Gottlieb announced today that the agency intends to make a major change to its regulatory process around direct-to-consumer genetic health risk (GHR) tests. Specifically, the agency is creating a framework that will allow companies to bypass premarket certification for individual tests once they submit to a one-time review of their processes, an approach reminiscent of the...