Consumer genomics company Ancestry recently received two FDA 510(k)s – one for an in vitro molecular test that detects genomic variants tied to potential disease risk, and another for a saliva-based DNA specimen-collection kit.
Both of these submissions were received by the FDA in October of last year, which officially cleared them on August 13, according to the agency's 510(k) database.
Each was...
23andMe announced this morning that it has received a 510(k) clearance from the FDA that allows its direct-to-consumer personal pharmacogenetics report to guide use of two treatments without the need for confirmatory testing.
WHAT HAPPENED
This action updates a De Novo approval granted to the consumer genomics company in late 2018. That decision allowed 23andMe to market a test for one of 33...
23andMe has laid off 100 employees across its consumer business, the genomics company confirmed to MobiHealthNews.
This news come amidst disappointing sales numbers, according to CNBC, which first reported the story. In an interview with CNBC’s Chrissy Farr, 23andMe CEO Anne Wojcicki discussed potential factors contributing to what she sees as a market cooldown, top of the list being customers...
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...
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...
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...
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...
