Tag:

23andMe

Latest Headlines

Latest Headlines

Docs: Deluge of genetic data calls for international regulatory framework

Your genetic data could be analyzed in another country, highlighting the need for an international, harmonized approach toward management of genomic data. An American company is already analyzing blood samples of Japanese women obtained from a prenatal test. 

Faced with FDA barriers, 23andMe mulls overseas expansion

Personal genetics startup 23andMe is reportedly considering expanding overseas to so it can get sales back on track despite its standoff with the FDA.

Counsyl, armed with $28M, begins big rollout of BRCA and other predictive genetic tests

California genetic testing startup Counsyl is launching BRCA and other predictive diagnostic tests. Crucially, $28 million in new Series D Financing will help kick all of this into high gear.

Four months later, 23andMe's clash with the FDA remains unresolved

In the four months since 23andMe agreed to stop selling all health-related genetic tests in the U.S. while it submits them for a formal FDA review, the California company's future has become cloudier, not clearer.  A recent blog post on its web site informed customers that executives continue to meet with regulators, but a resolution to the matter doesn't appear to be anywhere close to happening.

23andMe's genome test raises more questions, this time for ancestry results

The controversial 23andMe Personal Genome Test has demonstrated some interesting ancestry numbers, according to a blogger at  The Unz Review.

Two more angry customers sue 23andMe alleging bogus marketing

Two more customers are suing California maker of health-related genetic tests 23andMe for making bogus marketing claims. The lawsuits represent continued fallout over the FDA's assertion that the company marketed its products for years without proper regulatory approval.

FDA asserts support for consumer genetic tests despite 23andMe crackdown

The FDA backs a market that lets consumers easily gain information about their genomes and genetic risks, an agency official said, despite its move to stop 23andMe from selling its direct-to-consumer health-related genetic tests until they obtain formal regulatory approval.

23andMe capitulates, yanking all health-related gene tests pending FDA review

California's 23andMe has capitulated to the FDA, agreeing to regulators' demands to stop selling all health-related genetic tests while it submits them for a formal regulatory review.

23andMe hit with lawsuit over 'meaningless' gene tests

Amid scorn and scrutiny from the FDA, 23andMe is facing a class-action lawsuit claiming the company misled customers in selling genetic tests with no real scientific value, and plaintiffs want at least $5 million in damages.

23andMe pulls ads after FDA warning, but sales roll on

23andMe has stopped advertising its personal genetic test after a strongly worded rebuke from the FDA, Reuters reports, but the company is still selling its $99 kit despite the agency's demands.