23andMe nabbed FDA clearance to market its genetic carrier test directly to consumers, a big win for the company as it continues to get back in the agency's good graces and expand the reach for its genetic tests.
23andMe scored FDA clearance to market its direct-to-consumer genetic carrier test for Bloom syndrome, a crucial win for the company as it continues to make good with the agency and expand the reach for its genetic tests.
Days after unveiling a $60 million deal with Genentech, personal genomics pioneer 23andMe struck a new database-driven collaboration with Pfizer. There is even talk of a possible resolution with the FDA in 2015.
23andMe's strategy of selling its database of genetic data to Big Pharma companies continues to bear fruit. The Google-backed company is sharing data about the DNA of 650,000 individuals with Pfizer to help that company in its R&D efforts.
Genentech has given 23andMe a major boost. The big biotech has reportedly paid $10 million upfront and agreed to $50 million in milestones to access 23andMe's database for target discovery of new drugs for Parkinson's disease.
Consumer-oriented genetic testing company 23andMe's up to $60 million partnership to provide Big Pharma company Genentech with access to information on about 3,000 Parkinson's patients illustrates the value of diagnostic companies' genetic information.
23andMe has found regulators in the United Kingdom more amenable to its personal genomics service than the U.S. FDA. The U.K. Medicines and Healthcare Products Regulatory Agency has given cautious backing to the company's spit test, which has a CE mark clearing it for sale in Europe.
In a week during which 23andMe showed results from a clutch of its research programs at the American Society of Human Genetics annual meeting, it also tasked an industry veteran with winning new partnerships.
Genetic testing company 23andMe--famous for getting on the bad side of the FDA--is reversing a planned policy that would automatically opt in customers to its close relatives program, which meant that by sending a saliva sample in for DNA analysis they could discover an unknown relative out of the blue.
Observers tipped the arrival of Apple's long-awaited Watch to bring the worlds of health and tech closer than ever, but this week's announcement was notably light on medical uses. The failure to even mention HealthKit in the presentation has sparked discussion of Silicon Valley's wariness of healthcare regulators in the wake of 23andMe's run-in with the FDA.