Although the FDA forced 23andMe to stop offering medical analysis of raw genetic material (taken from spit samples), the company plans to use its extensive database with more than 900,000 genetic samples as the foundation for genetics-based biopharmaceutical R&D. 23andMe is leveraging a technology platform that they have been relying upon and augmenting since the company started offering genetic analysis services roughly six years ago.
Despite the fact that 23andMe was forced to stop offering genetic analysis in the absence of formal FDA marketing authorization, the company has progressed by leaps and bounds in the last 18 months, including the FDA approval of its carrier-status test for Bloom Syndrome. Approval of this test was underscored by a great deal of contact with the FDA, which has made the company more knowledgeable about navigating regulatory pathways.
Most important for this process is 23andMe's extensive 900,000 sample genetic database, as well as ongoing research that the company has been doing in the background, looking at everything from genetic proclivities towards certain diseases, to response to drugs, to carrier status and other genetic associations. In addition, 23andMe is collaborating with researchers from Genetech and Pfizer on research focused on disease states, such as Parkinson's disease and irritable bowel syndrome.
In fact, this company's dedication to research is longstanding. Customers are opt in to be part of research, per the company's web site, which explains that a customer who consents to research supports 230 studies. The opt-in level has been strong, and with the support of a growing, world-class research team, 23andMe is using its raw materials—spit samples—to throw its hat into the ring as yet another biotech company moving into biopharmaceutical R&D. If the last six years are any guide, 23andMe has a good shot of contributing to a genetics-based therapeutic breakthrough.
Richard Scheller, formerly of Genentech, has been named Chief Science Officer and Head of Therapeutics of the company.
- Written by Nicole Gray
Here are the biggest stories in the healthcare industry this week:
The cybercriminals used employee e-mail accounts to obtain patient data.
The new model will have four payment systems and two risk tracks, including one that is "essentially near 100% risk."
The hospital's nurses have asked the public health department to investigate.
Theranos is offers a full spectrum of lab tests with blood sample sizes of only a few drops—at 50% below Medicare rates.
The hospital operator is placing the blame on onerous conditions set by AG Kamala Harris, according to the Daughters CEO.
And here's the tweets we were reading:
I’m still getting pitches that mention the “iWatch."— Farhad Manjoo (@fmanjoo) March 10, 2015
29% of renewing ACA enrollees switched plans. That suggests they are very price conscious, and it keeps competitive pressure on insurers.— Larry Levitt (@larry_levitt) March 10, 2015