Major Public Database to Fuel Personalized Medicine

There has been much coverage of personalized medicine in the press in recent months, but many questions still remain. To help answer some of those questions and help forge new territory, the U.S. government announced this week that it is putting aside $55 million to create a public database — the Precision Medicine Cohort — with health information on an expected one million volunteers. 

Sign up will most likely begin in 2016 for volunteers, who will contribute health data over many years to help improve health outcomes and spur the development of new treatments. It is also hoped that the data will provide better preventive care and other treatments. (You can learn more about the Precision Medicine Cohort here.)

Putting regulation in place

In anticipation of the new database, the government is also looking to put into place regulations that will cover the fast-growing field of genetic testing. Earlier this week, the FDA issued a draft of guidance documents that treat questions on next-generation sequencing-based testing. Two separate documents treat different areas, with one looking at recommendations for designing, developing, and validating next-generation sequencing-based tests, and another describing how developers of treatments may rely on and accurately use public genome databases to support clinical claims.