The Food and Drug Administration has made public its plans to regulate some genetic diagnostic tests developed in laboratories and used to guide treatment decisions for patients.
FDA plans to publish a draft guidance to guide laboratories through the process of notifying the FDA that they are developing an/or using lab-developed tests, informing the FDA about said tests and complying with medical device reporting requirements, according to a news release.
This is a new area of regulation for the FDA and could cover more than 11,000 tests developed by about 2,000 different laboratories, according to a report from Forbes.
Some of the new regulatory standards will be based on risk — tests that explicitly guide treatment decisions will come under stricter scrutiny than those that are merely advisory or informational. This extra regulation could make an impact in fields such as oncology, for which genetic testing to determine treatment has become commonplace, according to the report.
The July 31 announcement comes hot on the heels of Google's announcement of a GoogleX pilot project, named Baseline Study, collecting genetic material from 175 individuals to determine genetic "biomarkers" of health. Both Google's research and the FDA's regulatory involvement indicate the increasing functional use of genetics in medicine, which is a relatively unexplored and unregulated frontier.
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