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FDA seeks regulation of DNA tests: medical device makers might face greater scrutiny from agency.

Publication: San Diego Business Journal
Publication Date: 29-SEP-08 		Format: Online
Delivery: Immediate Online Access
Full Article Title: FDA seeks regulation of DNA tests: medical device makers might face greater scrutiny from agency.(Deoxyribonucleic acid)(Food and Drug Administration )

Article Excerpt
Tests that allow individuals a sneak peek at their genetic predisposition for everything from baldness to breast cancer have fueled dozens of startups, including one that says it can predetermine the likelihood of a successful romantic relationship by analyzing specific genes in DNA.

But regulatory guidance has struggled to keep up with all of the advances in genomic medicine, which has advanced at a rapid rate since completion of the Human Genome Project in 2003.

The 13-year scientific research project coordinated by the Department of Energy and National Institutes of...

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