Big Step For Gentris: Genomics Firm Submits Tests For FDA Approval

RESEARCH TRIANGLE PARK, N.C. — Startup

Gentris

, which is focused on genomics research and the potential of individualized medicine, has taken a major step forward in the attempt to commercialize its technology.

Gentris has submitted information based on clinical tests seeking Food and Drug Administration approval for a series of genetics-based tests. The tests are already being used in research environments.

The FDA is expected to act upon Gentris’ tests within the next 90 days. If the FDA approves the tests, Gentris can then market them commercially.

Gentris’ submission is for tests centered on the so-called CYP2D6 gene, which is a liver enzyme that metabolizes some 20 percent of all commonly prescribed drugs, according to Gentris. Genetic variations in the gene can lead to unexpected reactions in some 7 percent of patients. While tests exist that can detect variations in the gene, Gentris said its testing technology includes DNA-based controls that make results more reliable.

Gentris’ submission to the FDA is based on trials at three different sites.

Gentris’ name for its product is GentriSure. It is also researching products for other genes.