RESEARCH TRIANGLE PARK, N.C. – Gentris’ building of a successful business around genomics testing has taken a big step forward, having secured U.S. Food and Drug Administration approval for one of its diagnostic tests.

“The FDA’s approval of our GentriSure product line is an extremely important achievement for Gentris,” said Michael Murphy, chief executive officer of Gentris. “It demonstrates our ability to implement a GMP-compliant facility, as well as to navigate the regulatory process. This latest development also proves our capability to expediently manage the complexities of conducting clinical trials with our products.” he added. “We are already applying the same model to other products in our pipeline.”

GMP is a FDA mandated standard for production facilities.

The FDA approval is for six of what Gentris calls “reference controls” for the gene known as Cytochrome P450 2D6 or CYP2D6.

The gene 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 of some 7 percent of patients. While tests exist that can detect variations in the gene, Gentris said its testing technology include DNA-based controls that make results more reliable.

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

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

The GentriSure products are part of Gentris’ strategy to develop pharmacogenomics products that help drug companies develop safer products and also help protect patients from adverse reactions to drugs based on their own genes.

CYP2D6 diagnostic testing has been available in the past, but materials came from what Gentris calls “surplus human specimens” as well as synthetic materials.

The Gentris tests were conducting utilizing a device from Roche called the AmpliChip. It is the only FDA approved device for use in CYP2D6 testing.