Gentris Corporation Announces FDA 510(k) Submission For GentriSure™ Human Genomic DNA Reference Controls For CYP2D6 Gene

Gentris Corporation (Gentris), a leading global provider of applied clinical pharmacogenomic services and diagnostic product solutions, today announced that the company has completed an FDA 510(k) submission for six Human Genomic DNA Reference Controls for the Cytochrome P450 2D6 gene (CYP2D6). Under the GentriSure™ brand, the six products include: CYP2D6 *4A/*2AxN, CYP2D6 *29/*2AxN, CYP2D6 *2M/*17, CYP2D6 *3A/*4A, CYP2D6 *6B/*41 and CYP2D6 *1/*5 Human Genomic DNA Reference Controls. Roughly 20 percent of all commonly prescribed drugs are known to be metabolized by the liver enzyme, CYP2D6. Approximately seven percent of the U.S. population carries genetic variations of the CYP2D6 gene which could result in unexpected changes in the way patients react, including severe adverse reactions. Recently the FDA made a public announcement that it intends to relabel the breast cancer drug, tamoxifen, because efficacy can be affected in patients with inherited genetic variants that cause deficiencies in CYP2D6. Routine laboratory tests are currently available that can detect CYP2D6 variants to help predict patient outcome before drug treatment. However, without proper controls, the results of these tests cannot be validated and may be unreliable.

Gentris’ reference controls are the first commercially available source of well-characterized and consistent genomic material for CYP2D6 testing, obtained with informed consent, and produced under Good Manufacturing Practice (GMP) conditions. Until now, the only reference materials available to the rising number of laboratories performing CYP2D6 diagnostic testing were leftover human specimens, and there are limitations and ethical concerns in using this source of controls. Other control materials are available strictly for research purposes and not of the proper quality required in clinical diagnostic testing. The ideal solution to these dated alternatives, Gentris’ reference controls promote necessary standardization across clinical laboratories and facilitate sound proficiency testing.

“Clinical laboratories are now realizing that consistent, properly consented reference controls are just as important in diagnostic testing as the tests themselves,” commented Gentris CEO Michael Murphy. “Being the first to file a 510(k) submission for CYP2D6 reference controls is a tremendous milestone for Gentris and came as a direct result of our dedication to innovation and quality in the diagnostic product market. This submission represents the culmination of significant amounts of time, effort and work. We have no doubts that our investment will put us at the forefront of the $2 billion molecular diagnostics market, the fastest growing segment in the clinical laboratory business.”

In compliance with strict FDA submission requirements, Gentris conducted user trials at three outside, independent sites to validate the efficacy and quality of these products. The sites included one of the world's largest clinical reference laboratories, a world-renowned reference laboratory for national and international clinics and hospitals, and an independent laboratory spun out of a university that specializes in clinical pharmacogenetic testing. Notably, GentriSure™ Human Genomic DNA Reference Controls were tested on the Roche AmpliChip®, CYP450 Test, the only FDA cleared device for CYP2D6 testing on the market. Gentris has already identified distributors for GentriSure™ Human Genomic DNA Reference Controls in the U.S and Europe, and is currently seeking distribution partners in Japan.

The company anticipates this to be the first of many FDA 510(k) submissions including additional reference controls for other genes such as CYP2C19, CYP2C9 and VKORC1. Currently the GentriSure™ Human Genomic DNA Reference Controls are available for research use.

###