Gentris Corporation announced today that it has completed an FDA 510(k) submission and is planning to market six Human Genomic DNA Reference Controls for the Cytochrome P450 2D6 gene (CYP2D6).
About 20 percent of commonly prescribed drugs are metabolized by the liver enzyme CYP2D6 while roughly 7 percent of the U.S. population carries genetic variations of the CYP2D6 gene that could cause unexpected reactions.
Recently the FDA announced that it will relabel tamoxifen, a breast cancer drug that does not work as well in patients with inherited genetic variants that cause deficiencies in CYP2D6.
There are lab tests that can detect CYP2D6 variants to help predict patient outcome before drug treatment, but without proper controls, the results of these tests may be unreliable.
“Clinical laboratories are now realizing that consistent, properly consented reference controls are just as important in diagnostic testing as the tests themselves,” said Gentris CEO Michael Murphy. “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.”
Gentris has teamed with distributors for GentriSure£ Human Genomic DNA Reference Controls in the U.S and Europe, and is currently seeking distribution partners in Japan. The company expects this will be the first of many FDA 510(k) submissions including additional reference controls for other genes such as CYP2C19, CYP2C9 and VKORC1. The GentriSure£ Human Genomic DNA Reference Controls are already available for research use.