Gentris Corporation (Gentris) today announced FDA clearance for GentriSure™, its first product line and the first FDA-cleared product for this specialty pharmacogenomics company. These six Human Genomic Reference Controls, the first products of their kind approved by a federal agency, are used to perform diagnostic testing for the Cytochrome P450 2D6 gene (CYP2D6). Gentris, a leading global provider of applied clinical pharmacogenomic services and diagnostic product solutions, can now add FDA approval and a GMP-compliant device manufacturer to its long list of accomplishments.
“The FDA’s approval of our GentriSure product line is an extremely important achievement for Gentris,” said Michael Murphy, the company’s President and CEO. “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.”
FDA approval reflects the growing demand for consistent, reliable genomic material obtained from properly consented patients. Previously, the only other sources of available reference materials for CYP2D6 diagnostic testing were surplus human specimens and synthetics. All of these materials are generally less desirable due to consistency, ethical and representative issues.
“Gentris’ FDA-cleared human genomic reference controls for CYP2D6 set an important precedent in the pharmacogenomics arena,” commented William Evans, Pharm.D., Director and CEO, St. Jude Children’s Research Hospital in Memphis, Tennessee. “Controls are as important as tests in ensuring accurate and safe clinical testing. As one of the few FDA cleared pharmacogenomic-related diagnostics, each new Gentris product is a step closer to personalized drug treatment,” said Dr. Evans.
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. GentriSure controls were tested on several CYP2D6 test platforms including laboratory developed assays. Notably, GentriSure Human Genomic Reference Controls were tested on the Roche AmpliChip®, CYP450 Test, the only FDA cleared device for CYP2D6 testing on the market.
About Gentris Corporation
Gentris Corporation (gentris.com) is a leading global provider of applied clinical pharmacogenomic services and diagnostic product solutions. As pioneers in the field of pharmacogenomics, Gentris helps pharmaceutical companies and clinical research organizations effectively integrate pharmacogenomics into their drug development programs to deliver safer, more effective compounds to the market sooner. Gentris is developing validated reference controls and diagnostic test kits that will bring the promise of personalized medicine to physicians and patients, which will enhance patient management, improve patients' response to therapy and revolutionize medicine through pharmacogenomics.