Epigenomics AG has announced that it has transferred its prostate cancer molecular classification test, based on the PITX2 biomarker, to the Affymetrix GeneChip™ platform.
According to Epigenomics, this step towards completing product development and initiating pivotal studies was accomplished six months after concluding a strategic partnership with Affymetrix Inc.
This partnership provides Epigenomics with access to Affymetrix’s industry in vitro diagnostic microarray platform for commercialization of Epigenomics’ tissue based product portfolio.
The concordance study demonstrated that the prototype real-time PCR assays used in the research phase could be transferred to the Affymetrix platform. A 97.8% agreement between the methods was observed.
“Our depth of prior experience with DNA methylation microarrays made it possible to achieve this important step in product development on such a short timeline. We are now looking forward to moving this product into clinical validation.” said Dr. Michael Wandell, Senior VP Clinical, Regulatory & Quality, and Head of Epigenomics Product Development.
"We expect that this assay will provide physicians and patients with valuable new information for more accurate prediction of prostate cancer relapse, based on the tumor’s molecular signature."
The completion of the concordance study now paves the way for pivotal clinical studies to commence, as scheduled, in 2007.
"We are pleased with the progression of events which allows us to continue to meet our product and clinical development timelines," added Dr. Wandell.
Epigenomics will fulfill regulatory requirements through submission of a “de novo 510(k)” for this test based on an Early Collaboration Meeting with the FDA in August this year. FDA makes this regulatory pathway available to allow market introduction of lower risk medical devices.
In addition, Epigenomics will file an Investigational Device Exemption (IDE) in Q1 2007 to support this application.