Epigenomics last week said it obtained a non-exclusive license from Affymetrix to access its microarray technology to develop array-based in vitro diagnostics for oncology.
The Berlin-based company can now transfer its diagnostic and prognostic tests for prostate and breast cancer — its first products for the molecular diagnostic market — onto Affy's platform to use in clinical trials so the US Food and Drug Administration can begin reviewing them sometime next year.
By partnering with Affy, Epigenomics has become the latest molecular diagnostics firm to run its tests on Affymetrix's GeneChip Scanner 3000Dx, joining Roche, bioMerieux, Veridex, Almac Diagnostics, and PathWork Informatics in the queue to get GeneChip-based diagnostics cleared by the FDA.
Yvonne Hartwig, Epigenomics' spokesperson, said this week that the company's first product on the Affy platform will be its Prostate Cancer Molecular Classification Test, a prognostic for post-prostatectomy prostate cancer recurrence.
This test will "provide significant independent information, which will help physicians and patients understand the potential for post-prostatectomy cancer recurrence and treatment management," Hartwig told BioArray News in an e-mail. Epigenomics' tests are developed using its in-house DNA methylation analysis tools.
The company's objective is to file for an investigational device exemption, an FDA regulatory status that will permit Epigenomics to use the test in clinical trial studies that are scheduled to begin next year, Hartwig said.
According to Hartwig, Epigenomics has also initiated a discussion with the FDA concerning its prostate cancer test, and the company expects to submit the test for clearance in the second half of 2007. CE marking is expected in 2008, she added.
Epigenomics' window for entering the market coincides with the scheduled launches of a number of diagnostics that run on the Affy platform. In March, former Roche Molecular CEO Heiner Dreismann told BioArray News that the firm — which debuted the AmpliChip on the Affy platform in 2004 — would have a chip for leukemia prognosis available for the research market in 2007 and could get FDA clearance in 2009 (see BAN 3/7/2006).
Other Affy-powered diagnostics scheduled to hit the market by the end of this decade include tests for breast and prostate cancer being developed by Veridex, and Almac Diagnostics, which has not publicly discussed its diagnostic plans since joining the Powered By Affymetrix program in October 2005 (see BAN 10/25/2006).
Qiagen OEM Deal
Along with its access to Affy's platform, Epigenomics hopes an earlier agreement with Qiagen will help it enter the molecular diagnostics marketplace.
Qiagen and Epigenomics' agreed last year to co-develop reagent kits that use Epigenomics' bisulfate technology and to provide it with kit components for molecular diagnostic products. Qiagen launched its EpiTect Biosulfite Kit for sample processing for DNA methylation analysis in May.
According to to Hartwig, Qiagen is now developing a kit, based on Epigenomics technology, "for use in conjunction with a range of bioarrays to be manufactured for Epigenomics by Affymetrix."
"The three technologies will form a ... workflow for clinical application of Epigenomics pipeline of DNA methylation-based molecular diagnostic products," she said.
Qiagen has similar OEM deals with Osmetech and Affymetrix. Andreas Schäfer, the director R&D at Qiagen, told BioArray News last month that the company is actively pursuing more OEM deals with array companies (see BAN 6/13/2006).