Epigenomics appointed DPC Lebanon as the commercialization partner for its colorectal cancer blood test Epi proColon, in Lebanon, the United Arab Emirates, Saudi Arabia, Qatar, Kuwait, Syria, Jordan, and Egypt. Agreements for distribution of the test in Turkey and Israel were signed earlier this month with Dateks and Pronto Diagnostics, respectively. “Signing this deal with DPC completes the picture for the Middle East,” comments Geert Nygaard, Epigenomics CEO.
Epi proColon identifies Epigenomics’ Septin9 colorectal cancer biomarker in blood plasma. The test was granted a CE mark in October 2009, and represents the first CE-marked molecular diagnostic for the early detection of colorectal cancer in blood samples, the firm claims. The test is marketed directly by Epigenomics in Germany, Austria, and Switzerland. Its strategy for other approved territories is to distribute the test through both direct commercialization efforts and a distributor network.
Epi proColon has not been approved as a clinical diagnostic in the U.S., but Epigenomics non-exclusive licensee, ARUP Laboratories, launched a laboratory-developed Septin9 colorectal cancer blood test in the U.S. during July. The test is aimed primarily as an aid to diagnosis in patients who cannot or will not undergo the established colonoscopy-based screening methods.
Also in July, Epigenomics made the European launch of its second CE-marked IVD, the Epi proLung BL Reflex Assay. The assay detects methylated DNA of the SHOX2 gene in bronchial lavage. Epigenomics claims the test can help pathologists and clinicians to establish the presence of malignancy with more certainty in patients with suspected lung cancer when conventional diagnostic procedures fail or deliver inconclusive results.
Epigenomics is separately working with early-access partners to finalize the clinical validation of a prostate cancer prognostic test based on the mPITX2 biomarker. The test is in development to help predict the risk of prostate cancer recurrence after prostatectomy.