Epigenomics AG (Berlin, Germany), a cancer molecular diagnostics company, signed a nonexclusive licensing agreement for its DNA methylation biomarker Septin9 with Companion Dx Reference Lab (Houston, TX, USA).

Under the terms of the agreement, Companion Dx has obtained rights to establish and commercialize a blood-based, laboratory-developed test (LDT) using methylated Septin9 as biomarker for the detection of colorectal cancer. Epigenomics is entitled to double digit royalties on sales.

The v2 region of the Sept9 promoter is methylated in colorectal cancer tissue compared with normal colonic mucosa. Using highly sensitive real time polymerase chain reaction (PCR) assays, methylated Sept9 was detected in the blood of colorectal cancer patients. This alternate methylation pattern in cancer samples is suggestive of an aberrant activation or repression of the gene compared to normal tissue samples.

The agreement with Companion Dx complements Epigenomics’ LDT agreements with Quest Diagnostics, (Madison, NJ, USA), Arup Laboratories (Salt Lake City, UT, USA), and Warnex Medical Laboratories (Laval, QC, Canada) in North America. In addition, Abbott Molecular (Des Plaines, IL, USA) has a worldwide, nonexclusive license to develop and to commercialize IVD test kit products while Qiagen (Hilden, Germany) and Sysmex (Kobe, Japan) have acquired options to do so.

Epigenomics is a molecular diagnostics company developing and commercializing a pipeline of products for the screening and diagnosis of cancer. The company's lead product, Epi proColon, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the USA.

Companion Dx Reference Lab specializes in pharmacogenomics testing and cancer companion diagnostics. Personalized pharmacogenomic evaluations reveal the patient's risks for serious side effects and reduced drug effectiveness, allowing the physician to make clinical decisions that improve therapeutic outcomes prior to therapy.

Related Links:
Epigenomics AG
Companion Dx Reference Lab