- CEO
- Gregory K. Hamilton
- Full Time Employees
- 33
- Sector
- Healthcare
- Industry
- Medical - Diagnostics & Research
- Address
- Geneststrasse 5 Berlin Germany 10829
- IPO Date
- Jul 10, 2013
- Business
- Epigenomics AG is a Germany-based molecular diagnostics company specializing in the development and commercialization of blood-based diagnostic products for the early detection, prognosis, and monitoring of cancers. The company's core products include Epi proColon, a blood test that measures the methylation status of the SEPT9 gene promoter to aid in colorectal cancer screening; Epi proLung, which assesses the methylation status of the SHOX2 gene for lung cancer diagnosis; and additional molecular diagnostic assays based on DNA methylation biomarkers. Epigenomics also offers comprehensive services encompassing biomarker discovery and validation, assay development for DNA methylation and RNA expression analysis, regulatory approval support, and manufacturing of in vitro diagnostic (IVD) products compliant with ISO 13485 and FDA regulations. These offerings serve healthcare providers and research institutions across Europe, North America, and Asia.
Founded in 1998 and headquartered in Berlin, Germany, Epigenomics operates a wholly-owned subsidiary, Epigenomics Inc., in Seattle, Washington. The company targets multiple cancer indications with high unmet medical needs, focusing on blood-based testing solutions that provide non-invasive, early cancer detection. Epigenomics' proprietary technology platform leverages epigenetic biomarkers to develop IVD tests that address critical diagnostic gaps in oncology.
In 2023, Epigenomics completed a strategic transaction involving the sale of substantially all of its molecular diagnostic assets, including patents and biobank, to New Day Diagnostics LLC, a U.S.-based full-service diagnostics and contract research organization. This deal, valued at up to $12.05 million plus royalties extending through 2043, was designed to facilitate the further development, commercialization, and potential reimbursement of Epigenomics’ "Next-Gen" blood-based colorectal cancer test, known as Epi proColon Next-Gen. The sale enables Epigenomics to secure future cash flows while transferring resource-intensive development responsibilities to New Day Diagnostics, which combines biomarker expertise for enhanced colorectal cancer detection. This strategic shift reflects Epigenomics' focus on maximizing shareholder value through partnership and operational restructuring while maintaining involvement in the diagnostic space through royalty streams and collaborations.
Overall, Epigenomics AG is positioned within the molecular diagnostics industry, concentrating on the cancer diagnostics segment, with its product portfolio anchored in epigenetic biomarker technology for blood-based cancer detection. Its operations span Europe and the United States, serving clinical and research markets with advanced diagnostic tests and affiliated services.
This description captures Epigenomics AG’s key products, services, geographic footprint, recent strategic asset sale, and corporate background in a style consistent with financial data providers.