German biotech SME specialized in molecular biology and cancer diagnostics developed a fast and reliable diagnostic test based on epigenetic changes (DNA methylation) which are characteristic for cancer cells and applicable for early detection. Seeks medical partners for research and product development projects, related to epigenetic-marker based in-vitro diagnostics (IVD) testing in defined oncology indications with a high unmet medical need, for research and technical cooperation agreements.

A young German biotech SME with strong involvement in regional and national health clusters plans to widen its international scope. The company is specialized in molecular biology and cancer diagnostics and has developed a fast and reliable diagnostic test based on epigenetic changes (DNA methylation) which are characteristic for cancer cells. These highly informative biomarkers validated in clinical trials and applicable for early detection of cervical cancer. Corresponding marker sets for head-and-neck tumor and ovarian cancer are also validated.

The SME sized company is operating in ISO 13485 certified development and production labs. The team is developing epigenetic cancer tests since more than 10 years and is marketing an epigenetic triage test for clarification of unclear Pap or HPV screening results in the course of cervical cancer screening. The company is ready to develop a cost-effective Point-of-Care (POC) cervical cancer diagnostics test based on its proprietary cervical cancer diagnostic and prognostic biomarkers.
The company is developing diagnostic and prognostic kits in further indications based on epigenetic markers and is open for joint research & development projects to identify, validate and develop proprietary diagnostic tests in further oncology indications with a high unmet medical need.

The company is looking for strategic partners in product development of epigenetic-marker based diagnostic tests in to-be-defined oncology indications or may also join research consortia in joint national and international projects under research and technical cooperation agreements.
Seeking medical partners for research and product development projects, related to epigenetic-marker based in-vitro diagnostics (IVD) testing in defined oncology indications with a high unmet medical need, for research and technical cooperation agreements. Partners are welcome from industry and research.

Proprietary epigenetic markers, developed by the company in connection with a reknown university hospital since 2008, have various advantages:
-	They are specifically linked to carcinogenesis of tumor cells – contrary to the current screening tests, which are in the case of cervical cancer linked to HPV infection.
-	They detect stable and robust DNA cell regulation mechanisms. 
-	Easy to use & objective read-out: Markers detected with established PCR-based technology.
-	Fast turn-around: Time to result < 6 h, hands-on time < 2h
-	Robust & economic: No specific requirements for the material used in the test
-	Diagnostic assays from the company show very high sensitivity and specificity both in screening as well as in triage testing settings.  

Expansion with lower-end market price products to emerging countries offers additional upsides. The company is working on proof-of-concept studies for the implementation of relevant biomarkers into point-of-care diagnostic tests, besides diagnostic tests for established real-time PCR platforms of large providers such as Roche Dx (Cobas Z480) and Life Technologies (Abi7500).

Besides the CE-IVD marked MDx test for cervical cancer and the MDx tests for head-and-neck tumors in development, the company is looking for strategic partners in joint product development or may also join research consortia in joint national and international project applications.

Patents already granted for EU, Canada, US and Japan; further territories via second patent family, currently in the PCT-phase (priority Sep 2017). Decade-long experience and first-mover advantage for the development of robust, reliable and CE-IVD marked diagnostic tests based on epigenetic markers (incl. bisulfite conversion and real-time PCR).

Seeking medical partners for research and product development projects, related to epigenetic-marker based in-vitro diagnostics (IVD) testing in defined oncology indications with a high unmet medical need, for research and technical cooperation agreements. Partners are welcome from industry and research.