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Partners for research project and product development sought for detection, validation and commercialization of epigenetic-marker based in-vitro diagnostics (IVD) testing in oncology indications with high unmet medical need

Summary

Profile Type
  • Technology offer
POD Reference
TODE20241129003
Term of Validity
29 November 2024 - 29 November 2025
Company's Country
  • Germany
Type of partnership
  • Commercial agreement with technical assistance
Targeted Countries
  • All countries
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General information

Short Summary
Partners for research project and product development sought for detection, validation and commercialization of epigenetic-marker based in-vitro diagnostics (IVD) testing in oncology indications with high unmet medical need
Full Description
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.
Advantages and Innovations
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).
Stage of Development
  • Already on the market
Sustainable Development Goals
  • Goal 3: Good Health and Well-being

Partner Sought

Expected Role of a Partner
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.
Type and Size of Partner
  • SME <=10
  • Big company
  • SME 11-49
  • University
  • R&D Institution
  • SME 50 - 249
Type of partnership
  • Commercial agreement with technical assistance

Dissemination

Technology keywords
  • 06001003 - Cytology, Cancerology, Oncology
  • 06001005 - Diagnostics, Diagnosis
  • 06002007 - In vitro Testing, Trials
  • 06002002 - Cellular and Molecular Biology
Market keywords
  • 05001001 - Diagnostic services
  • 05001002 - In-vitro diagnostics
  • 05001005 - Molecular diagnosis
  • 05004005 - Diagnostic equipment
  • 05005006 - Gynaecology
Sector Groups Involved
  • Health
Targeted countries
  • All countries