German SME with high expertise in epigenetic-marker based in vitro diagnostic (IVD) test development is looking for technology and commercialization partners for proprietary head-and-neck cancer diagnostics

Young German SME specialized in molecular biology and cancer diagnostics is currently developing a fast and reliable diagnostic test based on epigenetic changes (DNA methylation) which are characteristic for cancer cells. These highly informative biomarkers are currently validated in two clinical trials, applicable for early detection of tonsil and oropharynx carcinoma in screening as well as post-surgical care settings. Seeking medical partners for license and technical cooperation agreements.

Head-and-neck cancer including lips, oral cavity, larynx, oropharynx (tonsils, soft palate, base of the tongue), nasopharynx, hypopharynx culminates globally in 830.000 cases and 430.000 deaths per year.
Failure in precision detection of head and neck tumors (HNC) and unclear symptoms lead to a very long and unsuccessful search of courses for illness. Treatment pathways of HPV+ and HPV- tumors have to be differentiated and post-surgical care has to be improved.
Head and neck tumors are mostly detected late: more than 50% of the cases are diagnosed in an advanced stage -> high mortality (Globally 550.000 new carcinoma, more than 300.000 deaths p.a.). In addition to risk factors tobacco and alcohol, infections with HPV are leading to a strong increase in HPV-associated oropharynx tumors.
Therapeutic concepts have not undergone major changes within the last 20 years, but several innovative candidates are in advanced pharmaceutical development. More than 50% of patients are at risk of tumor relapse within two years after surgery.
Hallmarks of head-and-neck cancer cases:
• main causes: alcohol and tobacco abuse
• new main cause for oropharyngeal cancer: HPV infection, mainly HPV16
• most cancers are detected late → high mortality
• molecular markers may allow early detection

Current diagnostics for head-and-neck cancer comprises 
• diagnostic imaging
• endoscopy screening
• bioscopy screening
• dental diagnostics
• other diagnostics

Trends to molecular diagnostics are emerging due to options for companion Diagnostics and post-surgical surveillance, paving the way into the screening.

The young German biotech company has validated a highly precise set of epigenetic markers for detection of head-and-neck cancer in tissue and is currently setting up the corresponding assay for saliva-based detection.

The company is looking for exclusive diagnostic providers in the cancer area especially in the US and Europe with corresponding technical background and capabilities for market promotion. Seeking medical partners for license and technical cooperation agreements. Alternatively with interest in joint technology development partnerships.

Proprietary epigenetic markers, developed by the company in connection with a reknown university hospital since 2015, have various advantages:
• specifically linked to carcinogenesis of tumor cells and can be precisely detected in saliva as well
• detect stable and robust DNA cell regulation mechanisms 
• easy to use and objective read-out: Markers detected with established PCR-based technology
• fast turn-around: time to result < 6 h, hands-on time < 2h
• robust and economic - no specific requirements for the material used in the test

A new CE-IVD marked a diagnostic test for postsurgical care of head-and-neck cancer cases will be available by end of 2021, with the target to
• demonstrate good sensitivity for the relevant cancer cases (remaining cancer tissue which has not been cleared by therapeutic methods or recurring tissue)
• non-invasive diagnostic method for secondary and tertiary prevention

MDx tests for head-and-neck tumor diagnostics in post-surgical care under development, clinical study for selected screening cohorts will be launched in 2021

IP under development and under discussion with a reknown IP protection lawyer who was also involved in IP strategy of a proprietary epigenetic marker set for cervical cancer diagnostics (CE-IVD marked product)

Partners sought for license agreements and technical cooperation agreements: 

The company is looking for exclusive diagnostic providers in the cancer area especially in the US and Europe with corresponding technical background and capabilities for market promotion, alternatively or as well with an interest in joint technology development partnerships.
Looking for:
•	therapeutic companies with oncology products for head-and-neck cancer (also as CDx possible)
•	MDx platform providers
•	MDx marketing and distribution companies 
•	MDx development companies