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TODE20180813001

Highly reliable molecular in vitro diagnostic (IVD) tests for screening, follow-up care and therapeutic decisions in cancer diagnostics, based on proprietary epigenetic biomarkers

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ABSTRACT

A young German SME specialized in molecular biology and cancer diagnostics has developed a fast molecular diagnostic MDx 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. Seeking medical partners for licensing and technical cooperation agreements.

 

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FULL DESCRIPTION

Cervical cancer is the third most common cancer in women world-wide, with approx. 530,000 new cases and 275,000 deaths per year. In contrast to other cancers it mainly affects young women with a maximum of incidence below 30 years of age.
Current screening programs have reduced mortality over the past 40 years. However, they require further improvements because up to 50% of all precancerous lesions or cancers are overlooked, while too many surgeries are performed. Unnecessary surgeries increase the risk for preterm birth (factor 2-4) and perinatal death risk by a factor of 10 in post-surgery pregnancies and put high cost burden on all players in the health economy system.
As a consequence, the medical need is twofold: introduction of effective screening systems in less developed regions and reduction of over-therapy in more developed regions.
In the area of head-and-neck and ovarian cancer, the company’s marker panels may support post-surgical treatment decisions and may thus also be implemented as companion diagnostics for chemotherapy treatment decisions. This is especially important as in up to 65% of all cases, these types of tumours frequently relapse (recidivation) following surgical removal because the patient is resistant to platin-containing chemotherapy substrates.

Reliable triage testing of positive screening patients is important to reduce their psychological burden in ongoing watchful-waiting and retesting periods. Triage testing of positive screening results by the company’s MDx test therefore decreases psychologic stress evoked by false-positive diagnoses. This is especially important for women still in family planning, because invasive diagnostics and esp. surgery increases the risk for preterm birth and perinatal death.

The company has already licensed out the test for the Chinese market to a major medical player in China, including all relevant tech transfer documents. Following this market entry in China, the company is open to discuss commercialization of the test in all other regions, especially Europe and the US. Potential partners may derive from diagnostics companies which are already active in the HPV-testing segment, and/or which are seeking expansion for their own MDx platforms. Pharmaceutical companies focused on women's health segments are also potential partners, preferring licensing 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.
• HPV-testing providers
• Liquid-Based-Cytology (LBC) companies
• MDx Platform Providers
• MDx Marketing and Distribution Companies and MDx Development Companies
For the head-and-neck and ovarian cancer pipeline projects, the company is interested in joint technology development partners.


Partner expertise sought:

- Specific area of activity of the partner: Medical partners sought for License 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.
• HPV-testing providers
• Liquid-Based-Cytology (LBC) companies
• MDx Platform Providers
• MDx Marketing and Distribution Companies
• MDx Development Companies

For the head-and-neck and ovarian cancer pipeline projects, the company is interested in joint technology development partners.


Advantages & 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

Established screening programs in cervical cancer based on liquid-based cytology (LBC) samples have prepared the market for innovative triage tests. Such LBC samples allow different tests from one cervical smear sample: cytology, HPV, and other biomarkers.

The CE-IVD cervical cancer test of the company is the ideal triage test in this setting because it
• detects all cancer cases
• has good sensitivity for the relevant precancerous stage CIN3 (i.e. detects the relevant CIN3 which
may progress to cancer) - prognostic value as USP
• has excellent specificity with normal cytology

The corresponding market potential is more than €1 billion per year. It offers and includes a significant upside from advances in implementation of HPV testing in primary cervical cancer screening.
Expansion with a lower-end market price product to emerging countries offers additional upsides. The company is working on proof-of-concept studies for implementation of relevant biomarkers into point-of-care diagnostic tests.


Development Stage:

Already on the market - MDx test for cervical cancer CE-IVD marked; MDx tests for head-and-neck tumor and ovarian cancer in development


IPR:

Secret Know-how,Patents granted,Trade Marks - Patents already granted for EU, Canada, US and Japan; further territories via second patent family, currently in the PCT-phase (priority Sep 2017)

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KEY INFORMATION

Country of origin
GERMANY
Date created
20/08/2018
Date updated
21/02/2020
Deadline
24/08/2020

PARTNERSHIP(S) SOUGHT

License agreement Technical cooperation agreement

CLASSIFICATIONS

INDUSTRY SECTORS
Medicine and Health \ Life Sciences \ Big drug delivery client
TECHNOLOGY KEYWORDS
BIOLOGICAL SCIENCES / Medicine, Human Health / Clinical Research, Trials / BIOLOGICAL SCIENCES / Medicine, Human Health / Cytology, Cancerology, Oncology / BIOLOGICAL SCIENCES / Medicine, Human Health / Diagnostics, Diagnosis / BIOLOGICAL SCIENCES / Medicine, Human Health / Medical Technology / Biomedical Engineering / BIOLOGICAL SCIENCES / Biology / Biotechnology / Cellular and Molecular Biology
COMMERCIAL KEYWORDS
Manufacture of medical and dental instruments and supplies
MARKET KEYWORDS
GENETIC ENGINEERING/MOLECULAR BIOLOGY / Cellular and Molecular Biology / MEDICAL/HEALTH RELATED / Diagnostic / Diagnostic services / MEDICAL/HEALTH RELATED / Diagnostic / In-vitro diagnostics / MEDICAL/HEALTH RELATED / Clinical Medicine / Gynaecology / MEDICAL/HEALTH RELATED / Clinical Medicine / Oncology
A2020