Looking for distribution partners in Europe, Asia and the US for highly reliable molecular in vitro diagnostic (IVD) test for screening, triage and follow-up care in cervical cancer diagnostics

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 a high-cost burden on all players in the health economy system. As a consequence, the medical need is twofold: the introduction of effective screening systems in less developed regions and reduction of over-therapy in more developed regions. 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 increase the risk of preterm birth and perinatal death. The German SME specialized in molecular biology and cancer diagnostics 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. 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. 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, preferring licensing agreement. The other group of potential partners may derive from pharmaceutical companies focused on women's health segments with cooperation under technical cooperation agreements. For the head-and-neck and ovarian cancer pipeline projects, the company is also interested in joint technology development partners.