Test for better prevention of cervical cancer receives FDA approval

Women infected with high-risk types of human papillomavirus (HPV) have a high risk of developing cervical cancer. A test can help doctors to better assess this risk and identify those women who should be referred immediately for further diagnostic investigation. The test has now been approved by the US Food and Drug Administration (FDA) and will soon be widely available to doctors and patients. The test was developed by mtm Laboratories AG, a spin-off from the German Cancer Research Center and the University Hospital in Heidelberg, which was acquired by Roche in 2011.


Tissue section from the cervix: The brown color is an indication of malignant cells. © mtm laboratories

In 1999, scientists led by Magnus von Knebel Doeberitz from the German Cancer Research Center (DKFZ) and the University Hospital of Heidelberg founded mtm laboratories ("molecular tools in medicine") with the aim of developing the detection of the cancer protein p16 as a diagnostic test for the early detection of cervical cancer. The company was one of the first spin-offs in which the DKFZ held shares. The company developed the test and launched it under the name CINtec PLUS. The immunohistological method detects the simultaneous presence of the two biomarkers p16 and Ki-67 in a single cell. A positive result indicates that an HPV-infected woman has already developed a precancerous stage that requires immediate clinical clarification. HPV-positive women, on the other hand, in whom the test is negative, have not developed a precancerous stage, so further screening intervals can be significantly extended. In 2011, mtm laboratories was acquired by Roche, a leading international provider of diagnostics and therapeutics. Roche has now received US FDA (Food and Drug Administration) approval for CINtec PLUS to help clinicians improve cervical cancer prevention. FDA approvals are based on very extensive studies involving many thousands of participants. To date, there are only a few examples of products from German biotech companies that have made it this far. It is expected that the test will be commercially available on a broad basis in the USA in the course of 2020. CINtec PLUS cytology provides crucial information on which HPV-positive women can benefit most from an immediate referral to colposcopy. This is an important step to individualize patient care and prevent both over- and under-treatment. Rainer Wessel, Chief Innovation Officer at the DKFZ, calls the development from the idea to a marketable test kit an "exemplary success story". "Thanks to the initiative of the company founders led by Magnus von Knebel Doeberitz, an important cancer test will soon be available worldwide because FDA approvals usually have a signal character for the approval authorities of other countries. This example shows that spin-offs are an excellent opportunity to further develop promising inventions from basic research into medical products. The DKFZ supports inventors in all phases of this process."


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