mtm laboratories, a privately held diagnostics company from Heidelberg, Germany, announced the launch of CINtec® PLUS, the company’s next generation cervical cancer screening product with unmatched accuracy for the screening and management for cervical cancer. CINtec® PLUS will be launched with claims direct in Germany, Italy, Spain, France and the UK, and will also be available in other parts of the world via mtm’s nominated distributors.
CINtec® PLUS combines the p16 biomarker, widely validated for diagnostic purposes, with the proliferation marker Ki-67. By combining these two markers in a single diagnostic test, CINtec® PLUS provides both high sensitivity and high specificity for detecting high-grade cervical disease. The performance of this test for highly accurate detection of pre-cancerous cervical lesions has been demonstrated in three clinical trials conducted in over 30,000 women across Europe. In these studies, CINtec® PLUS was demonstrated to have significant clinical utility across a wide range of applications in cervical cancer screening and management. “The combination of both high sensitivity and specificity in a single test is what sets CINtec® PLUS apart from currently available diagnostic tests” said Robert Silverman, CEO of mtm laboratories, “What this means for patients and clinicians is that early stage disease can be identified accurately in time for effective medical intervention. In comparison to the currently available technologies, CINtec® PLUS will minimize over or under diagnosis.” CINtec® PLUS is the newest in a line of diagnostic and screening tests using the p16 biomarker that have been developed by mtm laboratories. CINtec® Histology and CINtec® Cytology are already marketed in Europe and were launched in 2007.