mtm laboratories, a developer and manufacturer of In-Vitro diagnostic devices, has launched CINtec Plus, a cervical cancer screening product in Europe.
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.
The CINtec Plus Kit is an immunocytochemistry assay for the simultaneous qualitative detection of the p16INK4a (p16) and Ki-67 proteins in cervical cytology preparations. 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 clinical utility across a wide range of applications in cervical cancer screening and management.
CINtec Plus is the latest 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.
The laboratory said that the CINtec Plus improves the accuracy of cytology-based cervical cancer screening; is the first tool for efficient management of women with LSIL cytology; lowers the rate of false positive results in the management of women with ASC-US cytology, irrespective of age; defines an immediate management path for women who are HR-HPV positive and Pap Test negative and a positive test result with CINtec Plus is a clear indicator to refer women to colposcopy. In the US the product will be available as a Class 1 IVD without claims.
Robert Silverman, CEO of mtm laboratories, said: “The combination of both high sensitivity and specificity in a single test is what sets CINtec Plus apart from currently available diagnostic tests. 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.”