A new biomarker combination for cervical cancer screening has been launched in the UK and across Europe.
CINtec PLUS from German company mtm laboratories combines sensitivity and specificity in the diagnosis and management of cervical cancer.
The new test will be launched directly in the UK, Germany, Italy, Spain and France, and will be available in other countries through mtm's distributors.
CINtec PLUS combines the diagnostic biomarker p16 with the proliferation marker Ki-67, thus providing both high sensitivity and high specificity.
The accuracy of this test in detecting pre-cancerous cervical lesions has been demonstrated in three clinical trials with 30,000 women across Europe. The trials showed that CINtec PLUS had significant clinical value across a wide range of applications in cervical cancer diagnosis and management.
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."
CINtec PLUS is the latest in a line of screening tests from mtm laboratories using the p16 biomarker. CINtec Histology and CINtec Cytology are already available in Europe.
Based in Heidelberg, Germany, mtm laboratories AG specialises in developing and manufacturing in vitro diagnostic devices for use in the early detection and diagnosis of cervical cancer.