A Powerful new biomarker combination for cervical cancer screening

Heidelberg, Germany; March 2, 2010 - mtm laboratories, a privately held diagnostics company today 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.

mtm laboratories AG is an ISO 9001 and ISO 13485 certified developer and manufacturer of In-Vitro Diagnostic Devices (IVDD) for use in the early detection and diagnosis of cervical cancer. The Company operates on a global basis with headquarters in Heidelberg, Germany and subsidiaries in the United States, France, Italy and Spain. Further information can be found at: www.mtmlabs.com


Further Information:
Bob Silverman
CEO
mtm laboratories AG
t: +1 508-366-8334
e: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Dr. Douglas Pretsell
Associate Partner, General Manager Munich
College Hill
t : +49 (0)89 57 00 18 06
e: This e-mail address is being protected from spambots. You need JavaScript enabled to view it


Notes for Editors

CINtec® PLUS
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. p16 over-expression in the cervix is a highly validated biomarker for the HPV-induced oncogenesis that marks the onset of cervical disease while Ki-67 is a marker for active cell proliferation.

Together they provide a unique combination of high sensitivity with high specificity in the identification of existing cervical disease setting CINtec® PLUS apart from current screening technologies.

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. The claims described in this press release have not been cleared or approved by the United States Federal Food and Drug Administration.