Results Published in the American Journal of Clinical Pathology

Heidelberg, Germany; March 1, 2010- mtm laboratories, a privately held diagnostics company, today announced the publication of new research showing that CINtec Histology p16 immunostaining significantly increased the accuracy for the diagnosis of high grade cervical lesions. This research is published in the March issue (Volume 133, pp 395-406) of the American Journal of Clinical Pathology (AJCP).

The article by Bergeron and co-authors under the title “Conjunctive p16INK4a Testing Significantly Increases Accuracy in Diagnosing High-Grade Cervical Intraepithelial Neoplasia” shows that CINtec Histology p16 immuno-stained specimens when used in combination with conventional H&E stained cervical specimens, significantly increases the accuracy in diagnosing high grade cervical lesions.

In the study, a Pan-European Trial in Histology, community based pathologists made independent diagnoses on a set of 500 H&E-stained cervical biopsy specimens. Results were compared to a Gold standard established by three gynecological pathology experts as consensus diagnoses. When p16 immunostained slides were added and conjunctively interpreted with the H&E stained slides, a significant increase in diagnostic accuracy for the detection of High Grade Cervical Intraepithelial Neoplasia was observed. Further, there was a significant improvement in inter-observer agreement in the diagnosis of high grade disease.

“CINtec p16 immuno staining delivers  a highly reliable and specific stain. The results of this study confirm that the conjunctive interpretation of p16 stained slides could significantly improve the routine interpretation of cervical histopathology” said Dr. Christine Bergeron, Director of the Pathology Department at Laboratoire Cerba in France and lead investigator for this study. “In clinical settings p16 is proving to be invaluable for pathologists for distinguishing between disease and non-disease. Immunostaining of p16 may help to avoid the false positive cases that result in unnecessary treatment. At the same time, screening for p16 will also help avoid false negative cases that may prevent women from receiving treatments  to ensure positive outcomes.”

Rüdiger Ridder, the CSO of mtm laboratories, added:
"A significant issue exists with the accuracy for making the final diagnosis for cervical disease.  Cervical cancer is a preventable disease as long as there is early therapeutic intervention. Tools that increase the accuracy of diagnosis will allow for both reducing missed disease, and avoiding the unnecessary treatment of women. CINtec Histology p16 immuno- staining increases the accuracy and reliability of the diagnosis of high grade pre-cancerous disease.”

For more details use this link to the abstract of the article in AJCP: http://ajcp.ascpjournals.org/cgi/content/abstract/133/3/395

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
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Dr. Douglas Pretsell
Associate Partner, General Manager Munich
College Hill
t : +49 (0)89 57 00 18 06
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Corresponding author of the study:
Dr. Ruediger Ridder
mtm laboratories AG
t: +49 (0)6221 64966 0
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Notes for Editors

The CINtec® family of diagnostic products
The basis of mtm’s IVD products, the proprietary p16INK4a biomarker, is strongly over-expressed in pre-cancerous and cancerous cells of the cervix. The over-expression of this biomarker is directly correlated to the oncogenic activity of High Risk Human Papilloma Virus (HR-HPV) that marks the generation of cervical cancer. These biomarker-based diagnostic assays hold the promise to bring high levels of sensitivity and specificity towards the detection of high grade cervical disease in adjunctive uses with conventional technologies. mtm's family of products is based on mtm's proprietary E6H4TM antibody clone which was specifically developed for immunochemistry applications in cervical histology and cytology specimens.

The CINtec® immunoassays are validated to provide a sensitive and specific method for the detection of p16INK4a in cervical tissues. The currently marketed CINtec® In-vitro Diagnostics (IVDs) have been developed for application on:
•    cervical biopsies (CINtec® Histology) and
•    cervical cytology preparations such as smears and liquid based cytology samples (CINtec® Cytology)
CINtec® products are available on a global basis through mtm's direct operations and distributors.
* In the US the product is available as a Class 1 IVD without claims. The claims described in this press release or in this publication have not been cleared or approved by the United States Federal Food and Drug Administration.