Study results presented at USCAP, Washington, DC, March 20-26th

Heidelberg, Germany- March 23, 2010- mtm laboratories today announced the presentation of a study showing that dual staining for p16 and Ki-67 has the potential to provide high accuracy (high sensitivity and high specificity) for high-grade cervical disease. This study used a prototype of the CINtec® PLUS Cytology kit that was launched by mtm on March 8 in Europe and will be presented today at the 99th United States & Canadian Academy of Pathology (USCAP) annual meeting in Washington, DC.

The study, conducted by Magee Women’s Hospital of UPMC in Pittsburgh, focused on the interpretation of abnormal Pap cervical cytology results using a dual-stain for the p16 protein and the proliferation marker Ki-67. p16 over-expression in the cervix is a highly validated biomarker for the HPV-induced oncogenic transformation that marks the onset of cervical disease while Ki-67 is a marker for active cell proliferation. In total 661 prospectively collected abnormal cytology specimens with biopsy follow up data available were subjected to dual staining. In this way it was possible to assess whether the dual stain can accurately predict which of these abnormal specimens harbored high-grade cervical disease (CIN2+). At present existing screening technologies lack either the sensitivity or specificity to accomplish this so most abnormal cytology results have to be followed up with invasive and in often unnecessary procedures. The results indicate that the dual staining approach may have the potential to provide both high sensitivity to the underlying high-grade disease and also high specificity, as in this study it was able to accurately predict which women with abnormal cytology had real evidence of disease when confirmed by biopsy.

Bob Silverman, CEO of mtm laboratories said: “This study with a prototype demonstrates that CINtec® PLUS has the potential to establish a new benchmark for cervical cancer screening with our dual staining approach. The greater accuracy in identifying women most likely to harbor established disease, as demonstrated in the study could help to reduce the number of women with abnormal but benign cytology who have to face unnecessary procedures. As a result resources could be targeted specifically at those women who most need intensive follow-up.”

The title and authors of the presentation are as follows:

Dual-Stain for P16 and Ki-67 in the Interpretation of Abnormal PAP Cytology Results: A Prospective Study
M Chivukula, RM Austin, A Duwe, T Friedman, J Masko, N Mauser, R Ridder. Magee Women's Hospital of UPMC, Pittsburgh, PA; MTM Laboratories, Heidelberg, Germany

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About mtm laboratories AG
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

In the US the product is available as a Class 1 IVD without claims. The utility as described in this press release and as investigated in the cited study have not been cleared or approved by the United States Federal Food and Drug Administration.


Further Information:
Bob Silverman
CEO
mtm laboratories AG
t: +1 508-366-8334
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Dr. Douglas Pretsell
Associate Partner
College Hill
t : +49 (0)89 57 00 18 06
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