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mtm’s CINtec Cytology Kit has higher specificity than HR-HPV testing


mtm’s CINtec Cytology Kit has higher specificity than HR-HPV testing improving the detection of cervical disease

Series of Studies presented at EUROGIN in Nice, Nov 12-15 alongside other papers relating to mtm’s p16 biomarker based tests

Heidelberg, Germany; November 17, 2008. mtm laboratories today announced that a study presented last week at the 8th International Congress of EUROGIN (Nice, November 12-15) showed that mtm’s CINtec® Cytology Kit demonstrates comparable sensitivity but significantly higher specificity for the identification of high-grade cervical cancer than HPV (Human Papilloma Virus) testing in the triage of women with ASC-US and LSIL cytology results. The paper was presented by Dr. Karin Denton from the Department of Cellular Pathology, Southmead Hospital (Bristol, UK). The results from this study provided the clinical data basis for the launch of mtm’s CINtec® Cytology Kit in Europe with extended claims .

The CINtec® Cytology Kit uses the cyclin-dependent kinase inhibitor p16INK4a (p16) as a biomarker. Over-expression of p16 has been directly correlated to the oncogenic activity of high-risk HPV types that marks the generation of cervical cancer.

Two other notable studies presented at the conference focused on p16 as a biomarker used in conjunction with the proliferation marker Ki-67 in cervical cancer screening and diagnosis. Professor Dr. Karl Ulrich Petry of the Klinikum der Stadt Wolfsburg, Germany, showed data demonstrating that the simultaneous detection of the p16 and Ki-67 biomarkers in cervical cell preparations could provide a potential tool widely independent from morphology interpretation and with both a very high specificity and sensitivity for detecting cervical dysplasia. Dr. Mark H. Stoler, Department of Pathology, University of Virginia Health System (Charlottesville, USA) presented preliminary data examining the relative sensitivity and specificity of these two markers compared to HPV L1testing in diagnosing cervical biopsies. The study found that p16 and Ki-67 are both promising markers in differentiating high-grade pre-malignant cervical disease, vs. low-grade disease or normal tissue.

Finally, one other notable study looked at mtm’s Cervatec™ p16 ELISA test, which is currently only available in Germany. Professor Dr. Peter Hillemanns of the Department of Gynaecology and Obstetrics (Medizinische Hochschule Hannover, Germany) presented results of a large clinical trial demonstrating that by adding Cervatec testing to conventional Pap cytology the sensitivity of the Pap test (43%) could be more than doubled to higher than 86%, in the diagnosis of high grade cervical disease.

'These scientific presentations presented at the conference highlight the utility of p16 as a key biomarker for the identification of cervical disease,” said Bob Silverman, Chief Executive Officer for mtm laboratories. “Equivocal or mild results are clinically relevant since a portion of these actually harbour high grade disease, the immediate pre-cursor to Cervical Cancer, and as such cannot be ignored. This is why we launched CINtec® Cytology Kits in Europe with extended claims. The additional results relating to p16 used in conjuction with Ki-67, and the study looking at Cervatec™, confirm the value of testing options for cervical cancer that are both highly sensitive and highly specific.”

These studies were all presented at the 8th International Congress of EUROGIN in Nice, held on November 12-15. The congress 'Joining Forces for Cervical Cancer Prevention' is organized by the European Research Organization on Genital Infection and Neoplasia (EUROGIN). The titles and contributors to each paper mentioned above are as follows:

“Clinical utility of p16 immunocytochemistry for the triage of ASC-US and LSIL Pap cytology results.” Denton KJ, Bergeron C, Klement P, Trunk MJ, Ridder R

“The problem with cervical biopsy diagnosis: can we fix it?” Stoler M, Atkins K, Galgano M, Brix W, Nassau S and Castle P

“Co-localized expression of p16 and proliferation marker Ki-67 within the same cervical cell as an independent indicator of cervical dysplasia” Petry KU, Duwe A, Klement P, Trunk MJ, Schmidt D, Ridder R

“Conjunctive use of the Cervatec p16 ELISA with pap cytology doubles sensitivity rate for detection of CIN2+ lesions in women aged 35 and younger” Hillemanns P, Klement P, Ridder , Petry KU (for the Cervatec Study Group)

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 is headquartered in Heidelberg, Germany but operates on a global basis and has 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
Phone: +49 (0) 6453 64818-0
E-Mail: contact[a]mtmlabs.com

Dr. Douglas Pretsell
Account Director, Munich Bureau Chief
College Hill
Phone: +49 (0)89 57 00 18 06
E-Mail: douglas.pretsell[a]collegehill.com

Notes for editors:

The CINtec® family of diagnostic products
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 target for mtm's cervical cancer early detection technology platforms is the evaluation of the over-expression of the cyclin-dependent kinase inhibitor p16INK4a. 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.

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.


Publisher Contact Information:

mtm laboratories AG
+49 (0) 6453 64818-0
contact@mtmlabs.com

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