mtm Laboratories Launches Cervatec(TM) Assay For Cervical Cancer Screening

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Cancer / Oncology
Article Date: 06 Feb 2008 - 1:00 PDT

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mtm laboratories announced the launch of the CE-labelled Cervatec(TM) Assay and, at the same time, the results from a large prospective study demonstrating substantially superior sensitivity to the presence of disease over Pap test alone. The Cervatec™ ELISA assay will initially be commercialized in Central Europe as an adjunct to the Pap Test in screening of women aged 35 and younger.

mtm's Cervatec™ Assay is based on the quantitative detection of p16, a novel biomarker for a cellular protein which is up-regulated in the presence of cervical disease. As such p16 is a highly sensitive marker for the presence of cervical disease. The product is to be used in conjunction with the conventional Pap Test for the detection of cervical cancer and its precursor lesions. A cervical sample is taken by the clinician and then sent to a clinical laboratory for processing. The presence of the biomarker p16 in lysed cervical specimens is quantitatively measured by a colorimetric sandwich ELISA which can be run manually or on automated ELISA platforms. Increased levels of the p16 biomarker indicate the presence of pre-cancerous and cancerous lesions of the cervix uteri in first-line screening.
In a prospective study involving more than 7.500 enrolled women aged 35 and below, results using Cervatec™ and Pap test were compared with biopsy-confirmed diagnoses. Cervatec™ alone provides for a 90% sensitivity in the detection of biopsy-confirmed high grade disease (CIN2+) compared to a 39% sensitivity for the Pap test alone. In addition, the combined use of Cervatec™ with the Pap test is detecting the level of underlying disease anticipated in this population.

Ruediger Ridder, Chief Scientific Officer of mtm laboratories, commented:

"We are pleased with our study outcome, further confirming the unique properties of our proprietary p16 biomarker. Pap tests have served us well for many years but still many women with early disease are missed in screening. We have shown in this study that the combined sensitivity of Pap with Cervatec™ is more than twice as high than when using Pap alone. We therefore believe that the gain in sensitivity of Cervatec™ truly reflects the expected underlying disease that is missed by the Pap Test alone."

Bob Silverman, Chief Commercial Officer of mtm laboratories, added:

"The combination of our easy-to-use Cervatec™ assay with conventional Pap testing represents a major improvement in the screening for cervical cancer and its precursors. The biomarker-based ELISA is an affordable and objective high-throughput approach to detect cancerous disease in first line screening. Cervatec™ will improve the certainty for gynaecologists and patients that severe lesions, which might otherwise remain undetected by Pap testing alone, are detected early when treatment interventions can be most effective."

mtm's In-vitro-Diagnostic tests based on the p16 INK4a biomarker are independent of the viral infection with certain HPV types which lead to a cancerous disease in a very small percentage of infected women. Due to the high prevalence of underlying viral infections and the resulting high rate of false positivity for the infection in younger women who have no evidence of cervical disease, Cervatec™ allows for a much more specific identification of actual disease and is particularly well suited for women aged 35 and younger. For further information, please visit http://www.cervatec.com.

Intended Use

The Cervatec™ Assay is an In-Vitro Diagnostic assay for the quantitative determination of human p16INK4a protein in lysed samples from the cervix uteri. It is indicated to be used in conjunction with conventional Pap cytology testing as an aid to increase the sensitivity for the detection of high-grade cervical intraepithelial neoplasia.

Disclaimer

This IVD product and the use presented herein has not been cleared or approved by authorities in the United States including the United States Food and Drug Administration. mtm's CE-labelled Cervatec™ Assay will be marketed solely outside of the U.S.

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.

http://www.mtmlabs.com

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