Studies Present Compelling Data on The p16(INK4a) Biomarker at The 16th International Congress of Cytology.10 studies at 13-17 May conference in Vancouver confirm sensitivity and specificity of p16(INK4a) as a biomarker for the early detection and diagnosis of cervical cancer Cervical Cancer Definition Cervical cancer is a disease in which the cells of the cervix become abnormal and start to grow uncontrollably, forming tumors. HEIDELBERG, Germany -- mtm laboratories today announced that 10 studies to be presented at the 16th International Congress of Cytology cytology (sītŏl`əjē), in biology, the study of the structure of all normal and abnormal components of cells and the changes, movements, and transformations of such components. (ICC ICC See: International Chamber of Commerce ) confirm the high specificity and sensitivity of the p16INK4a biomarker for cervical dysplasia Cervical dysplasia Dysplasia is the abnormal growth of the epithelial cells. This is what a Pap smear will detect in the cervix. Mentioned in: Pelvic Exam cervical dysplasia . p16INK4a is being used by mtm as a biomarker in their proprietary CINtec([R]) products currently marketed for the early detection and diagnosis of cervical cancer. The ICC, which is currently taking place in Vancouver, Canada, will have a total of 10 abstracts for talks and posters focusing on p16INK4a as a diagnostic tool for cervical cancer, a number of them using mtm's proprietary CINtec([R]) Kits. p16INK4a is known as a surrogate marker surrogate marker Lab medicine A parameter or measured to detect a pathologic condition when a more specific test doesn't exist, is impractical or not cost-effective; surrogate testing has been used for non-A, non-B hepatitis, measuring ALT and antibodies to HBV for the oncogenic oncogenic /on·co·gen·ic/ (-jen´ik) giving rise to tumors or causing tumor formation; said especially of tumor-inducing viruses. on·co·gen·ic or on·cog·e·nous adj. activity of high risk Human Papilloma Virus human papilloma virus n. Abbr. HPV A DNA virus of the genus Papillomavirus, certain types of which cause cutaneous and genital warts in humans, including condyloma acuminatum. (HR-HPV). As such, it offers a highly specific indication of the presence of cervical abnormalities. Papers presented at the conference report research data indicating that p16INK4a offers a very high degree of specificity in early diagnosis that could significantly improve the efficiency and effectiveness of managing cervical abnormalities. In addition a number of papers indicate that tests based on this marker may identify disease in cases that would be missed by traditional methods. This potential for a high level of accuracy, even in the very earliest stages of disease, promises that tests based on this biomarker may allow treatment to start at a point when it will be most effective. "We have been developing tests based on p16INK4a for a number of years and launched our proprietary CINtec[R] Histology and CINtec[R] Cytology Kits in January this year," said Ruediger Ridder, Chief Scientific Officer for mtm laboratories. "The research to be presented at the ICC amply demonstrates that the biomarker used in our diagnostic kits offers a clear and accurate means to aid in identifying cervical cancer in its earliest stages when it is most amenable to treatment." mtm has a significant presence at the ICC this year (Booth 110) and is happy to discuss the unique properties of its CINtec[R] products. A full programme for the conference can be found at http://icc.venuewest.com/ mtm laboratories AG is an ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 9001 and ISO 13485 certified developer and manufacturer of In-Vitro Diagnostic Devices (IVDD IVDD In-Vitro Diagnostic Device (medical) IVDD Intervertebral Disc Disease ) 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 United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , France, Italy and Spain. mtm is currently marketing CINtec[R] Histology and CINtec[R] Cytology for use as an aid in the early detection of cervical cancer. Further information can be found at: www.mtmlabs.com Notes for editors: The CINtec[R] family of diagnostic products mtm's family of products is based on mtm's proprietary E6H4[TM] antibody clone which was specifically developed for immunochemistry Immunochemistry A discipline concerned both with the structure of antibody (immunoglobulin) molecules and with their ability to bind an apparently limitless number of diverse chemical structures (antigens); with the structure, organization, and rearrangement 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 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[R] immunoassays are validated to provide a sensitive and specific method for the detection of p16INK4a in cervical tissues. The currently marketed CINtec[R] In-vitro Diagnostics (IVDs) have been developed for application on: * cervical biopsies (CINtec[R] Histology) and * cervical specimens such as smears and liquid based cytology samples (CINtec[R] Cytology) CINtec[R] products are available on a global basis through mtm's direct operations and distributors. |
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