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mtm laboratories Opens Subsidiaries in Italy, France and Spain to Support the Commercialization of Its Diagnostic Products.


HEIDELBERG, Germany -- mtm laboratories today announced the opening of new subsidiaries by the Company in Italy (Milan), France (Paris) and Spain (Madrid) in order to commercialize its CE-labeled diagnostic products in Europe. When combined with Germany, these additional European markets represent approximately 65% of the total European 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.
 screening market.

Peter Pack, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of mtm laboratories commented, "Our commitment to expanding into France, Italy and Spain, along with our existing presence in Germany and the USA, signals our intention to make mtm's cervical cancer diagnostic products globally available."

Through these new subsidiaries, mtm will commercialize its proprietary p16INK4abased a·base  
tr.v. a·based, a·bas·ing, a·bas·es
To lower in rank, prestige, or esteem. See Synonyms at degrade.



[Middle English abassen, from Old French abaissier
 products in major European markets starting in January 2007. As announced in May 2006, mtm regained the rights to commercialize its CINtec[R] products after it had terminated its exclusive license to Dako A/S (Denmark), effective January 1 2007. mtm's CINtec([R]) in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment.

in vi·tro
adj.
In an artificial environment outside a living organism.
 diagnostic products focus on the detection of p16INK4a over-expression in biopsies (CINtec([R]) Histology) and cervical 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.  specimens (CINtec([R]) Cytology) while retaining cellular morphology. In parallel, the company is developing the biochemical product Cervatec[TM] ELISA ELISA (e-li´sah) Enzyme-Linked Immuno-Sorbent Assay; any enzyme immunoassay using an enzyme-labeled immunoreactant and an immunosorbent.

ELISA
n.
, an assay not reliant on the integrity and assessment of cells.

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 Diagnostics (IVD (Interactive VideoDisc) See interactive video. ) for the screening 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. mtm laboratories is in the process of developing and clinically validating the cell-based CINtec([R]) Assays as well as the biochemical Cervatec[R] ELISA Assay.

Notes for editors:

Cervical cancer

Worldwide, cervical cancer is the second most common cancer in women, a position it shares with colorectal cancer. Globally, about 500,000 new cases of cervical cancer are diagnosed annually, and are associated with over 200,000 deaths. Prevention of cervical cancer is fundamentally tied to the early detection of the disease at the stage of pre-cursor lesions. If diagnosed early, cervical cancer can be virtually 100% prevented. The screening for, and early detection of cervical cancer is considered the most efficient and effective strategy to for cancer prevention.

Standard diagnostics and screening for cervical cancer

The mainstay of cervical cancer screening is the Pap Test. The Conventional Pap Smear (CPS) has been in widespread use since the 1950's and is credited with a significant reduction in cervical cancer cases and mortalities. However, this "old" technology has well defined limitations in sensitivity, specificity and test quality. These limitations have in part been addressed by Liquid Based Cytology (LBC LBC Luton Borough Council
LBC Liquid Based Cytology
LBC Lebanese Broadcasting Corporation
LBC Lancaster Bible College (Pennsylvania)
LBC Long Beach California
LBC Long Beach City
LBC Albanian Airlines
) products which were introduced in the mid-1990s. Despite recent advances in cytology technologies, the current screening system remains heavily reliant on human interpretation of cellular changes resulting in the continued clinical need for improvement in sensitivity, specificity and diagnostic efficiency.

More recently, testing for 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.
 (HPV HPV human papillomavirus.

HPV
abbr.
human papilloma virus


Human papilloma virus (HPV) 
) has been adopted for the management of unclear and mildly abnormal Pap Tests (most of which are false positive results) for women over 35. Its use for this application is limited to less than 3% of all Pap Tests. In addition, clinical studies are in process to gain utilization for HPV testing in a primary screening mode. The sensitivity for disease of HPV testing is superior to that of a Pap Test. However, the high rate of general HPV infection for this virus in women (up to 25%) delivers a very low specificity (correlation of positive test to actual disease), which severely limits the potential clinical utility of this for mainstream screening.

The CINtec[R] family of screening and diagnostic products

mtm's products for cervical cancer are based on the detection of a highly specific biomarker, p16INK4a, which indicates the existence of pre-cancerous and cancerous cervical cells. The identification and clinical validation of this biomarker, has enabled mtm to develop assays, for use in population-wide screenings, to detect and to diagnose cancer at an early stage when it is most treatable.
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Publication:Business Wire
Date:Jan 4, 2007
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