MTM Laboratories AG Launches Proprietary CINtec(R) Histology And CINtec(R) Cytology Kits

HEIDELBERG, Germany, January 3 /PRNewswire/ -- mtm laboratories today announced the international launch of its CINtec(R) Histology Kit and CINtec(R) Cytology Kit. These kits, which are commercialized as CE-labelled In-vitro diagnostic devices (IVDs) in Europe and Class I IVDs in the US, are based on mtm's proprietary technology for detection of p16INK4a biomarker over-expression in cervical biopsies and cytology preparations.

The kits contain mtm's specifically designed antibody (clone E6H4TM) and customized secondary reagents with protocols, specifically developed and optimized for immunochemistry applications in cervical histology (CINtec(R) Histology) and cytology specimens (CINtec(R) Cytology). mtm is currently running an extensive clinical development program to further clinically validate CINtec(R) Histology and CINtec(R) Cytology assays and to validate their potential role for improving histological diagnosis and cytology interpretation.

The CINtec(R) products, commercialized under mtm's former licensee Dako A/S up until end of 2006, are easy-to-use standardized kits that add biomarker information while maintaining morphology. The CINtec(R) products will now be available globally through mtm's direct operations and distributors.

"Early detection of cancer and pre-cancerous disease is by far the most efficient and effective strategy to successfully fight cancer, but standard diagnostics have unacceptably high levels of inaccuracy" commented Robert Silverman, Chief Commercial Officer (CCO) of mtm laboratories. "There is a strong demand for new markers which are highly accurate for finding high grade disease"

"Since the technology uses a recognized biomarker which is the first marker of cervical cell response to HR-HPV oncogene transformation being independent of HR-HPV type and independent of age, our test will add confirmation to the diagnosis and save lives", added Ruediger Ridder, CSO of mtm laboratories.

The transfer of sales and marketing responsibilities for all CINtec(R) products from Dako to mtm laboratories came into effect at the start of January 2007. This follows the restructuring of the former licensing agreement with Dako, which was terminated by mtm, as previously announced on May 2 2006.

mtm laboratories AG is an ISO 9001 and ISO 13485 certified developer and manufacturer of In-Vitro Diagnostics (IVD) 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(TM) Assay.