mtm laboratories Inc. Presenting at JP Morgan Healthcare Conference, January 12 2011
Published: Jan 10, 2011
The presentation will focus on mtm’s technology platform, business, and its novel marketed products including CINtec® PLUS C ytology (dual staining for p16 and Ki-67), which was launched in Europe in March, 2010. The product has been evaluated in 3 large European clinical trials in over 32,000 women. The significant results achieved in these trials demonstrate that CINtec® PLUS Cytology delivers both high sensitivity and high specificity for underlying cervical disease. These trials support a CE Mark with claims for 1) primary screening, 2) the triage of ASC-US and LSIL cytology results, and 3) the management of HR-HPV positive results when the Pap test is negative.
The basis of mtm's IVD products, the proprietary p16INK4a biomarker, is strongly over-expressed in pre-cancerous and cancerous cells of the cervix. Screening and diagnostic tools based on this biomarker are developed to improve the accuracy and efficiency for the screening and early diagnosis of cervical cancer. mtm's CINtec® in vitro diagnostic products focus on the detection of p16INK4a over-expression in biopsies (CINtec® Histology) and cervical cytology specimens (CINtec® PLUS Cytology).
In the US these products are available as Class 1 IVDs without claims. The clinical performance, as described in this press release and as investigated in the cited studies, have not been cleared or approved by the United States Federal Food and Drug Administration.
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.
Bob Silverman CEO mtm laboratories AG t: +1 508-366-8334 e: email@example.com
Dr. Douglas Pretsell Associate Partner College Hill t : +44 (0)207 866 7868 e: firstname.lastname@example.org