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 p16INK4a as a biomarker for
the early detection and diagnosis of cervical cancer
Heidelberg, Germany, May 15, 2007 -
mtm laboratories today announced that 10
studies to be presented at the 16th International Congress of Cytology (ICC)
confirm the high specificity and sensitivity of the p16INK4a biomarker for
cervical dysplasia.
p16INK4a is being used by mtm
as a biomarker in their proprietary CINtec®
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® Kits.
p16INK4a is known as a surrogate marker for the
oncogenic
activity of high risk Human Papilloma
Virus (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®
Histology and CINtec®
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®
products. A full programme for the conference can be found at
http://icc.venuewest.com/
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 anddiagnosis
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
is currently marketing CINtec®
Histology and CINtec®
Cytology for use as an aid in the early detection of cervical cancer. Further
information can be found at: www.mtmlabs.com
Further Information:
Dr. Peter Pack
CEO
mtm
laboratories AG
t: +49 (0)6221 6496 60
e: contact@mtmlabs.com
Dr. Douglas Pretsell
Account Director, Munich Bureau Chief
Northbank Communications
t: +49 (0)89 57 00 18 06
e: d.pretsell@northbankcommunications.com
Notes for editors:
The CINtec® family of diagnostic products
mtm's family of products is based on mtm's proprietary E6H4™ antibody clone
which was specifically developed for immunochemistry 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® immunoassays are validated to provide a sensitive and specific
method for the detection of p16INK4a in cervical tissues. The currently
marketed CINtec® In-vitro Diagnostics (IVDs) have been developed for
application on:
cervical biopsies (CINtec® Histology) and
cervical specimens such as smears and liquid based cytology samples (CINtec®
Cytology)
CINtec® products are available on a global basis through mtm's direct
operations and distributors.
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further information on this release or on mtm laboratories, please don’t
hesitate to contact me on +49 (0)89 57 00 18 06.