mtm laboratories, a fully integrated cancer diagnostics company
with proprietary products marketed globally, today announced the
launch of the CE-labeled CINtec(R) Histology kit with extended claims
in Europe. The clinical claims are deduced from the outcome of a
recent pan-European pivotal study involving 15 pathologists from
France, Spain, Italy and Germany.
The multi-center trial was conducted to determine the diagnostic
accuracy of pathologists in reading H&E stained cervical biopsies
together with CINtec(R) Histology stained slides, compared to reading
H&E slides alone, on 500 retrospectively collected cervical tissue
specimens. The specimen collection comprised punch and conization
biopsies with a distribution of cases of Negative for Dysplasia, CIN1,
CIN2 and CIN3.
Ruediger Ridder, CSO of mtm laboratories, explained the outcome:
"The overall sensitivity for the detection of CIN2 and higher
grade disease was improved by 13%, with a 95% sensitivity for
detection of high grade disease (CIN3), whereas the number or false
negative results dropped by 45%. In addition, the inter-observer
agreement, which is higher by 30%, improves the certainty that the
result is consistent among different reviewers."
Peter Pack, CEO of mtm laboratories, commented:
"The clinical performance of the CINtec(R) Histology kit, which
was fully developed by mtm and which is produced in-house,
impressively confirms numerous findings in literature that p16INk4a is
a highly sensitive marker for the presence of dysplastic and
neoplastic cells in specimens of the cervix uteri. The CINtec(R)
Histology study results support the routine use of CINtec(R) Histology
in the diagnosis of cervical biopsies. CINtec(R) Histology improves
clarity and confidence for detecting cervical cancer and its
precursors based on an objective parameter".
The CINtec (R) Histology Kit is indicated to be used in
conjunction with H&E stained slides prepared from the same cervical
tissue specimen as an aid to increase diagnostic accuracy and
inter-observer agreement in the diagnosis of high-grade cervical
intraepithelial neoplasia and cervical carcinoma.
mtm's CE-labeled CINtec(R) Histology kit with extended claims will
be marketed solely outside of the U.S.
Disclaimer: This IVD product and the use presented herein has not
been cleared or approved by authorities in the United States including
the United States 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 operates on a global basis with the headquarter in Heidelberg,
Germany and subsidiaries in the United States, France, Italy and
Spain. 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
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 of the 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 cytology preparations 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.
