HEIDELBERG, Germany--(BUSINESS WIRE)--mtm laboratories, a fully integrated cancer diagnostics company with proprietary products marketed globally, today announced the launch of the CE-labeled CINtec® Cytology kit with extended claims for the diagnosis of cervical cancer in Europe. The clinical claims are derived from the outcome of a recent pan-European pivotal study involving pathologists and cytotechnologists from France, England, Spain, Italy and Germany.
The multi-center trial was conducted to determine the sensitivity and specificity for the detection of underlying high grade disease for women with ASC-US (equivocal) or Low Grade (mild abnormality) cytology results to High Risk HPV (HR-HPV) testing. The overall sensitivity for the detection of CIN2 and higher grade disease exceeded 92%, which was essentially the same as that of HR-HPV testing. However, the specificity of CINtec Cytology was 67-100% higher than that of HR-HPV testing.
Ruediger Ridder, CSO of mtm laboratories, commented:
“Equivocal or mild results such as those examined in the study are clinically relevant since a portion of these actually harbour high grade disease, the immediate pre-cursor to Cervical Cancer, and as such cannot be ignored. However, it is costly and inefficient to treat or manage all of the cases based on the initial cytology finding, which is why a more accurate biomarker-based test such as CINtec® Cytology is needed to pinpoint those cases where there is high grade disease.”
Bob Silverman, CEO of mtm laboratories, commented:
"Approximately 6-8% of Pap Test results will be equivocal or mildly abnormal. While the majority of these diagnoses are benign, 10-15% of these cases will harbour high grade disease creating a clinical dilemma for clinicians. The results of this trial demonstrate that CINtec Cytology can more accurately identify those women with high grade disease than managing these cases with HR-HPV testing. This is a major advance in cervical cancer screening, and for the women participating in screening programs."
The CINtec ® Cytology Kit is an immuno-cytochemistry assay for the qualitative detection of the p16INK4a antigen on cervical cytology preparations. It is intended to be used as an aid in the identification of women with underlying high-grade cervical intraepithelial lesions in the sub-group of patients with a Pap cytology result of ASC-US (atypical squamous cells of undetermined significance) or LSIL (low grade intraepithelial lesion).
mtm's CE-labeled CINtec® Cytology 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, Spain and Japan. Further information can be found at: www.mtmlabs.com.
mtm laboratories AG
Bob Silverman, CEO
t: +1 508 366 8334
Dr. Douglas Pretsell
Account Director, Munich Bureau Chief
t : +49 (0)89 57 00 18 06
Source: mtm laboratories