Heidelberg, Germany – mtm laboratories, a fully integrated cancer diagnostics company with proprietary products marketed globally, today announced the publication of a large study in the July issue of the American Journal of Clinical Pathology that evaluated the clinical performance of the CE-labeled CINtec® Cytology kit in managing equivocal or mildly abnormal cytologic results.
The publication authored by Denton and colleagues and titled
”The Sensitivity and Specificity of p16INK4a Cytology vs. HPV Testing for Detecting High-Grade Cervical Disease in the Triage of ASC-US and LSIL Pap Cytology Results”
shows that the interpretation of p16 cytology slides has the potential to provide a high sensitivity, with significantly higher specificity for the identification of high-grade CIN than High-risk Human Papillomavirus (HR-HPV) testing for the management of women with Pap cytology results categorized as ASC-US (Atypical Squamous Cells of Undetermined Significance) or LSIL (Low-grade Squamous Intraepithelial Lesion). These two Pap cytology categories are particularly difficult to interpret but cannot be dismissed as the majority of cases are benign, however, up to 15 % of women with such a cytology result harbor high-grade CIN disease, the immediate pre-cursor to cervical cancer.
The performance of p16INK4a immuno-cytochemistry (p16 Cytology) and HPV testing was analyzed on a series of 810 retrospectively collected ASC-US and LSIL cases. The diagnostic performance of each test was compared using the disease end point of biopsy confirmed high-grade disease (CIN2+). The sensitivity (i.e. ability to find established disease) of the two tests identifying CIN2+ was similar (p16 Cytology, up to 92.6% in ASC-US, and up to 92.2% in LSIL, vs. HPV testing found at 90.1% in ASC-US, and 95.7% in LSIL). However, the specificity of p16 Cytology was up to two times higher than that of HPV testing. This means that significantly less women would need to be sent on for further diagnostic follow-up, while still being able to identify those with established high-grade disease.
Bob Silverman, CEO of mtm laboratories, commented:
“It is important to identify women within the screening program who are most likely to harbor high-grade disease with the least amount of intervention. The results of this study published in this peer review journal show that CINtec Cytology may set a new performance standard for the triage of both ASC-US and LSIL Cytology results.”
Denton KJ, Bergeron C, Klement P, Trunk MJ, Keller T, Ridder R, for the CINtec Cytology Study Group. The Sensitivity and Specificity of p16INK4a Cytology vs HPV Testing for Detecting High-Grade Cervical Disease in the Triage of ASC-US and LSIL Pap Cytology Results.
Am J Clin Pathol 2010;134:12-21
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Disclaimer:
In the US the CINtec® Cytology Kit is available as a Class 1 IVD without claims. The use as described in this press release and as investigated in the cited study 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 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.
Notes for editors:
The CINtec® family of diagnostic products
mtm’s family of products is based on mtm’s proprietary E6H4TM 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 Papillomavirus (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.
mtm have developed two kits that 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® Histology) and cytology specimens (CINtec® Cytology). More recently, mtm has launched CINtec® PLUS, a screening and diagnostic tool that is based on the co-detection of p16 plus Ki-67 (a proliferation marker) that combines unparalleled high sensitivity and high specificity for detecting high-grade cervical disease in a single test.