mtm’s CINtec PLUS, p16/Ki-67 dual staining kit, delivers new solution to manage Pap negative ...
mtm’s CINtec PLUS, p16/Ki-67 dual staining kit, delivers new solution to manage Pap negative but HPV positive women
Study results presented at EFC Congress, Berlin 27-29 May 2010
Heidelberg, Germany- May 27, 2010- mtm laboratories today announced the results of a study that showed dual staining for p16 and Ki-67 in a single test was capable of identifying the underlying cases with high-grade disease among those women tested negative for Pap abnormalities but positive for HPV. This study used the CINtec® PLUS kit that was launched by mtm on March 8 2010 in Europe and the results will be presented on Saturday 29th May at the 5th European Congress of the European Federation for Colposcopy and Cervical Pathology in Berlin.
Co-testing for HPV adjunctively with Pap cytology has been proposed as a way to improve the sensitivity of cervical cancer screening in women over 30 years of age. In this scenario, all women that have no Pap abnormalities but are positive for HPV are followed up. While this does increase the sensitivity of the testing, only a fraction of women over 30 who test positive for HPV will harbour high-grade cervical disease.
In the study, conducted in Wolfsburg, Germany, 427 women out of 7,976 in a prospective cervical cancer screening study tested HPV positive when the Pap Test was negative. These women were then managed with repeat testing and colposcopic examinations and biopsies as clinically indicated. These same cases were tested with CINtec® PLUS, and the results for the detection of adjudicated biopsy confirmed high-grade disease were determined. CINtec® PLUS detected 91.9% of the CIN2+ cases and 96% of the CIN3+ cases. Importantly, it was able to show this high level of sensitivity with a very high degree of specificity as only one fourth of these cases tested positive for dual stain. In addition, a negative result for the dual stain had a very high negative predictive value; 99.1%.
Bob Silverman, CEO of mtm laboratories commented:
“HPV testing can increase the sensitivity of cervical cancer screening but the price for this improvement is a significant reduction in specificity which can result in substantially increasing the levels of unnecessary follow up visits and procedures. Our CINtec® PLUS kit delivers high sensitivity with high specificity in accurately identifying the women likely to harbor high-grade disease thus requiring immediate follow up. And, with CINtec® PLUS, this level of disease detection can be done by focusing on only 25% of the positive cases and thus triaging 75% of women back to repeat routine testing.”
The title and authors of the presentation are as follows:
TRIAGING PAP NEGATIVE, HPV POSITIVE CERVICAL CANCER SCREENING TEST RESULTS BY p16/Ki-67 DUAL STAINED CYTOLOGY
Luyten A, Scherbring S, Reinecke-Lüthge A, Schmidt D, Ridder R, Petry KU
Department of Gynecology and Obstetrics, Klinikum der Stadt Wolfsburg, Germany Institute of Clinical Pathology, Klinikum der Stadt Wolfsburg, Germany; Institute for Pathology, A2.2, Mannheim, Germany; mtm laboratories, Heidelberg, Germany
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About mtm laboratories AG
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 headquarters in Heidelberg, Germany and subsidiaries in the United States, France, Italy and Spain. Further information can be found at: www.mtmlabs.com
In the US the product is available as a Class 1 IVD without claims. The utility 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
t: +1 508-366-8334
Dr. Douglas Pretsell
t : +49 (0)89 57 00 18 06
Notes for editors
CINtec® PLUS is a screening tool combining high sensitivity and high specificity for detecting high-grade cervical disease in a single test. The CINtec® PLUS kit detects and stains for two biomarkers: the multiply validated cell cycle regulatory protein p16INK4a (p16) and Ki-67, a marker of active cell proliferation. Clinical trials involving over 32,000 women have demonstrated that when used together, this biomarker combination is both highly sensitive and highly specific to identify those women most likely to have existing high–grade disease. Moreover, the CINtec® PLUS test is independent of age and HR-HPV type of infection.
Applied in combination the co-detection of p16 plus Ki-67 in the same cell serves as an indicator of cell cycle de-regulation that occurs during HR-HPV induced oncogenic transformation and provides an objective criterion to identify those women who are likely to harbour high-grade disease. CINtec® PLUS can be applied on conventional and liquid based cytology slides. Double immuno-reactive (or: Dual-stained) cells in cytology are positively stained for both proteins:
· Brown cellular staining indicates p16 over-expression
· Red nuclear staining indicates Ki-67 expression
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