Study of CINtec® PLUS in the management of Pap negative but HPV positive women published

Paper in Gynecologic Oncology shows that p16/Ki-67 dual staining can pinpoint those women that need immediate follow-up

Heidelberg, Germany - mtm laboratories announced the publication of study results showing that the CINtec® PLUS kit for dual staining of p16 and Ki-67 is an effective tool with high sensitivity and specificity to identify high-grade cervical disease among women tested negative for Pap abnormalities but positive for HPV. The paper, which details these study results, has been published electronically in Gynecologic Oncology  on March 21, 2011 ahead of print.

Co-testing for HPV adjunctively with Pap cytology has been proposed as a way to improve the sensitivity of cervical cancer screening in women aged 30 years or older. Women that have no Pap abnormalities but are positive for HPV are followed up, typically in 6-12 months. While co-testing with HPV does increase the sensitivity of the screening, it creates a management dilemma for the clinician and unnecessary anxiety for the patient, because only a fraction of women aged 30 or older who test positive for HPV will harbour high-grade cervical disease.

In the now published study, conducted as part of a major screening project in Wolfsburg, Germany, 425 out of 7,976 women participating in this pilot Pap/HPV co-testing project in 2007/2008 tested HPV positive when the Pap test was negative. These women were then managed with repeat testing and subsequent colposcopies and biopsies as clinically indicated. These same cases were also tested with CINtec® PLUS, and the results for the detection of adjudicated biopsy confirmed high-grade disease were determined. CINtec® PLUS at baseline detected 91.9% of the CIN2+ cases and 96.4% of the CIN3+ cases; a high yield for established disease. 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 the 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:

“Our researched showed that the CINtec® PLUS  kit delivers high sensitivity with high specificity in accurately identifying the women likely to harbor high-grade disease that need immediate medical follow up. HPV testing may improve the sensitivity aspect for cervical cancer screening but at the high cost of excessive false positive results. This leaves many women with the uncertainty of their health status or being sent for unnecessary follow up. The key point is that our dual staining test can identify fraction of women in this patient group that benefit most from immediate medical follow up.” 

The title of the publication and the lead author is as follows:

Petry KU, et al, Triaging Pap cytology negative, HPV positive cervical cancer screening results with p16/Ki-67 Dual-stained cytology, Gynecol Oncol (2011), doi:10.1016/j.ygyno.2011.02.033

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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.