FDA Approves Expanded Use of CINtec PLUS Cytology Assay for Women Testing Positive for High-Risk HPV

The FDA has approved the expanded use of the CINtec PLUS Cytology assay for women who undergo cervical cancer screening and test positive for high-risk types of human papillomavirus (HPV), according to an announcement from Roche.¹ The test is capable of identifying the presence of p16 and Ki-67 simultaneously. If a single cell expresses both of these biomarkers, there is a higher likelihood that the patient will have transforming HPV infection capable of progressing to either pre-cancer or cancer.

The regulatory decision was based on findings from the registrational IMPACT trial, for which publication of the full data is pending, according to Roche. In the trial, investigators examined the CINtec PLUS Cytology test as a triage tool in several screening scenarios among a population of over 35,000 women. The approval for expanded use provides laboratories with access to the complete Roche Cervical Cancer Portfolio in the United States; this is comprised of the cobas HPV test, CINtec PLUS Cytology, and CINtec Histology.

“With our portfolio of cervical cancer tests and automated testing platforms, we are committed to providing clinicians and laboratories with the best tools possible to protect women’s health,” Thomas Schinecker, CEO of Roche Diagnostics, stated in a press release. “This expanded indication for CINtec PLUS Cytology gives laboratories the flexibility to triage cobas HPV test results on their choice of cobas Systems and deliver accuracy needed to reliably detect HPV infections that are starting to cause cellular changes that could lead to cancer. The biomarker information helps to clarify a women’s risk of disease, reduce the potential for over- or under-treatment, and is a major step forward in individualizing a woman’s care.”

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