FDA Expands Use of CINtec PLUS Cytology Test for Women who are HPV-Positive

September 16, 2020

Researchers suggested this test “helps to clarify a woman’s risk of disease, reduce the potential for over- or under-treatment, and is a major step forward in individualizing a woman’s care.”

The FDA has approved the expanded use of CINtec PLUS Cytology, the first triage test based on biomarker technology for women whose cervical cancer screening results are positive for high-risk types of human papillomavirus (HPV), according to Roche, the developer of the test.

The CINtec PLUS Cytology test allows clinicians to determine which women who are found to be HPV-positive require further diagnostic procedures. Laboratories may now use the biomarker-based test to triage positive results from the cobas HPV Test run on the fully integrated, automated and high-throughput cobas 6800/8800 Systems.

“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 at Roche Diagnostics, said 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 woman’s risk of disease, reduce the potential for over- or under-treatment, and is a major step forward in individualizing a woman’s care.”

The CINtec PLUS Cytology test is performed using the same sample that is used for HPV or liquid-based Pap cytology tests. Further, the test detects the simultaneous presence within a single cell of the 2 biomarkers, p16 and Ki-67.

The FDA approval was supported by data from the registrational IMPACT (Improving Primary screening And Colposcopy Triage) trial. Overall, approximately 35,000 women in the US were enrolled to clinically validate CINtec PLUS Cytology as a triage test in various screening scenarios.

Notably, prior to FDA approvals for its use for the triage of women who are HPV positive using the cobas HPV Test on the cobas 4800 or cobas 6800/8800 systems, the CINtec PLUS Cytology CE-IVD test had been used as a triage test for HPV-positive results and mildly abnormal Pap cytology results in Europe, Asia, South America, Canada, and Australia.

Reference:

Roche receives FDA approval for expanded use of the CINtec PLUS Cytology test to aid clinicians in preventing cervical cancer [news release]. Basel. Published September 16, 2020. Accessed September 16, 2020. https://www.roche.com/media/releases/med-cor-2020-09-16.htm