FDA Approves Cytology Test to Enhance Cervical Cancer Prevention

The FDA has approved the CINtec PLUS Cytology test as the first biomarker-based triage test for women whose primary cervical cancer screening results are positive for the human papillomavirus using the cobas 4800 HPV Test.

The FDA has approved the CINtec® PLUS Cytology test as the first biomarker-based triage test for women whose primary cervical cancer screening results are positive for the human papillomavirus (HPV) using the cobas® 4800 HPV Test, according to Roche (Genentech), the manufacturer of the test.1

The CINtec PLUS Cytology test allows clinicians to identify HPV-positive women who are more at risk of developing cervical precancers, identifying those patients who need to immediately receive additional diagnostic work.

“Despite being nearly 100% preventable, cervical cancer is still 1 of the most common cancers in women worldwide. To address this, Roche is dedicated to investing in next-generation biomarkers that will significantly advance screening strategies and support global efforts to eradicate this disease,” Thomas Schinecker, CEO, Roche Diagnostics, said in a press release. “We are committed to providing women with the protection and care they deserve.”

The CINtec PLUS Cytology simultaneously detects p16 and Ki-67. When a cell expresses

both of these biomarkers, there is a high likelihood that the patient has transforming HPV infections that can potentially progress to either precancer or cancer.2

In making its decision, the FDA reviewed data from the registrational IMPACT (IMproving Primary screening And Colposcopy Triage) trial, which have not yet been published, according to Roche. The study evaluated the CINtec PLUS Cytology test as a triage tool in several screening scenarios among a population of more than 35,000 women.

Previous research demonstrated the potential of the CINtec PLUS Cytology test. One study was a retrospective analysis that compared CINtec PLUS Cytology with Pap cytology triage in HPV-positive test results from a subset of 7727 women aged ≥25 years enrolled in the ATHENA trial.3 All of these patients had a valid cervical biopsy and cobas HPV Test results, and had been referred to colposcopy. The investigators were able to retrospectively conduct p16/Ki-67 dual-stained cytology using residual cytologic material collected at the time the patients were enrolled on the ATHENA trial.

The study showed increased sensitivity with the CINtec PLUS Cytology test at 74.9% compared with 51.9% with Pap cytology (P <.0001). The specificity rates were comparable at 74.1% versus 75%, respectively (P = .3198).

The PALMS study assessed CINtec PLUS Cytology in 27,349 women aged ≥18 years across 5 countries in Europe who received routine screening for cervical cancer.4 All women received HPV testing, pap cytology and p16/Ki-67 immunostaining with CINtec PLUS Cytology. Women with positive test results were referred for colposcopy, with the exception of women aged <30 years who only tested positive for HPV.

The investigators observed similar rates of p16/Ki-67 dual-stained cytology positivity as the incidence of abnormal Pap cytology results. The p16/Ki-67 positivity rates were <50% of the HPV+ testing rates.

Across all women, the sensitivity of CINtec PLUS Cytology was higher than Pap cytology at 86.7% versus 68.5% (P <.001) for detecting high-grade cervical intraepithelial neoplasia, the study’s criterion for referral for colposcopy; the specificity, as with the ATHENA substudy data, were comparable at 95.2% versus 95.4%, respectively (P = .15).

Roche anticipates that later this year, CINtec PLUS Cytology will be commercially available in the United States on a widespread basis.


  1. Roche receives FDA approval for CINtec PLUS Cytology test to aid clinicians in improving cervical cancer prevention. Published online March 11, 2020. https://bit.ly/2IEgWc5. Accessed March 11, 2020.
  2. CINtec® PLUS Cytology. Roche. Last updated March 11, 2020. https://diagnostics.roche.com/global/en/products/tests/cintec-plus.html. Accessed March 11, 2020.
  3. Wright TC Jr, Behrens CM, Ranger-Moore J, et al. Triaging HPV-positive women with p16/Ki-67 dual-stained cytology: Results from a sub-study nested into the ATHENA trial. Gynecol Oncol. 2017;144(1):51-56. doi: 10.1016/j.ygyno.2016.10.031.
  4. Ikenberg H, Bergeron C, Schmidt D, et al. Screening for cervical cancer precursors with p16/Ki-67 dual-stained cytology: results of the PALMS study. J Natl Cancer Inst. 2013;105(20):1550-1557. doi: 10.1093/jnci/djt235
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