FDA approves Roche HPV test add-on for identifying women with higher risk of cervical cancer

Roche Diagnostics Indianapolis
Used in combination with Roche’s cobas 4800 HPV Test, the CINtec PLUS Cytology test will help delineate which women may benefit most from a subsequent colposcopy compared to repeat testing. (Roche)

The FDA approved Roche’s diagnostic for triaging women whose primary cervical cancer screenings have tested positive for the human papillomavirus (HPV). The company’s CINtec PLUS Cytology test is designed to identify women with HPV infections who are most likely to develop cervical pre-cancers.

Roche describes the product as the first biomarker-based triage test in this area, with the goal of making it easier for physicians and patients to decide the next steps following an initial positive result, such as ordering referrals for further diagnostic procedures.

The company estimates that about 13,800 new cases of invasive cervical cancer will be diagnosed in the U.S. over the course of this year, with HPV as the main cause. Additionally, some women with HPV infections and inconclusive co-testing results, such as a negative Pap cytology test, may still develop precancerous lesions.

“Despite being nearly 100 percent preventable, cervical cancer is still one of the most common cancers in women worldwide,” Roche Diagnostics CEO Thomas Schinecker said in a statement. “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.” 

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Used in combination with Roche’s cobas 4800 HPV Test, the CINtec PLUS Cytology test will help delineate which women may benefit most from a subsequent colposcopy compared to repeat testing.

The dual-stain test—which employs the same liquid sample used for HPV or Pap testing, on the company’s BenchMark ULTRA IHC/ISH system—looks for two biomarkers associated with HPV infections that are actively transforming and could drive cancer progression. 

Previously used as a triage test in Europe, Asia, South America and Australia, Roche said it expects to make the test widely available in the U.S. later this year.