Roche (OTC: RHHBY) today announced US Food and Drug Administration (FDA) approval of CINtec® PLUS Cytology 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. This biomarker technology simplifies clinical decision making by providing easy to understand results so that clinicians and women are clear on next steps.
The CINtec PLUS Cytology test identifies those women whose HPV infections are most likely to be associated with cervical pre-cancers. It enables clinicians to more confidently determine which women should be referred to immediate further diagnostic procedures, helping to prevent women from developing more advanced cervical disease.
About 13,800 new cases of invasive cervical cancer will be diagnosed in the US in 2020, according to the American Cancer Society, and about 4,290 women will die from the disease this year. Persistent infection with HPV is the principal cause of cervical cancer, with the virus implicated in more than 99 percent of cervical cancers worldwide.
"Despite being nearly 100 percent preventable, cervical cancer is still one 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," said Thomas Schinecker, CEO, Roche Diagnostics. "We are committed to providing women with the protection and care they deserve." While most HPV infections resolve on their own, some women who test positive for the virus or whose co-testing results are inconclusive – HPV-positive and Pap cytology-negative – may develop pre-cancerous cervical lesions that, if left untreated, may progress to cervical cancer. Early identification of women who are most at risk is vital.
CINtec PLUS Cytology provides definitive information about which HPV-positive women may benefit most from immediate referral to colposcopy versus repeat testing. This is a major step forward to individualize a woman's care and prevent both overtreatment and undertreatment.
FDA considered data from the Roche-sponsored registrational IMPACT (IMproving Primary screening And Colposcopy Triage) trial, which enrolled more than 35,000 women in the US to clinically validate CINtec PLUS Cytology as a triage test in different screening scenarios. Publication of study data is pending.
CINtec PLUS Cytology is expected to be widely commercially available in the US later in 2020.