CINtec PLUS Cytology is a biomarker-based triage test that simplifies clinical decision making through its easy to understand results
Roche secures FDA approval for CINtec PLUS Cytology to test cervical cancer (Credit: F. Hoffmann-La Roche Ltd.)
Roche has obtained the US Food and Drug Administration (FDA) approval of CINtec PLUS Cytology test for women tested positive for the human papillomavirus (HPV) using its cobas 4800 HPV test.
The cobas 4800 System will fully automate the cobas HPV sample preparation with real-time polymerase chain reaction (PCR) technology for amplification and detection.
Approved as the first biomarker-based triage test, CINtec PLUS Cytology test has been designed to simplify clinical decision making, through its easy to understand results, said the company.
Roche Diagnostics CEO Thomas Schinecker said: “Roche is dedicated to investing in next-generation biomarkers that will significantly advance screening strategies and support global efforts to eradicate this disease. 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.”
FDA approval for CINtec PLUS Cytology is based on IMPACT clinical trial
The CINtec PLUS Cytology test will identify women whose HPV infections, which are likely to be associated with cervical pre-cancers, and enables clinicians to refer them for immediate further diagnostic procedures, to prevent them from developing more advanced cervical disease.
According to the American Cancer Society, persistent HPV infection is the main cause of cervical cancer, where the virus is associated in more than 99% of cervical cancers across the world.
The company said that its CINtec PLUS Cytology will offer complete information about which HPV-positive women may benefit most from immediate referral to colposcopy, than repeat testing. The test offers personalised care for women and prevents both overtreatment and undertreatment.
Data from the Roche’s improving primary screening and colposcopy triage (IMPACT) trial, which enrolled more than 35,000 women, has supported the FDA approval of CINtec PLUS Cytology as a triage test.
The company is planning to commercialise its new CINtec PLUS Cytology in the US, later in 2020.