- Next-generation biomarker cytology test supports World Health Organization’s goal to eliminate cervical cancer, which is nearly 100 percent preventable with proper screening, vaccination and treatment
- New indication allows this first FDA-approved biomarker-based test to be used as triage for positive cobas HPV tests run on cobas 6800/8800 Systems in primary screening or co-testing programs
- More sensitive than traditional Pap cytology, this test allows clinicians to determine which HPV-positive women require further diagnostic procedures to prevent disease progression
Basel, 16 September 2020 — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval for 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). Additional information from this test supports clinical decisions about which women will benefit most from immediate follow-up. Laboratories can now use CINtec PLUS Cytology to triage positive results from the cobas® HPV Test run on the fully integrated, automated and high-throughput cobas® 6800/8800 Systems.
High-risk HPV is the principal cause of cervical cancer, which is one of the most common cancers in women globally. The World Health Organization has set goals for countries to take action to eliminate cervical cancer by 2030.
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,
said Thomas Schinecker, CEO Roche Diagnostics.
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 individualising a woman’s care.
HPV DNA screening identifies women at risk for cervical cancer by detecting the presence of high-risk HPV DNA in cervical samples. While most HPV infections resolve on their own, some women who test positive for the virus, or whose co-testing results are discrepant (HPV positive/Pap cytology negative), may have or may develop pre-cancerous cervical lesions. These lesions could progress to cervical cancer if left untreated.