(RTTNews) – Swiss drug maker Roche Group (RHHBY) announced Wednesday that the U.S. Food and Drug Administration has approved the expanded use of CINtec PLUS Cytology test to aid clinicians in preventing cervical cancer.
It is the first triage test based on biomarker technology for women whose cervical cancer screening results are positive for high-risk types of human papillomavirus or HPV, the principal cause of cervical cancer. Roche noted that additional information from this test supports clinical decisions about which women will benefit most from immediate follow-up.
With the approval, 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.
Thomas Schinecker, CEO Roche Diagnostics, said, “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.”
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