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FDA Approves Biomarker Test for High-Risk HPV-Related Cervical Cancer Risk

Wednesday, September 16, 2020
The FDA approved the CINtec PLUS Cytology test to help determine if HPV-positive women need further diagnostic procedures to prevent cervical cancer, thus contributing to the World Health Organization’s (WHO) goal of irradicating the disease by 2030, according to Roche, the manufacturer of the next-generation biomarker test.

“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, in a statement.

Despite being a preventable disease, cervical cancer – which usually is a result from HPV – is one of the most common cancers in women around the globe.

CINtec PLUS Cytology will inform clinicians if women with high-risk HPV should undergo more follow-up for cervical cancer by detecting two biomarkers, p16 and Ki-67, which are associated with cervical cancer. If an HPV-positive woman has these, she is at an increased risk for developing the disease. Further, the test does not require extra sample collections, as it uses the same samples used for HPV or liquid-based Pap cytology tests.

The approval is based on the IMPACT trial, which included 35,000 women, and validated the screening tool. Publication of full findings are still pending.

With this approval, United States-based laboratories can use the Roche Cervical Cancer Portfolio, which includes the cobas HPV Test, CINtec PLUS Cytology and CINtec Histology.

“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,” Shinecker said.


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