FDA Approves Expanded Use of CINtec PLUS Cytology Test in Preventing Cervical Cancer

September 16, 2020

The Food and Drug Administration approved the expanded use of the biomarker test CINtec PLUS Cytology that looks at HPV related biomarkers that could lead to cervical cancer. This is the first triage test approved in this space.

The Food and Drug Administration announced the approval of the expanded use of CINtec PLUS Cytology, the first triage test based on biomarkers for women who are found to be positive for high-risk types of human papillomavirus (HPV) in their cervical cancer screening results.

High-risk HPV is the chief cause of cervical cancer, and as the World Health Organization (WHO) has set goals for countries to take actions to eliminate cervical cancer within the next decade, testing for HPV risk is a priority.

CINtec PLUS Cytology is more sensitive than the traditional Pap (Papanicolaou) test that is used to screen women for potential signs of cervical cancer. The expanded approval for the test allows it to detect the simultaneous presence of the biomarkers p16 and Ki-67, an abnormality that is associated with HPV infections that are transforming and can lead to cancer if left untreated.

A positive result from the test signals that a woman has a significantly higher risk of the disease developing, whereas, women with negative dual strains have a significantly lower risk for cervical cancer, and can allow clinicians to let the body clear out the HPV infection. According to the test’s manufacturers, this could reduce the number of follow-up visits and allow labs to identify women that require follow up treatment quicker. Moreover, this allows labs to triage results from the traditional cobas HPV tests run during primary screenings for cervical cancer.

“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,” stated Thomas Schinecker, CEO Roche Diagnostics, in a press release.

“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 individualizing a woman’s care.”

Check back later for what you need to know about this approval.


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