Availability of FDA-Approved Dual-Stain Triage Test Expands for Cervical Cancer Screenings

The first and only dual-stain triage test to be FDA approved, CINtec PLUS Cytology, will now be offered by BioReference Health LLC for patients with a high-risk human papillomavirus (HPV) result.¹

CINtec PLUS Cytology has a dual-stain biomarker technology to simultaneously detect p16 and Ki-67 in women with HPV-positive test results. Having both the p16 and Ki-67, biomarkers within the same cell is a strong indicator that an HPV infection is undergoing oncogenic transformation.^1,2

As a result, CINtec PLUS Cytology, a triage test for women who test positive for HPV, is now commercially available for ordering by healthcare providers.

"We know that cervical cancer is one of the most preventable forms of cancer," said Tamera Paczos, MD, MS, FACP, FACOG, vice president, associate chief medical officer, BioReference, in a press release. "We're pleased to enhance our cervical cancer screening test offerings with this innovative new test that provides valuable information that can be used to determine which patients with positive high-risk HPV and normal pap results may be at risk of harboring cervical pre-cancer."

HPV is the most common sexually transmitted infection and there are many types of HPV that can cause health problems, including cervical cancer, according to the Centers for Disease Control and Prevention. Patients who contract HPV may not develop cervical cancer until years or even decades later, or at all. As a result, the CINTec PLUS Cytology triage will work to determine a patient's individual risk level and assess if they would benefit from more immediate follow-up.

Previously in 2020, the FDA approved the expanded use of CINtec PLUS Cytology was the first triage test based on biomarker technology for patients who had a cervical cancer screening and whose results are positive for high-risk types of HPV.³

Then in 2021, CINtec PLUS Cytology dual-stain biomarker technology demonstrated a clear patient benefit in a trial of over 35,000 women between the ages of 25 and 65 years of age.² The IMPACT trial studied the CINtec PLUS Cytology and found that when compared with Pap, the CINtec PLUS Cytology was more sensitive in detecting cervical pre-cancers. The prevalence of atypical squamous cells of undetermined significance was detected in 6.5% with Pap vs 15.1% with the CINtec PLUS.

The test will be offered for use in women who are 30-65 years of age when their cytology result is NILM and the hrHPV result is positive with cobas HPV test.

Using this dual-stain biomarker test offers the treating healthcare providers more accuracy and allows them to quickly assess the risk for cervical pre-cancer in patients.

Experts treating patients with a high-risk HPV result use screening and triage tests depending on a patient's individual risk level to identify disease risk and create the best management strategies for patients. Testing strategies that result in greater disease detection can help healthcare providers care for their patients and lead to improved clinical outcomes.

With the CINtec PLUS Cytology, the number and frequency of follow-up visits may be reduced and the ability to provide patients with greater test result certainty will be increased.

"We're proud to be offering our patients more clarity and information that can empower them to better manage and understand their health," said Ellen Beausang, chief commercial officer, BioReference, in the press release "This test allows healthcare providers to act appropriately and in a timely manner, because they're equipped with more accurate test results that can better assess a patient's risk of cervical cancer related to HPV."

REFERENCES:

BioReference now offers the only FDA-approved dual-stain triage test to enhance cervical cancer screenings. News release. BioReference® Health LLC. February 9, 2023. Accessed February 10, 2023. https://prn.to/3YHGF8s

IMPACT trial data shows clear benefit in using Roche's CINtec PLUS Cytology test for women who are at higher risk of developing cervical cancer. News release. Roche. October 29, 2021, Accessed February 10, 2023. https://bit.ly/3nRHZVF.

Roche receives FDA approval for expanded use of the CINtec PLUS Cytology test to aid clinicians in preventing cervical cancer. News release. Roche. Published September 16, 2020. Accessed February 10, 2023. https://bit.ly/3JYtf46