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BioReference Now Offers the Only FDA-Approved Dual-Stain Triage Test to Enhance Cervical Cancer Screenings


CINtec® PLUS Cytology offered as a reflex test when cytology is NILM and HPV positive

ELMWOOD PARK, N.J., Feb. 9, 2023 /PRNewswire/ -- BioReference® Health LLC, one of the largest full-service specialty laboratories in the United States, announced today it will be one of the first commercial laboratories to use offer the CINtec® PLUS Cytology test from Roche Diagnostics. CINtec PLUS Cytology is the only FDA-approved dual-stain triage test for patients who have a high-risk human papillomavirus (HPV) result. The test is commercially available for ordering by healthcare providers through BioReference, and its specialty division, GenPath® Women's Health.


Based on a patient's individual risk level, healthcare providers use screening and triage tests to identify disease risk and establish appropriate healthcare management. Testing strategies that result in greater disease detection can help healthcare providers care for their patients and lead to improved clinical outcomes. CINtec PLUS Cytology can reduce the number and frequency of follow-up visits, while providing patients clearer answers and greater test result certainty.

CINtec PLUS Cytology uses dual-stain biomarker technology to simultaneously detect p16 and Ki-67 in women with HPV-positive results. The presence of both biomarkers, p16 and Ki-67, within the same cell is a strong indicator that an HPV infection is undergoing oncogenic transformation. BioReference will offer the test to women aged 30-65 as a reflex when the cytology result is NILM and the hrHPV result is positive with cobas® HPV test. The dual-stain biomarker test allows a treating healthcare provider to more accurately and quickly assess the risk for cervical pre-cancer in patients.

"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. "This test allows healthcare providers to act appropriatey 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."

According to the Centers for Disease Control and Prevention (CDC), HPV is the most common sexually transmitted infection (STI). There are many different types of HPV and some types can cause health problems, including cervical cancer, which can take years or even decades to develop after a patient contracts HPV. However, not every HPV-positive woman will develop cervical cancer, and CINTec PLUS Cytology triage can determine a patient's individual risk level and if they would benefit from more immediate follow-up.

"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. "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."

About BioReference Health
BioReference® Health LLC, an OPKO Health, Inc. Company (NASDAQ: OPK), empowers confident healthcare decisions by prioritizing service, creating innovative solutions, and offering scientific expertise in oncology, urology, and women's health. Headquartered in Elmwood Park, New Jersey, BioReference operates 10 laboratory facilities around the country, is in-network with the largest health plans in the United States and processes more than 12 million tests, annually. BioReference provides credible and tailored solutions for a variety of customers and patients, including medical practices small and large, hospitals and health systems, correctional institutions, government agencies, educational systems, and sport leagues. In addition to an extensive test menu with 99 percent of tests performed in-house, BioReference's differentiated offerings include large-scale health screening programs, on-demand mobile phlebotomy, and transformative business solutions that optimize laboratory management. For more information visit or on Facebook, Twitter, Instagram and LinkedIn.


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Emily Smith

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SOURCE BioReference Health, LLC