Abbott receives FDA approval to run HPV test on Alinity m, providing primary HPV screening and assessment of high-risk cancer-causing HPV types

• Most sexually active adults are infected with HPV, according to CDC; new test detects HPV genotypes that may cause cancer
• Abbott’s new HPV test uses molecular technology to genotype 14 high-risk, cancer-causing HPV types
• This test is one of the few^Yo HPV test approved for primary screening for cervical cancer based on recommendations from professional guidelines

Abbott ParkSick., November 2, 2023 /PRNewswire/ — Abbott’s (NYSE: ABT) molecular human papillomavirus, or HPV, screening solution has received U.S. Food and Drug Administration (FDA) approval, adding utility to the Alinity m Series A powerful cancer screening tool diagnostic assay for detecting high-risk HPV infection.

According to the Centers for Disease Control (CDC), HPV infections are extremely common—most sexually active adults will experience an HPV infection at some point in their lives. There are many different strains of HPV, each with unique genetic characteristics, or genotypes. Certain genotypes of HPV can cause cancer, including cervical cancer in women.Historically, the Pap test was used to screen for cervical cancer, but now there are professional guidelines^two,

Testing for HPV infection (called primary screening), rather than a Pap smear, is recommended as the best way to screen for cervical cancer. However, some commonly used HPV tests are not approved for primary screening and provide only limited information about the presence of many different HPV genotypes.

The Alinity m High Risk (HR) HPV Assay is approved as a test for HPV detection and for routine cervical cancer screening in accordance with professional medical guidelines. The test is also approved for use in conjunction with a Pap test for patients and doctors who prefer to use both tests, called a combination test. Importantly, the Alinity m HR HPV test provides information on five risk groups covering 14 different potentially cancer-causing virus genotypes, helping doctors determine not only whether a patient has an HPV infection, but also whether that infection is caused by one (or Various) causes) types that may lead to cancer.

“Professional guidance clearly recommends abandoning the Pap smear test in favor of clinically validated primary HPV testing as the best way to detect cervical precancerous lesions and cancer risk,” he said. Mark StollerMD, Professor of Pathology and Clinical Gynecology (Emeritus) University of Virginia. “As more women are vaccinated against the highest risk strains, it remains important to screen women for other potentially cancer-causing HPV strains. Expanded genotyping allows us to improve risk assessment and tailor it to patients Tailor follow-up so we can minimize unnecessary treatments while still preventing cancer progression.”

“HPV testing is a powerful tool for detecting HPV infection, which can cause certain cancers, including cervical cancer, and illustrates the power of molecular diagnostics in infectious diseases,” he said. Keith SienkusVice President, Abbott Molecular Business. “The Alinity m HR HPV test is designed to support patient care and simplify HPV testing.”

The Abbott Alinity m HR HPV Test is available on Abbott’s Alinity m laboratory instruments, Abbott’s most advanced molecular PCR platform that delivers fast, high-volume results. In the United States, tests available on the Alinity m system include: SARS-CoV-2 (Emergency Use Authorization), Resp-4-Plex (Emergency Use Authorization), HCV (Hepatitis C), HBV (Hepatitis B), HIV-1 (human immunodeficiency virus type 1), STI (CT/NG/TV/MG), CMV (cytomegalovirus) and EBV (EBV).

About Arinti:
Abbott’s Alinity family of coordinated solutions is unprecedented in the diagnostics industry, and together they address the challenges of using multiple diagnostic platforms and simplifying diagnostic testing. Alinity systems are designed for efficiency, with the goal of running more tests in a smaller space, generating test results faster and minimizing human error, while continuing to deliver high-quality results. Availability of Alinity systems and testing varies by geographic location.For more information please visit alinity.com.

About Abbott:
Abbott is a global healthcare leader committed to helping people live more fully at every stage of life. Our portfolio of life-changing technologies spans healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals. Our 115,000 colleagues serve people in more than 160 countries.

contact us: www.abbott.comon LinkedIn www.linkedin.com/company/abbott-/,on Facebook www.facebook.com/Abbott And on Twitter @AbbottNews.

^Yo U.S. Food and Drug Administration. See www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm
^two, The American College of Obstetricians and Gynecologists (ACOG), the Society of Gynecological Oncology (SGO), and the American Society for Colposcopy and Cervical Pathology (ASCCP) all endorse the United States Preventive Services Task Force (USPSTF) cervical cancer screening recommendations.See ACOG’s reiterated updated cervical cancer screening guidelines April 2023. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2021/04/updated-cervical-cancer-screening-guidelines

SOURCE Abbott