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New Molecular Test Detects 14 High-Risk, Cancer-Causing HPV Genotypes

By LabMedica International staff writers
Posted on 06 Nov 2023
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Image: The FDA has approved the Alinity m high risk (HR) HPV assay to be run on Alinity m (Photo courtesy of Abbott)
Image: The FDA has approved the Alinity m high risk (HR) HPV assay to be run on Alinity m (Photo courtesy of Abbott)

HPV (human papillomavirus) infections are exceedingly widespread, with most individuals who are sexually active encountering this virus during their lifetime. There's a vast array of HPV strains, each characterized by its own genetic makeup. Certain types of HPV are known to lead to cancers, such as cervical cancer in women. While Pap tests were traditionally the standard method for cervical cancer screening, current professional recommendations favor HPV testing as the initial step for screening, which is recognized as a more effective approach. Despite this, some of the HPV tests currently in use lack approval for primary screening and offer limited insights into the specific HPV genotypes involved. Now, a new HPV test uses molecular technology to provide genotype determination on the 14 high-risk HPV types that are most likely to cause cancer.

The Alinity m HR HPV assay from Abbott (Abbott Park, IL, USA) is a new molecular HPV screening solution that provides a powerful cancer screening tool for detecting high-risk HPV infections. The U.S. Food and Drug Administration (FDA) has approved the Alinity m high risk (HR) HPV assay as a test for HPV detection and for use in routine cervical cancer screening in line with professional medical guidelines. For those who choose to employ both tests, this assay can be used in conjunction with a Pap test, a dual approach known as co-testing. What sets the Alinity m HR HPV assay apart is its ability to categorize infections into five risk levels across the 14 high-risk HPV genotypes. This provides clinicians with crucial information, not only confirming the presence of an HPV infection but also indicating whether it's linked to a genotype with a higher risk of developing cancer. The Alinity m HR HPV assay will be available for use with Abbott's Alinity m system, a cutting-edge molecular PCR instrument that offers quick and high-volume testing capabilities.

"HPV testing is a powerful tool for detecting HPV infections that can lead to certain cancers, including cervical cancer and illustrates the power of molecular diagnostics in infectious disease," said Keith Cienkus, vice president of Abbott's molecular business. "The Alinity m HR HPV assay was carefully designed to support patient care and streamline HPV testing."

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