Abbott Joins Crowded HPV Field With FDA Approval of High-Throughput Molecular Test
11-2-23 (by: Scott Gleason) Abbott has announced that the U.S. Food and Drug Administration has granted approval for its molecular human papillomavirus (HPV) screening solution. This diagnostic tool is now incorporated into the Alinity m family of diagnostic assays. Abbott joins a competitive market dominated by entrenched market players such as Hologic, Roche, and Becton Dickinson.
HPV, the most common sexually transmitted infection, poses a potential risk for cancer development, including cervical cancer in women. Traditionally, Pap tests were employed for cervical cancer screening. However, professional medical guidelines increasingly favor HPV testing for primary screening, as the superior method for cervical cancer detection. HPV tests look for certain high risk strains of the virus that can cause cervical cancer and when present women are reflexed for additional testing. American College of Gynecology guidelines recommend commencing cervical cancer screening for women at the age of 21, regardless of sexual activity initiationThe frequency and specific tests for cervical cancer screening vary based on age and individual health history. For women aged 21 to 29, a Pap test should be conducted every 3 years. While HPV testing alone can be considered for those aged 25 to 29, Pap tests are generally preferred in this age group. Women aged 30 to 65 have three different testing options available. They can choose to undergo both a Pap test and an HPV test (co-testing) every 5 years. Alternatively, they can opt for a Pap test alone every 3 years or HPV testing alone every 5 years.
Abbott’s Alinity m high-risk (HR) HPV assay is approved for HPV detection and routine cervical cancer screening as per medical guidelines. It is also sanctioned for co-testing with a Pap test, a preference for some patients and healthcare professionals. Notably, the Alinity m HR HPV assay provides information about five risk groups associated with the 14 potentially cancer-causing genotypes of HPV. The Abbott Alinity m HR HPV assay is available for use with the Alinity m laboratory instrument, Abbott’s advanced molecular polymerase chain reaction (PCR) platform that delivers rapid results at high volumes. The instrument can run 300 samples in 8 hours.
Dr. Mark H. Stoler, a professor (emeritus) of pathology and clinical gynecology at the University of Virginia, emphasized the importance of embracing primary HPV testing and extended genotyping. He stated, “As more women are vaccinated against the highest risk strains of the virus, it continues to be important to screen women for other HPV strains that have the potential to cause cancer. Extended genotyping enables us to improve risk assessment and tailor follow up for patients so we can minimize unnecessary treatment while still guarding against cancer development.”