Abbott Gains FDA Nod for HPV Test on Alinity m

Abbott has received U.S. Food and Drug Administration (FDA) approval for its molecular HPV (human papillomavirus) screening solution, which adds a screening tool to spot high-risk HPV infections to the Alinity m family of diagnostic assays.
 
The Alinity m high-risk (HR) HPV assay is approved for HPV detection and use in routine cervical cancer screening. It’s also approved in conjunction with a Pap test for those who prefer to use both tests (co-testing). The assay delivers info on five risk groups covering 14 different potentially cancer-causing virus genotypes.
 
That way, according to Abbott, physicians can identify not just if a patient has an HPV infection but whether the infection is caused by one or more of the types that may cause cancer.
 
“Professional guidelines are clear in their recommendation to shift away from Pap tests in favor of clinically validated, primary HPV testing as the best way to detect risk of cervical precancer and cancer,” Mark H. Stoler, M.D., professor (emeritus) of pathology and clinical gynecology at the University of Virginia, told the press. “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.”
 
“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,” added 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.”
 
In addition to HPV, other assays available on the Alinity m system in the U.S. 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 (Epstein–Barr virus).