Abbott receives FDA approval for HPV test to run on Alinity m

Nov. 20, 2023
Offering primary HPV screening and assessment of high-risk cancer-causing types of HPV.

Abbott has received U.S. Food and Drug Administration (FDA) approval for its molecular human papillomavirus or HPV screening solution, adding a cancer screening tool for detecting high-risk HPV infections to the Alinity m family of diagnostic assays.

The Alinity m high risk (HR) HPV assay is approved as a test for HPV detection and for use in routine cervical cancer screening as per professional medical guidelines. The assay is also approved for use in combination with a Pap test, for patients and physicians who prefer to use both tests, called co-testing. Importantly, the Alinity m HR HPV assay delivers information on five risk groups covering the 14 different potentially cancer-causing genotypes of the virus, helping physicians identify not just if a patient has an HPV infection but whether that infection is caused by one (or more) of the types that may cause cancer.

Abbott release