FDA approves Abbott HPV test to run on Alinity m

Nov. 3, 2023—Abbott has received FDA approval for its molecular human papillomavirus screening test to run on the company’s Alinity m system. The Alinity m High Risk (HR) HPV assay is a qualitative in vitro test for the detection of DNA from 14 high-risk HPV genotypes in clinical specimens. The assay specifically identifies HPV genotypes 16, 18, and 45 while reporting the concurrent detection of the other high-risk genotypes (31/33/52/58 and 35/39/51/56/59/66/68) at clinically relevant infection levels. It is for use in routine cervical cancer screening, as per professional medical guidelines, and is approved for use in combination with a Pap test.