Abbott's Alinity M High-Risk HPV Molecular Assay Receives FDA Approval

On November 2, Abbott announced that its human papillomavirus molecular test has received regulatory approval from the U.S. Food and Drug Administration.

Abbott said in a statement that the Alinity M High-Risk Human Papillomavirus (HPV) test provides information on five risk groups covering 14 carcinogenic genotypes to determine whether a patient is infected with HPV and the type of infection. It has been approved as a reagent for detecting HPV, used in routine cervical cancer screening, and can also be used in conjunction with the Pap test.

Keith Cienkus, vice president of Abbott's molecular business, said in a statement: "The assay, which runs on Abbott's Alinity M PCR-based platform, is thoughtfully designed to support patient care and streamline HPV testing."

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