Abbott Molecular HPV Test Nabs FDA Approval

Original from: 360dx

Abbott announced on Thursday that its molecular test for human papillomavirus has received regulatory approval from the US Food and Drug Administration. 

The Alinity M High Risk HPV Assay provides information on five risk groups covering the 14 cancer-causing genotypes of the virus to determine if a patient has an HPV infection and what type, Abbott said in a statement. It is approved as a test for HPV detection and for use in routine cervical cancer screening, as well as in combination with a Pap test. 

The assay runs on Abbott's Alinity M PCR-based platform and "was carefully designed to support patient care and streamline HPV testing," Keith Cienkus, VP of Abbott's molecular business, said in a statement. 

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Source: Abbott Molecular HPV Test Nabs FDA Approval