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.
