Abbott Obtains FDA Approval For HPV Test To Run On Alinity M

(RTTNews) - Abbott (ABT) said it has received U.S. Food and Drug Administration approval for its molecular human papillomavirus or HPV screening solution, adding a powerful 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.

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.

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