Abbott receives FDA approval for HPV test to screen and assess high-risk disease

November 2, 2023- Abbott has received U.S. Food and Drug Administration (FDA) 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.

According to the U.S. Centers for Disease Control (CDC), HPV infection is extremely common – most sexually active adults will experience an HPV infection at some point in their lives.

There are many different strains of HPV, each with a unique genetic signature or genotype. Specific genotypes of HPV can cause cancer, including cervical cancer in women. Historically, Pap tests were used to screen for cervical cancer, but today professional guidelines recommend testing for HPV infections, called primary screening, over Pap testing as the best way to screen for cervical cancer.

However, some commonly used HPV tests are not approved for primary screening and only deliver limited information regarding which of the many different genotypes of HPV are present.

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