Abbott Secures US FDA Approval For HPV Screening Solution

Abbott has acquired FDA approval for its molecular human papillomavirus (HPV) screening solution, bringing to the Alinity m family of diagnostic tests a strong cancer screening tool for detecting high-risk HPV infections. According to the US 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, as per pharmabiz.

Pap tests were historically used to screen for cervical cancer, but professional guidelines now urge testing for HPV infections, known as primary screening, over Pap tests as the best way to screen for cervical cancer. Some routinely used HPV tests however, are not recommended for primary screening and only provide limited information on which of the many distinct HPV genotypes are present. According to professional medical guidelines, the Alinity m high risk (HR) HPV assay is approved for HPV identification and routine cervical cancer screening. For patients and physicians who wish to employ both tests, the assay is also approved for use in conjunction with a Pap test, a procedure known as co-testing. Importantly, the Alinity m HR HPV assay provides information on five risk groups that cover the 14 different potentially cancer-causing genotypes of the virus, assisting physicians in determining not only whether a patient has an HPV infection but whether that infection is caused by one (or more) of the types that can cause cancer.