Abbott’s HPV Test Gets FDA Approval for High-Risk HPV Detection and Cervical Cancer Screening

Abbott’s HPV Test Gets FDA Approval for High-Risk HPV Detection and Cervical Cancer Screening

Professional guidelines now recommend the use of molecular testing over Pap tests for primary cervical cancer screening, but very few tests in the market are approved for primary screening.

Abbott’s molecular human papillomavirus (HPV) screening solution has received approval from the US Food and Drug Administration (FDA) for detecting high-risk HPV infections and as a primary cervical cancer screening tool. The HPV test is an addition to Abbott’s Alinity m diagnostic assay family.

The Alinity m high risk (HR) HPV assay is approved for HPV detection and use in routine cervical cancer screening as per professional medical guidelines, explained Abbott in a press release announcing the FDA approval.

The HPV test is designed to detect 14 different high-risk cancer-causing types of the virus, which are categorized in five risk groups. This will help physicians identify whether an individual has an HPV infection and importantly, whether that infection is caused by one (or more) of the types that may cause cancer, said Abbott.

Of the high-risk HPV types, HPV 16 and HPV 18 are responsible for most HPV-related cancers, according to the National Cancer Institute (NCI). These HPV types increase the risk of cervical, vaginal and vulvar cancer in women, penile cancer in men and anal and head and neck cancers in both women and men (the latter particularly associated with HPV 16).

Abbott’s HPV test is also approved for co-testing in combination with a Pap test, which is an option available to patients and physicians who might want to use both tests.

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Pap tests, or Pap smears, have been the convention to screen for cervical cancer but professional guidelines now recommend testing for HPV infections as the best way to screen for the cancer. While there are commonly used HPV tests in the market, not all are approved for primary screening and only provide limited information about the different genotypes of HPV present. Molecular testing for HPV types that are known to cause cervical cancer is certainly welcome as Pap tests are invasive and can be uncomfortable.

According to the US Centers for Disease Control (CDC), most sexually active adults will experience an HPV infection at some point in their lives.

Abbott said that Alinity m HR HPV assay will be available for use on the company’s Alinity m laboratory instrument, Abbott’s most advanced molecular PCR platform which provides fast results in high volumes.

Related: New HPV Vaccine Data Shows Long-Term Impact – Featuring Dr. Elmar Joura from the Medical University of Vienna – Xtalks Life Science Podcast Ep. 130

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Some current assays that are used with the Alinity m system in the US include SARS-CoV-2 (emergency use authorization), Resp-4-Plex (emergency use authorization), HCV (Hepatitis C), HBV (Hepatitis B), HIV-1 (human immunodeficiency virus type 1), STI (CT/NG/TV/MG), CMV (cytomegalovirus) and EBV (epstein–barr virus).

“HPV testing is a powerful tool for detecting HPV infections that can lead to certain cancers, including cervical cancer and illustrates the power of molecular diagnostics in infectious disease,” said Keith Cienkus, vice president of Abbott’s molecular business. “The Alinity m HR HPV assay was carefully designed to support patient care and streamline HPV testing.”

According to the CDC, every year in the US, about 11,500 new cases of cervical cancer are diagnosed and about 4,000 women die of the cancer.