US approves self-tests for cervical cancer

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NEW YORK, May 16: The US Food and Drug Administration (FDA) has approved a new option for cervical cancer screening, allowing patients to self-collect vaginal samples in healthcare settings. Biotechnology company Roche and medical technology firm Becton, Dickson, and Company (BD) announced the FDA’s approval for the use of self-collected samples with their respective HPV tests.

Cervical cancer, primarily caused by human papillomavirus (HPV), can be detected through HPV screening, aiding in the identification of individuals at risk. Dr. Karen E. Knudsen, CEO of the American Cancer Society, highlighted the potential of self-collection to expand access to screening and improve patient outcomes.

Traditionally, gynecologists perform cervical screenings, involving cervical cytology or Pap tests, to detect precancerous or cancerous cells. However, some patients find these procedures uncomfortable or inaccessible due to a lack of trained providers.

Dr. Jeff Andrews, a gynecologist and vice president at BD, emphasized the importance of self-collection in overcoming barriers to screening. The BD Onclarity HPV Assay is now FDA-approved for HPV testing on self-collected samples, offering an alternative to traditional Pap tests.

Similarly, Roche’s cobas HPV test has been approved for use with self-collected samples. Collaborating with the National Cancer Institute, both companies are conducting trials to evaluate the accuracy of self-collection for HPV testing.

Each year, over 11,000 cases of cervical cancer are diagnosed in the United States, with about 4,000 resulting in death. Despite the benefits of screening, not all individuals undergo regular tests, leading to preventable cases.

Dr. William Dahut, chief scientific officer at the American Cancer Society, stressed the potential of self-collection in healthcare settings to increase screening rates and save lives. The FDA may further consider approving self-collection for home use, potentially revolutionizing cervical cancer screening methods.

Preventive measures such as HPV vaccination, smoking cessation, condom use, regular screening, and prompt follow-up for abnormal results remain crucial in preventing cervical cancer, according to the CDC.

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