New Self-Collection HPV Tests Approved, Could Help Boost Lagging US Testing Rates

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Women in the United States can now collect their own vaginal samples for human papillomavirus (HPV) testing.

The U.S. Food and Drug Administration approved two self-collection methods in health care settings, including non-traditional locations, such as retail pharmacies or mobile clinics.

The newly approved Onclarity HPV Assay and cobas HPV test assess for HPV without requiring a traditional Pap smear, allowing for less invasive testing options and possibly improving access to testing for women who face barriers or are not comfortable with traditional cervical cancer screening.

Unlike a Pap smear, which can only detect abnormalities in the cervix, the cobas HPV test can test for 14 types of high-risk HPV genotypes, according to a press release. Onclarity shows results for six individual HPV strains, rather than grouping them together. This provides a more precise assessment of a woman’s risk for cervical precancer, as per the company’s site.

Experts Hope for Improved Screening Adherence

More than 13,000 women are diagnosed with cervical cancer each year in the U.S., and 4,000 die from the disease annually, according to the National Cancer Institute.

HPV is the primary cause of nearly all cervical cancers, and HPV testing is the standard recommended screening method. The American Cancer Society encourages people aged 25 to 65 to get tested every five years.

Regular screening plays a crucial role in early detection and prevention of cervical cancer. Nearly half of cervical cancer diagnoses occur in patients who have never been screened, while seven in 10 of new cases involve women who have not been screened in the last five years, according to the U.S. Centers for Disease Control and Prevention.

“Despite the benefits of cervical cancer screening, not all women and people with a cervix get screened regularly,” Dr. William Dahut, chief scientific officer at the American Cancer Society, said in a press release. “We anticipate self-collection in a health-care setting will play an increasingly prominent role in cervical cancer screening once regulatory and clinical prerequisites are in place and as supporting evidence continues to accumulate,” he noted.