New self-collection HPV tests approved by the FDA could enhance cervical cancer screening accessibility and adherence.
By yourNEWS Media Newsroom
Women in the United States can now collect their own vaginal samples for human papillomavirus (HPV) testing, following the U.S. Food and Drug Administration’s (FDA) approval of two new self-collection methods.
The FDA approved the Onclarity HPV Assay and cobas HPV test, which can be used in healthcare settings, including non-traditional locations such as retail pharmacies or mobile clinics. These tests provide a less invasive option compared to traditional Pap smears, potentially improving access to testing for women who face barriers or discomfort with conventional cervical cancer screening.
Unlike a Pap smear, which can only detect abnormalities in the cervix, the cobas HPV test screens for 14 types of high-risk HPV genotypes, according to a press release. The Onclarity test provides results for six individual HPV strains, offering 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 advises individuals aged 25 to 65 to get tested every five years.
Regular screening is crucial for early detection and prevention of cervical cancer. Nearly half of cervical cancer diagnoses occur in patients who have never been screened, while seven in ten 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.
The approval of these self-collection tests is expected to help overcome some of the barriers to regular cervical cancer screening, thereby reducing the incidence and mortality associated with the disease.