HPV Self-Screening Kits to Be Available in Coming Weeks Following FDA Approval
A test that will allow women to collect their own samples to screen for human papillomavirus (HPV) will be made available in the coming weeks, medical technology company Becton, Dickinson and Company (BD) announced Thursday.
HPV, the most common sexually transmitted infection (STI) in the United States, is typically screened for by a gynecologist via Pap smear — a procedure that causes discomfort for many women who would rather not place their feet in stirrups for a doctor to use a speculum to get a swab from their cervix.
With the “self-swab kits” from BD, which were approved for clinical use by the U.S. Food and Drug Administration (FDA) in May, patients will be able to swab themselves, ABC News reported.
BD told the outlet that it began sending out the kits, referred to as the BD Onclarity HPV Assay, on Thursday. They will start arriving at doctors’ offices and other healthcare practices for patient use.
BD’s kit is meant to be used by the patient in a private area in a clinical setting, “meaning in a private room inside a doctor’s office, in a mobile clinic, or in another health care setting,” where the patient can collect the cell sample herself before turning it in to the healthcare professional to be sent to a lab for testing. The “ordering doctor” will inform the patient of the results.
In a statement to the outlet, the company said it hopes to develop an HPV self-collection test available for at-home use by the end of 2024, pending federal approval.
While HPV can lead to potentially fatal diseases such as cervical cancer in women and penile cancer in men, Centers for Disease Control and Prevention (CDC) claims that 90 percent of cancers caused by HPV can be prevented with a vaccination.
“Over half of cervical cancers occur in women who have not been screened in the last five years or who have never been screened,” said Dr. Jeff Andrews, a gynecologist who serves as vice president of global medical affairs for diagnostic solutions at BD. “Self-collection changes the conversation about screening and is an important step forward toward the elimination of cervical cancer in our lifetimes.”
“It’s simple, private and easy to use, all of which can help those who, for a variety of reasons from socioeconomic to personal, haven’t been screened get access to potentially life-saving testing,” Andrews added.
Also in May, the FDA approved a similar HPV self-collection test from pharmaceutical company Roche Holding AG. Roche told ABC News it does not yet know when their test will be available to the public.
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