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HPV Self-Screening Kits to Be Available in Coming Weeks Following FDA Approval

Medical technology company Becton, Dickinson & Company (BD) announced Thursday that a test that allows women to collect their own samples to be tested for human papillomavirus (HPV) will be available in the coming weeks.

HPV, the most common sexually transmitted infection (STI) in the United States, is usually tested for by a gynecologist with a Pap smear — an uncomfortable test for many women who don't like having to stand in stirrups while a doctor uses a speculum to take a swab from their cervix.

BD's “self-swab kit,” which was approved for clinical use by the U.S. Food and Drug Administration (FDA) in May, will allow patients to administer their own swab tests, ABC News reports. Reported.

BD told the outlet that it began shipping its BD Onclarity HPV test kits on Thursday, and that the kits will begin arriving at clinics and other healthcare facilities for patient use.

BD's kits are intended for use by patients in private areas of a clinical setting — “a private room in a clinic, a mobile clinic, or other healthcare settings” — where patients can collect their own cell samples and submit them to a medical professional to be sent to a lab for testing. The “referring physician” will then notify the patient of the results.

In a statement to the media, the company said it hopes to develop an at-home self-sample HPV test by the end of 2024, pending federal approval.

HPV can cause deadly diseases, including cervical cancer in women and penile cancer in men, but the U.S. Centers for Disease Control and Prevention (CDC) Claims 90 percent of cancers caused by HPV can be prevented by vaccination.

“More than half of cervical cancer cases occur in women who have not been tested in the past five years or have never been tested,” said gynecologist Dr. Jeff Andrews, global medical vice president, Diagnostic Solutions, at BD. “Self-sampling is a critical step towards changing the conversation around testing and eliminating cervical cancer in our lifetimes.”

“The test is simple, private and easy to use – all of this will help ensure that people who might not be able to get tested for a range of reasons, from socio-economic to personal, can get a potentially life-saving test,” Mr Andrews added.

Also in May, the FDA approved a similar self-sample HPV test from drug company Roche Holding AG. Roche told ABC News it doesn't yet know when the test will be available to the public.

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