One of the first tests that allows patients to self-collect samples to screen for human papillomavirus (HPV) will soon be available in doctors' offices.
In May, the U.S. Food and Drug Administration (FDA) approved a self-swab test from global medical technology company Becton, Dickinson and Company (BD) for "clinical" use, meaning in a private room inside a doctor's office, in a mobile clinic, or in another health care setting.
BD told ABC News that it started shipping its self-swab kits, called the BD Onclarity HPV Assay, to doctors' offices on Thursday and that kits will begin arriving at health care facilities later this month.
HPV is the most common sexually transmitted infection in the U.S. and can lead to several potentially deadly cancers, including cervical cancer, according to the Centers for Disease Control and Prevention. HPV causes some 36,000 cases of cancer in men and women in the U.S. every year, the CDC says.
Typically, screening for HPV in patients involves a Pap smear, also known as a Pap test. A small brush is used to gently remove cells from the surface of the cervix and the area around the cervix. The swab is then checked under a microscope for signs of cervical cancer or cell changes that could lead to cervical cancer.
In a press release, BD noted that many people are not comfortable with the pelvic exam required for a traditional Pap smear for a variety of reasons, including past negative experiences, or social or religious preferences. The company also noted that traditional exams may include people having to place their legs in medical stirrups, or doctors choosing to use speculums.
The new tests will allow patients to insert the swab and collect the sample themselves, even at a primary care doctor's office. The swabs are then sent to a lab, which will relay results to the ordering doctor, who will then update the patient.
By having a less-intrusive option, BD says more people, especially those living in medically underserved areas, can get screened for HPV and potentially prevent cervical cancer.
“Over half of cervical cancers occur in women who have not been screened in the last five years or who have never been screened," Dr. Jeff Andrews, a board-certified gynecologist and vice president of global medical affairs for diagnostic solutions at BD, told ABC News in a statement. "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.”
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 have an update regarding when their test will be available.
BD has said that it eventually wants to make its HPV self-screening test available for at-home use, adding that it could happen by the end of the year, pending FDA approval specifically for at-home collection.
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