A new self-swab test for human papillomavirus (HPV) is set to become available in doctors’ offices later this month, following its recent approval by the U.S. Food and Drug Administration (FDA). Developed by Becton, Dickinson and Company (BD), the BD Onclarity HPV Assay allows patients to collect samples themselves in a clinical setting, providing a less invasive alternative to traditional Pap smears.
The FDA granted approval for the BD Onclarity HPV Assay in May, marking a significant development in HPV screening. BD began shipping the self-swab kits to medical facilities on Thursday, with the kits expected to reach healthcare providers within the month. The introduction of this test is anticipated to improve access to HPV screening, particularly in underserved areas.
HPV is the most common sexually transmitted infection in the United States and is a major cause of cervical cancer, with approximately 36,000 new cancer cases attributed to HPV annually, according to the Centers for Disease Control and Prevention (CDC). Traditional HPV screening involves a Pap smear, where a small brush is used to collect cells from the cervix to detect abnormalities. However, many individuals find the pelvic exam involved in Pap smears uncomfortable due to personal, social, or religious reasons.
The BD Onclarity HPV Assay addresses these concerns by allowing patients to self-collect samples using a swab, which are then analyzed in a laboratory. Results are sent to the ordering physician, who communicates them to the patient. This approach aims to increase screening rates by offering a more comfortable and private option for patients.
Dr. Jeff Andrews, a board-certified gynecologist and vice president of global medical affairs at BD, emphasized the potential impact of self-collection on screening practices. “Self-collection changes the conversation about screening and is an important step forward toward the elimination of cervical cancer in our lifetimes,” he said.
In addition to BD’s offering, Roche Holding AG has also received FDA approval for a similar self-collection test, though no release date has been provided. BD has expressed plans to expand availability to at-home use by the end of the year, pending further FDA approval.
