May 16, 2024—BD announced FDA approval of the BD Onclarity HPV assay for the use of self-collected vaginal specimens in a healthcare setting for HPV testing when cervical specimens cannot otherwise be obtained. The approval allows women to self-collect vaginal specimens in a health care setting, which could include nontraditional locations such as a retail pharmacy or mobile clinic.
“Many patients are uncomfortable with the intimate nature of a pelvic exam,” Dr. Jeff Andrews, vice president of global medical affairs for diagnostic solutions at BD, said in a company press release. “Also, many people live in areas without a local doctor or clinician trained to obtain a sample with a speculum. The option to self-collect in a clinical setting can help women overcome some of these barriers.”
The BD Onclarity HPV assay reports individual results for six of the 14 high-risk genotypes and grouped results for the remaining eight high-risk genotypes.