After collecting an FDA greenlight earlier this year, BD is launching a real-world study to see if its self-collection kits for HPV testing will improve cervical cancer screening rates among underserved communities in southern Texas.
Through a collaboration with MD Anderson Cancer Center and Su Clinica, a federally qualified health center, the company described the pilot program as the first of its kind, spanning locations in Brownsville, Harlingen, Raymondville and Santa Rosa.
“Not only can cervical cancer be prevented, with greater access to vaccines and screening, we have a real opportunity to eliminate this disease as a public health problem in our lifetimes,” Su Clinica CEO Elena Marin said in a statement.
“Women in our region are disproportionately affected by cervical cancer, both in terms of rates and mortality, so there is an urgent need to remove barriers to potentially life-saving screening, and self-collection is a pivotal solution,” Marin added. “Having a test that is safe, private, and easy to use will go a long way towards increasing cancer screening rates for those who may be hesitant or unable to receive a traditional screening.”
BD’s Onclarity HPV assay received an FDA approval in May, alongside a test developed by Roche, that allows women to skip the traditional Pap smear exam. The test is still administered within a clinic, not at home, but it enables the user to obtain the sample themselves. HPV, or human papillomavirus, causes nearly all cases of cervical cancer.
The study—supported by a five-year, $2.5 million state grant from the Cancer Prevention and Research Institute of Texas, or CPRIT—will be used to identify any specific challenges to using the test, such as lack of insurance, limited health care resources, and cultural or language barriers.
To start, the program will provide bilingual self-collection options and financial support for uninsured patients. Its findings will help develop best practices for scaling up the test to other underserved areas nationwide, according to BD.