BD Begins Shipments of Self-Collection Tests for Cervical Cancer

BD has begun the first shipments of its human papillomavirus (HPV) self-collection kits to healthcare facilities in the US, which supports national and global initiatives to eradicate cervical cancer.
 
The BD Onclarity HPV Assay was recently approved by the FDA for HPV primary testing without the need for a traditional Pap smear, which is performed with stirrups and a speculum. 
 
The availability of self-collection provides a less invasive testing option, potentially improving access to testing for individuals who face barriers to cervical cancer screening, including for those in geographic areas where there is not a clinician trained to perform cervical examinations.
 
“I think women will be pleased to find that the steps for using the self-collection tests are easy to follow and that the test only requires a sample from the vaginal walls rather than the cervix,” said Dr. Jeff Andrews, board-certified gynecologist and vice president of Global Medical Affairs for Diagnostic Solutions at BD. “Patients and providers can feel confident that the accuracy of self-collected vaginal samples for HPV testing is similar to clinician-collected cervical samples. ”
 
The BD Onclarity HPV assay is the first and only HPV test that offers both extended genotyping and self-collection in a healthcare setting. This test reports six HPV strains individually, providing a more precise, accurate way to measure a woman’s risk for developing cervical precancer by showing results for an extended set of individual HPV strains and enabling those strains to be tracked over time. 
 
HPV causes virtually all cervical cancer, and HPV testing is the preferred screening method by the American Cancer Society in the United States. There are many strains (genotypes) of HPV viruses, with some strains posing a much higher risk for causing precancer and cancer than others. 
 
BD is working with the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), in a public-private partnership called the Cervical Cancer “Last Mile” Initiative to address disparities in cervical cancer screening. 
 
As part of this initiative, BD is participating in the Self-collection of HPV testing to Improve Cervical Cancer Prevention (SHIP) trial to evaluate the accuracy of Self-collection of HPV testing both in health care and other settings, including at home.