NEW YORK – Becton Dickinson said Tuesday that Health Canada has given an updated approval for the firm's human papillomavirus (HPV) test to allow testing with at-home self-collected samples.
The BD Onclarity HPV Assay is a qualitative PCR-based test for the detection of HPV and the extended genotyping of the virus, which is performed to aid the identification of 14 virus types, including those connected with high risk of cervical cancer and precursor lesions. The test has been approved and commercially available in Canada since 2017, and BD said that the test now can be used with self-collected vaginal specimens in addition to clinician-collected samples. The test is designed for use on Becton Dickinson's BD Cor and BD Viper instruments.
The firm noted that health authorities in Canada have found that HPV tests generally deliver results with the same accuracy whether they are performed with self-collected or clinician-collected samples, while self-collected sample collection also provides patients with a less invasive and less expensive alternative to a Pap test performed by a clinician.
"Self-collection is a game changer for health equity, as it removes the logistical, financial, and psychological barriers many women face when accessing traditional screening methods," BD Canada President Ivy Parks said in a statement.
Becton Dickinson's BD Onclarity HPV Assay was CE marked in 2014 and the firm received in 2021 a CE mark for use of the test with self-collected samples. The firm received in 2017 regulatory approvals for the test in Canada and Japan, and it received in 2018 US Food and Drug Administration premarket approval.