Becton Dickinson (BD) has obtained pre-market approval from the US Food and Drug Administration (FDA) for the BD Onclarity HPV assay designed to screen human papillomavirus (HPV) genotypes associated with high-risk cervical cancer.
The assay is designed to detect and identify 14 types of high-risk HPV from samples collected for the cervical cancer screening method, called Pap test, in the firm’s SurePath liquid-based cytology vial.
The test can also identify HPV 16, 18, and 45 genotypes known to be related to most cervical cancers, and disproportionally result in glandular cervical cancer in up to 94% of cases.
Becton Dickinson Diagnostics Systems president Dave Hickey said: “Our goal is to provide laboratories and clinicians worldwide with comprehensive cervical cancer screening solutions that address the unique needs of individual healthcare providers and patients.
“The addition of the BD Onclarity HPV assay to BD’s women’s health and cancer portfolio will enable BD to continue to enhance the standard of patient care, representing the next milestone in cervical cancer screening.”
The BD Onclarity HPV test obtained the European CE-IVD mark in 2014, followed by Canadian and Japanese regulatory approvals in 2017.
In the US, the assay is now clinically validated to be used as a primary screening test in combination with a Pap test, and to triage patients with abnormal Pap test results.
The FDA approval is based on the data from a multi-year, multi-centre, prospective clinical trial performed in more than 33,500 vaccinated and non-vaccinated women in the US.