logo
Plus   Neg
Share
Email

BD Gets Pre-market Approval From FDA For BD Onclarity HPV Assay

Becton, Dickinson and Co. (BDX) or BD said that it has received pre-market approval from the U.S. Food and Drug Administration for the BD Onclarity HPV assay.

The test detects 14 types of high-risk human papillomavirus (HPV) from specimens collected for cervical cancer screening or "Pap test" in the BD SurePath liquid based cytology vial.

The BD Onclarity HPV assay also identifies HPV genotypes 16, 18, and 45, which are associated with the majority of cervical cancers worldwide, and are disproportionally responsible for up to 94 percent of glandular cervical cancer cases.

BD plans to seek approval in future submissions for reporting of HPV types beyond 16, 18 and 45 consistent with the extended genotyping capabilities of the assay's design and aligned with evolving cervical cancer screening guidelines.

by RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Shortly after announcing a racial bias training for the staff, Starbucks revealed its changed policy of allowing anyone to use its spaces, rest rooms, cafes and patios even without buying anything from the stores. The new policy will be consistent all across U.S. stores. Tesla Inc.'s CEO Elon Musk has revealed new specifications and options for its Model 3 electric car, including a high-end version of the sedan that will cost around $78,000. In a series of posts on Twitter Saturday night, Musk said that the Model 3 will be available in two versions, with dual motors and all-wheel drive in July. Musk also made an announcement regarding a new service program. Billionaire entrepreneur Elon Musk on Thursday showed off his concept for the Loop, a high-speed underground public transportation system that will carry up to 16 people and travel at 150 miles per hour. At the Boring Company Information Session, Musk and project leader Steve Davis provided details of the underground mass transit tunnels that the Boring Co. plans to build beneath Los Angeles.
Follow RTT