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.

For comments and feedback contact: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Amazon.com Inc.'s (AMZN) Chief Executive Jeff Bezos has told the company's employees said that the tech giant is not too big to fail, according to media reports. Shares of Nordstrom Inc. (JWN) slipped 10 percent in extended hours on Thursday after the department store chain's full-year revenue outlook fell short of Street estimates. Seattle-based Nordstrom's third-quarter profit dropped to $67 million or $0.39 per share from $114 million or $0.67 per share... Shares of Nvidia Corp. (NVDA) plunged 16% in extended session on Thursday after chip designer's third-quarter revenues and fourth quarter outlook fell short of Wall Street estimates. Santa Clara, California-based Nvidia's third-quarter profit surged to $1.23 billion or $1.97 per share from $838 million...
Follow RTT