By Michael Dabaie

 

Becton, Dickinson & Co. said it received approval for a pre-market approval supplement from the U.S. Food and Drug Administration for an expanded version of its BD Onclarity HPV Assay.

The PMA supplement includes the expansion for genotype reporting beyond human papillomavirus genotypes 16, 18, and 45 to include types 31, 51, 52, 33/58, 35/39/68, and 56/59/66 genotypes.

"With this FDA approval, BD can now offer laboratories, clinicians and patients access to critical information in screening for cervical cancer in the United States and other countries recognizing the PMA supplement or CE mark," Dave Hickey, president of Integrated Diagnostic Solutions at BD, said.

 

Write to Michael Dabaie at michael.dabaie@wsj.com

 

(END) Dow Jones Newswires

July 22, 2020 08:09 ET (12:09 GMT)

Copyright (c) 2020 Dow Jones & Company, Inc.
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