Becton Dickinson Gets FDA Approval for HPV Test with Extended Genotyping Capabilities
July 22 2020 - 08:24AM
Dow Jones News
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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