GENinCode Files Pre-Submission for Cardio InCode-SCORE With US FDA
10 January 2022 - 10:02PM
Dow Jones News
By Kyle Morris
GENinCode PLC said Monday that it has filed its pre-submission
for Cardio inCode-SCORE with the U.S. Food and Drug
Administration.
The predictive genetics company said that it had been invited by
the FDA to file the pre-submission and this marks the start of the
regulatory pathway for U.S. market approval, anticipated later this
year.
Cardio inCode-SCORE is an in-vitro diagnostic test that assesses
the combined genetic and clinical risk of cardiovascular disease,
it said.
Shares in GENinCode at 1022 GMT trade up 0.5 pence, or 1.6%, at
32.5 pence.
Write to Kyle Morris at kyle.morris@dowjones.com
(END) Dow Jones Newswires
January 10, 2022 05:47 ET (10:47 GMT)
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