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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