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GeninCode Files FDA Pre-Submission for Cardiovascular Disease Risk Test

NEW YORK – UK-based GeninCode said Tuesday that it has filed a pre-submission for its Cardio inCode-Score cardiovascular disease risk test with the US Food and Drug Administration. 

The in vitro diagnostic test is designed to assess an individual's genetic and clinical risk to predict and prevent CVD. 

Pre-submission is the first step on the test's path toward US regulatory approval, which the company anticipates obtaining later this year.

GeninCode signed an agreement last year with Milwaukee-based Eversana to commercialize GeninCode's products in the US.

Other GeninCode products include Lipid inCode for familial hypercholesterolemia, and Sudd inCode for sudden cardiac death. 

"Despite the delays driven by the pandemic, the filing of the Cardio inCode FDA pre-submission marks the start of the US regulatory approval pathway and ongoing preparation for the launch of Cardio inCode-Score later this year," Matthew Walls, CEO of GeninCode, said in a statement. "We are well placed to improve the CVD standard of care by identifying individuals at high genetic risk who can be advised on lifestyle choices and access to personalised treatment to improve future health outcomes."