GENinCode PLC (AIM:GENI) shares moved up 32%, rising to trade at 2.84p, after the predictive genetics firm received approval from the New York State Department of Health for its CARDIO inCode-Score test.
The test is designed to predict genetic risk for coronary heart disease, and as a result of the approval.
Approval followed a process of analytical validation, clinical documentation and laboratory inspection. The test has an average reimbursement value of $500.
“Following careful evaluation by the New York State Department of Health, we are delighted to receive CARDIO inCode-Score® test approval to commercially promote CARDIO inCode-Score for genetic risk prediction of heart disease in the New York State,” said Matthew Walls, CEO of GENinCode.
"The approval also provides further support for our FDA De Novo assessment."
The company added that it continues to progress discussions with the FDA, and said it expects to submit additional data requested to complete its De Novo assessment in the first quarter of 2026.