GENinCode PLC (AIM: GENI) jumped 32% to 2.84p in early trading after securing approval from the New York State Department of Health (NYSDOH) for its CARDIO inCode-Score test, which assesses genetic risk for coronary heart disease.
The approval followed analytical validation, clinical documentation and a laboratory inspection. The test carries an average reimbursement value of about $500.
“We are delighted to receive CARDIO inCode-Score approval to commercially promote the test for genetic risk prediction of heart disease in New York State,” said CEO Matthew Walls, adding that the clearance also strengthens the company’s FDA De Novo submission.
GENinCode said it continues to work with the FDA and expects to provide the remaining data required to complete the De Novo assessment in the first quarter of 2026.
Matthew Walls, GENinCode Chief Executive Officer said: “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. The approval also provides further support for our FDA De Novo assessment.”
For more information visit www.genincode.com
Enquiries:
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GENinCode Plc |
www.genincode.com or via Walbrook PR |
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Matthew Walls, CEO |
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