Shares in GENinCode PLC surged on Tuesday after the company said it received state licensing approval as well as the Clinical Laboratory Improvement Amendments certification for its Irvine laboratory in California.

Shares in the Oxford, England-based biotechnology company focused on the prevention of cardiovascular disease jumped 74% to 12.92 pence on Tuesday morning in London.

GENinCode said the approval from the Centres for Medicare and Medicaid Services enables the provision of its products for the risk assessment of cardiovascular disease to patients across 49 states in the US.

The company added that it ‘marks a major milestone’ in the commercialisation of its polygenic cardiovascular disease products, Cardio inCode and Lipid inCode, which can now to be sold across the US and serviced from GENinCode’s California lab.

According to GENinCode, Cardio inCode measures an individuals’ inherited genetic risk of coronary heart disease, and Lipid inCode measures an individuals’ inherited genetic inability to metabolise LDL-C cholesterol, giving rise to accelerated onset of heart disease.

‘The approval of the California state licence and CLIA certification enables us to begin to sell our products across the US market. There has been a tremendous work effort to deliver these approvals, representing a major advance in the company’s commercial programme,’ Chief Executive Matthew Walls said.

‘We continue to work closely with our US partner collaborators on launch planning and advancing our Early Access Programs in preparation for commencement of US revenue in 2023.’

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