RE: RNs out24 Feb 2026 21:14
The Company has recently announced it is working with its partner, Thermo Fisher Scentific, to support its revenue scale-up and expansion strategy for its lead product CARDIO inCode-Score across Europe, the UK, and the United States.
The Company developed the CARDIO inCode-Score genetic test (Polygenic Risk Score) following studies which identified genes and single nucleotide polymorphisms (SNPs) associated with the incidence of coronary heart disease (CHD). A genotyping test (CARDIO inCode-Score) was then developed to identify the SNPs for clinical validation and commercialisation. The genes, SNPs and algorithms used to calculate the polygenic risk score have received granted patent status in the US and EU.
The approval of CARDIO inCode-Score® test by the New York State Department of Health now completes the full state coverage under US Centers for Medicare and Medicaid Services (CMS) as well as the ability to collect patient samples from New York State physicians, clinics, and health institutions for testing at its Irvine, California lab facility which has also received a New York State clinical test permit.
In January 2025, the Company announced that its CARDIO inCode test had been included in the U.S. Centres for Medicare and Medicaid Services (CMS) 2025 Clinical Lab Fee Schedule with a median price of approximately $500 per test. This development is an important step in facilitating reimbursement from Medicare and Medicaid across the United States. In addition, the Company is preparing a MolDx submission for US state-based reimbursement following receipt of FDA approval.
LIPID inCode has an average reimbursement of $1,229, reflecting the Clinical Laboratory Fee Schedule for the test and the broad Familial Hypercholesterolemia Panel of tests to identify FH genetic variants.
In December 2025, GENinCode and Thermo Fisher Scientific signed a collaboration covering manufacturing, distribution and sales of CARDIO inCode-Score to laboratories across the US and Europe, Middle East and Africa (EMEA) regions. Prior to US FDA approval, laboratories will be introduced to CARDIO inCode-Score® as an 'In House Assay' for the prevention of heart disease. Following FDA Medical Device approval, the collaboration will extend to manufacturing and sale of the device to laboratories and test centres across the US. A similar approach will be adopted in the EMEA market.
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