RE: FDA News Due Imminently3 May 2026 08:06
GENinCode PLC, a UK-based company specializing in cardiovascular disease (CVD) genetic testing, estimates its Total Addressable Market (TAM) at $10.5 billion.
GEN inCode
+3
Their focused Serviceable Available Market (SAM) is estimated at $4.5 billion.
GEN inCode
Key Market Data (as of mid-2025/early 2026)
Targeted Patient Pool: Initial market scoping indicates an addressable population of 21 million patients.
Key Prescription Potential: Approximately 8.5 million patients are expected to be prescribed the CARDIO inCode-Score test once comprehensive insurance coverage is secured.
Global Context: The broader global cardiogenomics market is projected to reach $3.57 billion by 2030.
Primary Growth Areas: The US, UK, and Europe, driven by increasing focus on preventative CVD care.
GEN inCode
+2
Product Portfolio Drivers
CARDIO inCode-Score: A polygenic risk score test for coronary heart disease, which recently secured New York State approval and is seeking FDA approval.
LiPID inCode: A diagnostic test for familial hypercholesterolemia (FH) used within the NHS.
ROCA Test: Risk assessment for ovarian cancer.
ADVFN UK
+1
As of early 2026, the company is focusing on commercial expansion in the US, Italy, and Germany to capture this market, with over 20 top-tier institutional sites already onboarded.