Licensing PRIOR to FDA22 May 2026 06:58
The really bullish part isn’t the FDA timeline — it’s that Thermo Fisher Scientific is already preparing to manufacture, distribute and scale CARDIO inCode-Score BEFORE FDA approval.
The key line was the LDT rollout to US labs prior to FDA clearance. That suggests commercial revenues and adoption could start building much sooner than many expect.
The New York State licensure and ~$500 reimbursement are also huge because they create an early US commercial pathway already in place.
Most importantly, Thermo wouldn’t partner up globally unless they saw serious potential. GENI now has access to Thermo’s massive installed base and distribution network across the US and EMEA, dramatically accelerating rollout potential.
Meaningful commercial traction could arrive well before it FDA
Let’s see two feet north of 1.20p today chaps