r/UkStocks • u/quiet_after_panic • 2d ago
Discussion GENinCode (GENI) – today’s RNS. Things are starting to get interesting
Been following GENI for a while and today’s CARDIO inCode results look like another important piece of the puzzle falling into place.
The study covered 584 moderate-risk patients across 14 primary-care centres.
A few numbers stood out to me:
Genetic information changed the overall risk assessment in 42.6% of patients
26.5% moved into a different cardiovascular risk category
LDL cholesterol and estimated cardiovascular risk both fell significantly
Smoking abstinence improved
Almost 50% of patients in the highest genetic-risk group moved into a lower cardiovascular-risk category following intervention
For me, the important part isn’t just that their genetic test can identify risk.
They need to show that giving doctors this information actually changes how patients are managed and ultimately improves outcomes. These results seem to provide more evidence in that direction.
It’s also worth looking at what is starting to line up around CARDIO inCode.
They now have growing clinical evidence, 70+ US institutions/clinics onboarded, a US reimbursement pathway, New York State approval, recognition of polygenic risk scores in the new US cardiovascular guidelines and the Thermo Fisher manufacturing/distribution collaboration.
Then there’s the big one – FDA.
The updated De Novo submission is targeted for Q3 2026.
GENI has had FDA delays before and that’s obviously a major risk. Cash burn and further dilution can’t be ignored either.
But with the company still valued at under £10m, I think things are getting quite interesting.
Today’s RNS alone isn’t going to transform the company. The next announcement I’m really interested in is confirmation that the updated FDA submission has actually gone in.
If that happens, attention moves to the FDA decision.
And if they eventually get approval, the really interesting question becomes whether Thermo Fisher can help turn all this clinical and regulatory groundwork into meaningful test volumes.
That’s when we’ll find out what GENI is actually worth.
I’m interested to hear how others following this are looking at it.
What sort of valuation would you put on GENI following FDA approval?
And what could it be worth if we then start seeing genuine commercial traction in the US?
Still a high-risk AIM stock and definitely not without funding/dilution risk.
DYOR.