Member Info for OAPK20

Tech- never mind. You won’t see it.

Tech is that a pic of the D man on @surprised_trade on X?

😆

MrOak- GENinCode apparently does not outsource the manufacturing of the CARDIO inCode test; instead, it conducts all aspects of the test’s development and processing in-house within its certified laboratories.

However specific details regarding the sourcing of any components or reagents used in the test are not publicly disclosed. So it’s unclear if they would be subject to Trumps Tariffs.

The company could clear this up in an RNS but the radio silence continues.

More costs, higher NI contributions, potential tariff implications and a risk of FDA saying no (leaked already ?) are killing the cash runway and shareprice.

Https://adanews.ada.org/ada-news/2025/april/exempt-medical-and-dental-supplies-from-tariffs-ada-urges/

1M yesterday and 500k today. The two LR’s printed today from yesterday (in the pumpers favourite words this time of year) maybe the old bed n isa!

🤪

Nobody sells 1.5m shares if there’s positive news about FDA approval. Looks time insiders already know

Tech re FDA - think it’s mainly due to CIC being an In Vitro Diagnostic (IVD) test which can be sold to multiple laboratories, hospitals, medical practitioners and clinics for use as opposed to an LDT (designed, developed, and used within a single CLIA-certified lab ie not mass-produced or widely distributed) So an LDT is only available through the specific lab that developed it. E.g Allelica PRS Test - Developed and run within a single CLIA lab.

IVD requires clinical validation, manufacturing controls, and regulatory submission to FDA before marketing. On approval it can be made available commercially to multiple labs and healthcare providers.

GENinCode chose the IVD route for CARDIO inCode-Score because they plan to distribute the test widely, not just use it in a single laboratory. This requires FDA approval through the De Novo pathway, which sets a regulatory precedent for similar genetic risk tests in the future.

Does that sound right to you?

Looks like De Novo has been a waste of time depending on any response by the Department of Health and Human Services (HHS) or subsequent legal developments.

Would the CARDIO inCode test continue to be regulated under CLIA without the need for additional FDA oversight as a medical device. Does the FDA even need to approve or make a decision ?

Either way the CEO needs to update GENI holders.

Tech - Texas - LDTs - benefits Allelica and the Mayo Clinic with their PRS for cardiovascular disease - more competition for CIC.

Makes you wonder why FDA are dragging their heels (if cheaper is already there) and why CEO remains silent.

Smells a bit

That you out Tech😜

2.4 if there’s nothing positive from the CEO. No new NHS contracts announced. No FDA update announced.

Rachael from accounts wrecking the cash runway, but they’re hiring.

Either there’s a significant increase in revenue or there’s another placing to keep the lights on.

Expected to facilitate the achievement of our production target over the coming months.

🧐

Assuming they get it. 60-80 chance

Still no decision. Tick tock. What else do they need.

“ The clinical-genetic test CARDIO inCode® Score assesses the propensity to develop Ischemic Heart Disease.

It has the most extensive, multi-ethnic, and studied case history in the world.”

So no news = Current SP = 1 - 1.1. = Old codgers and their numbers eh. GG hope you took any profit if you had it.

Pivot Point: 1.13p

Support Levels:

• S1: 1.10p

• S2: 1.02p

• S3: 0.98p

Familiar story here Tech…

Placees must be raging 😡

Hope the Trump/Musk mob rehired the person evaluating CIC score test after sacking them in February, otherwise April might become Q3.

CEO losing shareholder trust by not updating or replying to shareholders

Don’t tell us you bought at 4.5? Diamond hands though eh.

There’s a potential Unicorn deposit. It’s how much they’ll get for it and at what point do they sell

All those who banked their profits from 1p to 4p levels on the initial results rise.

GSCU used this to get the placing away. New comers be wary of the continual pumping on this just now.

The prospects are superb but they are just exploring for now. Raising, Drilling, Raising, Drilling.

It is nowhere near mining. More likely to be sold than developed by this minnow.

It discusses the cost-effectiveness of Cardio inCode®, a medical test, in assessing cardiovascular risk. It uses incremental cost-effectiveness ratio (ICER), which measures how much it costs to gain one additional quality-adjusted life year (QALY) compared to the standard method.

If Cardio inCode® costs €400, the additional cost per QALY gained compared to standard methods is:

• €12,969 in the REGICOR cohort (a cardiovascular risk prediction model).

Threshold Price for ICER Acceptance

• Spain generally considers an intervention cost-effective if ICER is below €30,000/QALY.

• For Cardio inCode® to stay within this limit, its price should be between €668 and €836.

• €21,385 in the Framingham cohort (another risk model).

• These ICER values indicate how cost-effective the test is at this price.

The test was most beneficial for patients with moderate to high cardiovascular risk.

• It reclassified risk in:

• 22.8% of patients in REGICOR.

• 12% of patients in Framingham.

• The ICER in this high-risk subgroup was:

• €1,652/QALY (REGICOR) → Very cost-effective.

• €5,884/QALY (Framingham) → Still cost-effective.

At €400, Cardio inCode® is cost-effective but close to the limit.

• For moderate–high-risk patients, it is highly cost-effective.

• If priced between €668–€836, it remains within Spain’s acceptable cost-effectiveness threshold