Genedrive (LON: GDR) shares are up 18%. GDR shares are up on the announcement that they’ve achieved UKCA on one of their tests. This just isn’t worth that much. Sure, the UKCA is required to be able to market it in the UK. But that’s all it is, a piece of paperwork. It’s not - absolutely not - akin to or anything like FDA approval. It’s not, actually, something external to Genedrive even. It’s far more like deciding upon the colour of the packaging box than it is a verification that the test works and people want to buy it.
We discussed this earlier about Genedrive: “Think back a bit to when the world was all so very interested in covid tests. Genedrive announced that it had applied for, then received a CE Mark for its test. This set the share price off on a significant romp, hundreds of percents of price rises over time. This of course all faded back as well. Because a CE Mark isn't a thing of any great importance. Or rather it is but it isn't. Yes, it's necessary to have a CE Mark to sell something into the European Union market. But it's not difficult to gain a CE Mark. It's just a matter of filling out the paperwork properly and then paying the fee. It is not - absolutely not - anything like an FDA approval which is the product of rigorous testing. But we all got the impression that a CE Mark was important - which is why the share price rise back then. And the fall back as the realisation sank in. Now, it is possible to think that that's just good management. Boost the share price with a bit of decent PR. It's also possible to think that if management is led to, err, guide investor sentiment in that manner then what else are they guiding in that manner?”
Genedrive share price from Google Finance.
Note those grand peaks in the GDR share price around the time of the CE Mark rumpus. Not how they didn’t stick at that nice high price?
Now we get this announcement: “genedrive plc (AIM: GDR), the point of care molecular diagnostics company, announces it has achieved UKCA marking registration for its new Genedrive® CYP2C19 System. It is a point of care pharmacogenomic test that can differentiate between patients that could respond to clopidogrel treatment and those that will not, allowing more effective drug treatment to be prescribed on a personalised basis. The test can be performed at the bedside or in a ward, and can deliver a clinically actionable result in about one hour.” OK and how lovely and all of that.
But the UKCA is the replacement, post-Brexit, for the CE Mark. It’s a piece of paper the company fills out then they pay the fee and, well, they’ve a UKCA. It doesn’t tell us anything - at all - about whether the test works, anyone wants to buy it or anything else. It’s simply a piece of bureaucratic paper work and that’s it.
A UKCA simply isn’t worth 18% on a share price, not even at Genedrive.
