RE: Normal service resumed12 Oct 2021 15:06
I don’t know, but I’m not feeling confident it’ll be CE marked this month… it might be, that’s the best I can figure out lol.
This is what they’re doing at the moment… this is a kind of disclaimer from the circular.
“For example, the Genedrive® COV19 ID Kit has been tested to date using contrived samples and with minimal testing on clinical samples. There is a risk that the product does not perform on clinical samples in the same way as on contrived samples.
During the development process products may fail validation or not perform to the specifications intended, or not achieve the desired level of market penetration or sales. If the prevalence of the relevant disease reduces for any reason, it could have a material adverse effect on the financial prospects of the products and the Company.”