RE: 60 million tests pm for professional use only?28 Apr 2021 21:57
It’s a rumour on Twitter. Nothing has changed. PresAl didn’t lead anyone to believe that Affidx is professional use only, it will be CE marked as professional use only. That’s it.
It’s up to individual govts how they choose to use/abuse any tests they procure with permission of their regulatory authority. In the U.K., they’ve developed their own IFU and ignored manufacturing CV results based on a sampling method and changed it to another. That’s has enabled them to use Innova tests and pop them in NHS boxes. They’ve similarly given permission for home use for professional use tests in Germany. There are probably other examples.
It’s not up to PresAl to dictate, speculate, rule in or rule out anything. He’s developed a professional use test and the market is easily large enough to sell on that basis. As it happens, the sampling method is very user friendly and the results are excellent. This suggests that CE marking for home use could be an option, but it will take some time. If there is no additional capacity and countries are giving permission for home use anyway, what’s the point in the time and expense of pursuing it? That time would be better spent with Mologic to ensure that all of the long term market lands at their door with a combined s/n test.