Check out slides 7 referring to their lab partnerships and slides 21 and 22 that shows the people involved.
Looks like they have partnerships already with a few Sonic Healthcare labs in Germany and ex-Roche Diagnostics people are all over this.
Given that they use the Roche Light Cycler as the reader and the fact that Freenome (Roche backed) doesn't have anywhere near the same sensitivity for AA detection, I wouldn't be surprised to see Roche back this financially to support their proposed 15,000 patient US pivotal study to support US FDA approval.
Their latest study had 21 recruitment sites including both EU and US patient data.
Their main challenge looks like they're going need to raise US$20M+ to fund the pivotal study in the US and their current market cap is only US$17M - that's a big ask. This said their clinical performance data released late last week may prove to be the catalyst they require to get such a big capital raise completed.
Mainz-Biomed_Corporate-Presentation_Apr-2024-v4.25.pdf (mainzbiomed.com)
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