FDA Breakthrough Device success rate is less than 10%
This product looks like yet another genetic DNA or RNA biomarker test, like all the others. They don't say, why not? Crap website, no published study data available. How much have the Spanish venture capitalists invested? Not enough for a new website! Why isn't this test already in use in the UK/Europe? It only has CE mark, not the new UKCA approval, why? How much does it cost?
Reminder, Colostat test for PROTEIN BIO MARKERS which are easily tested with ELISA machines found in just about every pathology lab on the planet.
"4.7. ELISA is the most commonly used protein-analysis method in clinical practice, especially in body fluids. New developments, such as electrochemical ELISA assays, increase the sensitivity of ELISA for protein biomarkers at low concentrations in body fluids by amplifying the signal. They are more cost-effective and easier to use"
