Yeah, without knowing the specifics of their study design or seeing the full results, it's impossible to make true comparisons to competitors. From what I can tell, they have been rather selective for sensitivity and specificity of Cognea's Canvas Dx and ETD's EarliPoint technology. If you look below, you'll see both technologies are actually quite good.
I've spent a little while looking into this and I don't like it. These diagnostic tools are not to replace the current standardised diagnoses by a professional, rather used as an adjunct, which Canvas Dx and EarliPoint both do a satisfactory job. Since both products are currently approved and Cognea apparently turning an income, there is too much competition for me. The only way that this looks promising is a direct, succesful comparison demonstrating significant superiority over Canvas Dx and EarliPoint, but this comes with substantial clinical risk.
Cognea are only making $9M per annum in sales.
EarliTec diagnostics demonstrating very good efficacy in a huge patient population.
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