I disagree with you. Firstly I have no idea about what you mean...

I disagree with you. Firstly I have no idea about what you mean 'positive', 80% accuracy or 90%? Secondly, commercialisation does not require FDA approval. The tool can be a supplementary diagnostic tool used to facilitate the formal diagnostic process. Although the sale price will be much lower (e.g. $1-2 per test instead of suggested $5-10) due to less certified, they can still generate revenue if with good marketing strategy. Of course, with FDA approval, the market scale and profit will be another story.