Originally, we tried to bring the existing antibody tests that can only be sold to medical practitioners. During that process, we engaged in conversations with the FDA to get approval and we asked them what their concerns are with at-home antibody test kits. Once they explained us, we went back to the drawing board and worked on a solution that would allow us to mitigate the FDA’s concerns.

We then proceeded to present our solution to the FDA. They were positive so we filed for our pre-EUA and now we are working with an FDA reviewer.

I’m not going to pretend that our solution will end being approved. I have no idea since none of us (the three founders) have medical device experience. Nonetheless, we are willing to take a huge risk in terms of money and time, and at least know at the end that we gave it our best shot.