The FDA's response for decades is this: you don't have a lab to perform a more detailed confirmation (because false positives sometimes do happen), and you have no doctor or counselor to be there with you when you get the results.

I worked for a biotech firm that had an instant HIV test available a long long time ago. It was deemed too irresponsible to let people to check themselves at home because the company (and the FDA, and everyone's lawyers) were afraid of people doing rash things after a positive result. If a false-positive HIV patient killed themselves and the family sues, that would be...bad.

Even today, the home-HIV test that's on the market involves you sending in the sample and then getting a phone call with the results.

So as a researcher he provides data which the FDA will use to assess accuracy and viability, meanwhile Columbia will probably lease out the patents (https://patentimages.storage.googleapis.com/pdfs/US200600033...) when it issues to a diagnostics company, perhaps to Elizabeth Holmes company (http://www.wired.com/2014/02/elizabeth-holmes-theranos/) who will then create a cost effective way to put this into drug stores everywhere, and when you're feeling bad you go in, prick your thumb, and get a text message of everything you might be sick with.

2. No software company wants to deal with the liability issues

An example of a place where technology takes over a large part of the diagnostic process is prescription glasses. Even then, after measuring your absolute dioptres, a human asks you to try a few combinations to find the most comfortable variant.