https://techcrunch.com/2020/03/20/scanwell-aims-to-launch-at-home-15-minute-coronavirus-test-but-it-still-needs-fda-approval/

At-home diagnostics startup Scanwell, which produces smartphone-based testing for UTIs, is working on getting at-home testing for the novel coronavirus into the hands of U.S. residents. The technology, which was developed by Chinese diagnostic technology company INNOVITA and has already been approved by China’s equivalent of the FDA and used by “millions” in China, can be taken at home in 15 minutes with the guidance of a medical professional via telehealth, and produces results in just hours.

Scanwell’s test will require FDA clearance, but the company tells me that it’s in the process of securing approval through the FDA’s accelerated emergency certification program. The FDA guidance says that this approval process should take 6-8 weeks (though that “could be faster,” Scanwell says), and Scanwell is aiming to be ready to go with shipping these as soon as it receives that approval. While the U.S. drug regulatory agency previously had only included PCR tests in its protocols, it updated that guidance to include serological tests earlier this week. Scanwell further says they “don’t anticipate any issues with FDA approval.”