No one seems to draw a correlate the conditions th

No one seems to draw a correlate the conditions the FDA placed on its approval of Cue’s OTC test EUA with the apps Innova is integrating into its test. In approving the Cue EUA, the FDA required the consumer’s use of the test to be coordinated with a mobile device with apps that provided both step by step instructions on how to use the test and monitoring and reporting of the results. I realize the Cue test is not a lateral flow test, but I don’t see how whatever differences there may be between the Cue and Innova tests would motivate the FDA to dispense with requiring Innova to use similar apps to those used by Cue to provide similar instructing/monitoring functions for the Innova test. To me, I see these functions as part of the test and, without something performing these functions, the FDA will view the test as too inaccurate to approve. Other than theoretical arguments about whether the FDA is right, what am I missing? Why is it that the Cue EUA approval does not provide a roadmap for how Innova will get FDA approval? And if it does, how could a requirement that Innova’s OTC be accompanied by a monitoring and reporting app be bad for QTMM? Isn’t reporting/monitoring the value HealthID brings to the table?

I’m not talking about second generation tests that might incorporate quantum dots. If that happens, the utility and value is obvious. I’m talking about immediate value from integrating the HealthID app into the Innova test universe because the FDA might be requiring it as a condition to approval.