Is There a Regulating Pathway for Digital Diagnostics?

Gora: It's not easy to draw the boundaries between traditional diagnostics and, let's say, a new wav that we all feel coming of a generation of of more data driven diagnostics at their core. In some cases, traditional so called diagnostic, like a laboratory developed test, is regulated in a way that's very similar to other laboratory developed tests. Other digital diagnostics may be much more in the category of second order analytics that may help a patient or identify someone eligible for clinical trial. Gora: The regulatory dimension of this, as you know, is still evolving. As the f b a, considers a number of different dimensions that make these types of diagnostics unique