This whitepaper is a guide to better understand DTx, its regulatory landscape, and routes to commercialization. Explaining the challenges of conducting DTx clinical trials, solutions to these challenges, and the types of technology that will help them successfully build and manage trials.

DTx faces challenges on regulatory approval and commercialization paths. Regulatory bodies, payers, and physicians are starting to recognize the value of DTx and make adjustments, but lots of work remains.

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