The need for new test verification and regulatory support for innovative diagnostics

The RADx program has paved a path forward for small- and medium-sized diagnostics companies with innovative ideas and novel technologies to help meet public health challenges and compete in the marketplace. A funded network of agile academic or private laboratories that can objectively evaluate novel clinical tests, whether they originate from the largest diagnostics companies or new startups, can provide impartial and cost-effective third-party assessments of test performance to facilitate FDA decision making. Source: Nature Biotechnology.