The US Food and Drug Administration can help spur innovation, writes the agency's outgoing commissioner, Robert Califf, in an editorial at Wired. That's especially true, he adds, for next-generation sequencing-guided precision medicine.
In particular, he points to two agency initiatives, one to foster cooperation among sequencing researchers and another that details how the agency would approve such tests. The precisionFDA portal allows different developers to share data, software tools, and testing methodologies, which Califf says will accelerate technology development.
At the same time, he says the flexible roadmap the agency has developed for sequencing approval will reduce uncertainty regarding the process while also speeding it up. That roadmap consists of two guidance documents, one that recommends that developers use a set of industry-developed performance standards and one that says that developers could use data from community genomic databases to support their tests' clinical validity.
"Our goal is to help developers move efficiently from concept to commercially viable products by reducing uncertainty, encouraging best practices, and providing the regulatory flexibility that test developers need to innovate," Califf writes at Wired. "And we can do this while assuring patients and doctors that the tests they depend on are accurate, reliable, and clinically valid."
Califf is stepping down today.