The lab in San Francisco asked in early February if it could develop its own lab test under less extreme requirements, but the FDA said that the lab would have to instead go through the more stringent emergency use authorization process, per regulation.
“We were trying to submit a clinical [lab-developed test] or develop a clinical [test] for [emergency-use authorization] approval, and the issue with it was it was delayed and that was because the FDA’s requirements were quite stringent,” Chiu said. “The FDA was making it too laborious…it would take too long to actually get approval.”
And at that point, with the more severe requirements in place, the lab felt that it would make more sense to wait for commercial labs to develop tests rather than creating their own.
“I think that it would have been helpful had some of the new guidance come out earlier so that laboratories would have had more time, whereas now we’re scrambling to meet demand,” Chiu said.