RE:One new FDA approvalMy suspicion is that the FDA was caught off guard by the optics of poor accuracy for many of the tests that were approved early on. Now they need to spend addtional time to ensure test performance is understood and tests perform as advertised. I believe the statement of "Medmira is commited to gaining FDA approval" in the recent news suggests that they have been through some extra hoops that early approvals may not have needed.
But who knows.