Laboratory-developed tests (LDTs) are diagnostic tests
developed and performed by local labs. They are widely used—thousands of
different LDTs are available—and include genetic tests, tests for rare
conditions, and companion diagnostics. LDTs are vital tools for personalized
medicine because labs can even create custom diagnostic tests.
Other diagnostic tests—in vitro diagnostic (IVD) test kits—are
regulated by the FDA as “devices.” Commonly, these are products containing all
or most of the components needed to perform a test, which are then packaged and
commercially distributed. The FDA is considering whether to regulate LDTs the
same way, which would mean each test would have an evidentiary mountain to
climb—difficult when tests are custom-designed for one particular patient!
Tell FDA that regulating LDTs as devices is a bad idea.
Dear [Decision Maker],
Sincerely,[Your Name] [Your Address] [City, State ZIP]