Getting Started with the FDA’s New LDT Rule
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
Curious about how laboratory-developed tests are regulated in other countries? We compare in-house test guidance across six regions
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
Though potential FDA LDTs regulation has drawn a lot of attention, other efforts could also have long-term effects on how labs do business.
The ALZpath DX assay is less invasive than other diagnostic tests, and may give patients diagnosed with Alzheimer’s more time to plan