
FDA Watch: A New Blood Test for Accurate Alzheimer’s Detection
The ALZpath DX assay is less invasive than other diagnostic tests, and may give patients diagnosed with Alzheimer’s more time to plan
The ALZpath DX assay is less invasive than other diagnostic tests, and may give patients diagnosed with Alzheimer’s more time to plan
Though things appeared status quo in 2023, last year may prove to be a turning point for the laboratory industry.
Comments on the FDA’s proposed rule to regulate LDTs as in vitro diagnostic devices reveal mixed reactions.
Debate is underway on whether current CLIA review of LDTs properly assesses a test’s likelihood to detect diseases.
Lab leaders say that the increased level of scrutiny proposed for such tests would be a detriment to innovation and patient care.