LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
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FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
MeMed Sepsis Test Gains Breakthrough Device Designation
The 15-minute assay to detect sepsis and assess its severity and risk is expected to get full FDA approval by 2026
FDA Watch: How Could the End of Chevron Impact the FDA and LDTs?
A lawsuit by a group of herring fishermen upended 40 years of legal precedent regarding how federal agencies interpret statutes
Special Analysis: Addressing Key Concerns Around the FDA’s Final LDTs Rule
Experts answer key questions related to laboratory-developed test regulation during G2 Intelligence webinar.
ACLA Sues FDA Over Regulation of Laboratory-Developed Tests—in Texas
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
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.
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
FDA Watch: Key Lab Test Clearances of 2023
G2’s list of major FDA approvals includes cancer and liquid biopsy, COVID-19, STI, and neurologic tests.
The Future of Laboratory-Developed Tests
Comments on the FDA’s proposed rule to regulate LDTs as in vitro diagnostic devices reveal mixed reactions.
FDA Watch: Agency Opens New Pathway for STI At-Home Sample Collection Kits
With US STI cases continuing to climb to numbers not seen in decades, a recent FDA approval comes at an opportune moment.
A Successful FDA cGMP Inspection: The Six Steps of a Pre-Inspection Audit
Performing your own audit to verify compliance and identify problems is one key to achieving a successful FDA audit.
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