Untangling Uncertainty: What's Next in Clinical Lab Compliance
Today's Clinical Lab
Join Today's Clinical Lab and a panel of regulatory and industry experts as they explore what’s ahead in laboratory compliance—and what labs need to know right now
CLIA
‘CLIAC Served as a Critical Venue’ for Lab Community, Says ADLM President
Scott Wallask, BA
Anthony Killeen reacts to news that influential committee has been dismantled by the US federal government
Clinically Validated Multiple Sclerosis Multi-Analyte Test Is Now Available in All 50 States
Octave Bioscience
Prior to the MSDA Test, disease management in MS relied primarily on clinical assessments and MRI
Texas Court Strikes Down the FDA's Proposed Regulation of Laboratory-Developed Tests
Association for Molecular Pathology
The FDA LDT rule would have imposed unnecessary burdens on laboratories, adding requirements beyond existing CLIA regulations
Amplified Sciences Earns CLIA Certification for Its First Test to Assess Pancreatic Cancer Risk
Purdue University
Company to commercialize PanCystPro, including establishing an early access program and completing a clinical utility trial in 2025
FDA, CLIA, and ISO—Which Regulations Apply to Your Clinical Lab?
Michael Schubert, PhD
Experts Julie Ballard and Lindsay Strotman help you navigate the complexities of FDA, CLIA, and ISO standards for the clinical lab
Agilent Unveils Biopharma CDx Services Lab to Accelerate Precision Medicine
Agilent Technologies
New CLIA-certified lab ensures seamless transition from early assay development and testing to full companion diagnostics commercialization
Future of FDA’s LDT Rule Uncertain with Latest Supreme Court Decision
Scott Wallask, BA
In overturning the Chevron case, justices diminish the power of federal agencies like the FDA
ACLA Sues the FDA Over Final Rule to Regulate Laboratory-Developed Tests as Medical Devices
Scott Wallask, BA
‘FDA’s final rule is the wrong approach’ for LDTs, ACLA president says
The FDA's Final LDTs Rule Is Out—Now What?
Rachel Muenz
The Mayo Clinic’s Shannon Bennett shares his initial thoughts on the rule and what clinical labs will need to do