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
CLIA
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
ADLM President: 'LDTs Should Remain under CLIA'
Scott Wallask, BA
Octavia Peck Palmer reacts to the FDA’s new final rule on lab-developed tests
CMS Update Raises Standards for Clinical Laboratories under CLIA
Jesse L. Day, MHA, BSc, MLS(ASCP)CM
Effective January 28, the updated rules address recent questions around nursing degree equivalency and the status of DCLS professionals
Response: FDA Proposes Rule to Ensure Safety and Effectiveness of LDTs
Kathryn Golab, MLS(ASCP)CM
The proposed change in LDT regulation may not be as straightforward as it seems
What Can We Do about Clinical Workforce Shortages?
ASCP
ASCP initiatives to alleviate labor shortages focus on visibility, recruitment and retention, and DEI