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|2 min read

What Clinical Labs Creating LDTs Need to Know About the U.S. FDA Final Rule

A Strategic Guide for Clinical Labs to Stay Compliant and Thrive Amid Regulatory Changes
byDNA Genotek
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: Image of Congress with a backdrop of a hundred-dollar bill. PAMA cuts to clinical lab services were avoided by a recent vote in Congress.
|2 min read

PAMA Cuts Averted Again for Clinical Lab Services

ACLA applauds congressional action to delay Medicare decreases and urges long-term reform
byScott Wallask
Illustration of a network of different health care and laboratory symbols against a blue background to represent data management and data analysis in clinical research.
|2 min read

CRDSA Announces New Standards for Clinical Trial Data Reuse

The new standards aim to facilitate responsible sharing and use of anonymized individual patient data from clinical studies to support research and accelerate the discovery and delivery of new therapies
byClinical Research Data Sharing Alliance
iStock
|1 min read

Optimize LC-MS Performance with Ultrapure Water Solutions

Discover how ultrapure water enhances sensitivity, traceability, and reliability in LC-MS for clinical laboratories
byMilliporeSigma
iStock
|1 min read

Maximize Lab Operations with an Efficient Water Purification System

Improve patient care with laboratory water systems–reducing maintenance burdens, and ensuring reliable test results
byMilliporeSigma
Two clinical laboratory scientists wearing PPE in the laboratory hold a clipboard and review the milestones toward the new FDA LDT Final Rule.
|3 min read

Navigating FDA’s LDT Final Rule: Key Terminology Every Clinical Lab Should Know

As the first milestone of the new LDT Final Rule approaches, here are the key FDA terms laboratories need to understand
byShannon Bennett, MS, MBA
Portrait of Judith Su wearing a white lab coat at the University of Arizona’s Little Sensor Lab.
|3 min read

Researchers Take Power and Efficiency of Biological Sensing to Record Level

 The approach could lead to better health outcomes and diagnostics
Illustration of a human face with smoke stacks releasing polluted air into the human face, representing air quality issues.
|4 min read

Improving Indoor Air Quality in Clinical Laboratories: Best Practices for Safety and Compliance 

A guide to indoor air quality in the clinical lab—understanding the hazards, monitoring risk, and taking action to prevent issues
byMichael Schubert, PhD
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|1 min read

Improve Experimental Efficiency with Advanced Water Purification

Integrated high-purity water systems can enhance accuracy, reduce downtime, and optimize workflows
byELGA
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Photo of a multiracial team of clinical laboratory scientists wearing PPE and working in a CLIA-certified laboratory environment on companion diagnostics.
|2 min read

Agilent Unveils Biopharma CDx Services Lab to Accelerate Precision Medicine

New CLIA-certified lab ensures seamless transition from early assay development and testing to full companion diagnostics commercialization
byAgilent Technologies
Rubber stamp stating FDA approved
|2 min read

FDA Predetermined Change Control Plans May Aid LDT Modifications

A new PCCP draft guidance outlines what elements the agency expects in these plans
byKarin Hughes, PhD
ISO standards shown in a schematic drawing design
|1 min read

A2LA Accredits First Clinical Laboratory in US to New Version of ISO 15189 

 ADL Health meets requirements of ISO 15189:2022, the latest version of the standard 
byA2LA
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When the Sample Waits: Pre-Analytical Variability in Multi-Analyte Blood Testing

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Clinical scientist working with a clinical analyzer

Protecting Clinical Lab Uptime

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Lessons Learned from a Successful Digital Pathology Deployment at CorePath Laboratories

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Preserving Sample Integrity When Processing is Delayed

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