FDA Watch: Scientists Ask Agency to Rescind Approval for Opioid Management Test
Experts—including those in genetics and device regulation—say the AvertD assay did not predict risks of abuse ‘any better than chance’
Clinical Diagnostics Insider
(formerly Diagnostic Testing and Emerging Technologies)
Keep up to date on new and emerging diagnostic tests, testing trends and opportunities, and disruptive technologies
Syndromes Without a Name Bring Labs an Uphill Battle
In an era when genetic and genomic testing are theoretically affordable and accessible, why do so many patients remain undiagnosed?
Advances in Point of Care Tech Alter the Genetic Testing Landscape
How are advances in point-of-care testing altering the genetic testing landscape, and what does this mean for the clinical lab?
Expert Q&A: What’s Next in Next-Generation Sequencing?
Crystal Girod, MSc, of Beckman Coulter Life Sciences discusses recent developments in NGS and their impact on clinical diagnostics.
FDA’s LDT Proposal Raises Questions About Clinical Validity
Debate is underway on whether current CLIA review of LDTs properly assesses a test’s likelihood to detect diseases.
Expert Q&A: Key Developments in AI and Digital Pathology
Juan Antonio Retamero, MD, shares his thoughts on recent trends in AI and digital pathology, and how they may progress.
The Diagnostics Pipeline: FDA Moves to Modernize 510(k) Process for New Lab Tests & Devices
The changes proposed in three new draft guidances aim to speed up the process and place less emphasis on older predicate products.
Expert Q&A: Challenges in Pathology and Potential Solutions
Liron Pantanowitz, MD, PhD, discusses the key issues pathologists face today, and how technology could help.
Seeing Past the AI Hype
Artificial intelligence won’t take your job—but what are the real concerns around healthcare AI and its use?
AI: The Newest Member of the Lab Team?
AI is an increasingly useful tool in pathology—but its full value can only be realized in collaboration with human experts.
Expert Q&A: Developments in Noninvasive Prenatal Testing
Diana W. Bianchi, MD, discusses how NIPT has evolved, key challenges, as well as her team’s research on using these tests to detect cancer.
Which Test? Choosing the Best Approach to Diagnosing Rare Disease
Genomic sequencing is almost twice as likely to yield a diagnostic result, but lags behind panel testing in speed, cost, and concordance.
Streamlining Lab Operations with Software Automation
Using LIMS and no-code solutions can unlock opportunities for efficiency.
