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?
Advancements in Antimicrobial Susceptibility Testing: Part 2
Several methods are being developed that improve the ability to rapidly identify organisms and report susceptibility results.
Diagnostics Pipeline: FDA Opens Path for Blood Tests Assessing Genetic Cancer Risk
First marketing authorization of a blood test assessing genetic variants related to cancer opens the door for clearance of similar tests.
Advancements in Antimicrobial Susceptibility Testing: Part 1
A brief overview of antimicrobial susceptibility testing, current methods used, and new methods on the horizon.
Polygenic Risk Scores: A Cardiovascular Conundrum
Polygenic risk scores may offer new screening and risk stratification options for cardiovascular disease—but how valuable are they?
Expert Q&A: Enhancing Clinical Labs through Advanced Data Analytics
Lisa-Jean Clifford of Gestalt Diagnostics, discusses key trends, challenges, and solutions in data analytics for clinical labs.
Lost Ground: Cancer Screening in the COVID-19 Era
A pandemic-related drop in cancer diagnoses could spell long-term trouble for patients and providers.
AI: With the Lab Every Step of the Way
Artificial intelligence models have a valuable role to play in each phase of the total testing process.
Profiling Pathogens for Public Health
Genomic epidemiology can provide insights into pathogen transmission and evolution—and facilitate better countermeasures against infectious disease.
The Diagnostics Pipeline: FDA Approves First Ever Fentanyl Test Strips for OTC Use
Approval for OTC use of a urine drug test that can be performed by non-CLIA facilities could help expand accessibility, expert says.
A 21st Century Response to the Cures Act
Patients’ unfettered access to complex test results can lead to confusion and distress—but generative AI can help.
