Diagnostics Pipeline: FDA Tweaks Quality System Regs to Align with Global Standards
The FDA is adding International Organization for Standardization (ISO) guidelines to its “good manufacturing” requirements
Keeps You Up-to-Date on New Diagnostic Tests, Testing Trends and Opportunities, and Emerging Test Technologies
The FDA is adding International Organization for Standardization (ISO) guidelines to its “good manufacturing” requirements
Patients’ unfettered access to complex test results can lead to confusion and distress—but generative AI can help.
Crystal Girod, MSc, of Beckman Coulter Life Sciences discusses recent developments in NGS and their impact on clinical diagnostics.
Debate is underway on whether current CLIA review of LDTs properly assesses a test’s likelihood to detect diseases.
Juan Antonio Retamero, MD, shares his thoughts on recent trends in AI and digital pathology, and how they may progress.
The changes proposed in three new draft guidances aim to speed up the process and place less emphasis on older predicate products.
Liron Pantanowitz, MD, PhD, discusses the key issues pathologists face today, and how technology could help.
Artificial intelligence won’t take your job—but what are the real concerns around healthcare AI and its use?
AI is an increasingly useful tool in pathology—but its full value can only be realized in collaboration with human experts.
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.
Genomic sequencing is almost twice as likely to yield a diagnostic result, but lags behind panel testing in speed, cost, and concordance.