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
Medical director William G. Finn, MD, discusses key trends, challenges, and opportunities related to the expansion of at-home testing.
Is at-home sample collection the solution to lagging cancer screening uptake—or does this approach introduce a new set of challenges?
Several methods are being developed that improve the ability to rapidly identify organisms and report susceptibility results.
A brief overview of antimicrobial susceptibility testing, current methods used, and new methods on the horizon.
Polygenic risk scores may offer new screening and risk stratification options for cardiovascular disease—but how valuable are they?
A pandemic-related drop in cancer diagnoses could spell long-term trouble for patients and providers.
Artificial intelligence models have a valuable role to play in each phase of the total testing process.
Genomic epidemiology can provide insights into pathogen transmission and evolution—and facilitate better countermeasures against infectious disease.
Approval for OTC use of a urine drug test that can be performed by non-CLIA facilities could help expand accessibility, expert says.
Patients’ unfettered access to complex test results can lead to confusion and distress—but generative AI can help.