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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.
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.
December 2023 Labs in Court
A settlement for kickback allegations, prison time for lab owners convicted of COVID-19 fraud, and 10x Genomics gets OK for lawsuit.
Procedural Coding Changes to Note for 2024
Key 2024 coding changes for laboratories and tips for ensuring proper implementation into chargemasters and fee schedules.
Who Needs to Follow the OSHA BBP Standard in the Lab?
Which staff members lab professionals should consider when developing their exposure control plans to ensure OSHA compliance.
Solving Lab Safety Challenges, Both New and Old
Dan J. Scungio, MLS (ASCP), SLS, CQA (ASQ), discusses recent developments in lab safety and how to address key challenges.
How ‘Voluntary’ Safety Standards Impact OSHA Compliance
Lab leaders need to be aware that in some cases, following additional standards such as ANSI may not be voluntary at all.
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.