Category: Lab Management

Lab Management

Hawaii Dept of Health Issues Violations to Four Companies Over Illegal Direct-to-Consumer Lab Testing

State regulators say the companies collected specimens without authorized provider orders, violating Hawaii law.

Lab Management

Diagnostics Trailblazer Recognized With AdvaMedDx’s New Lifetime Award

The recipient is recognized for contributions to molecular diagnostics and women's health screening technologies.

Lab Management

Lab Sets Guinness World Record for DNA Sequencing Speed

Teams complete whole human genome sequencing and analysis in under four hours, demonstrating potential for same-day NICU workflows.

Accreditation

Quanterix Accelerator Laboratory Gains New York State Clinical Lab Permit

The CLIA-certified facility is now authorized to operate in all 50 states, expanding biomarker testing capabilities nationwide.

Compliance

FDA Withdraws Final Rule Regulating Lab-Developed Tests as Medical Devices

The action follows a federal court order that vacated the 2024 rule, reinstating FDA’s prior policy of enforcement discretion for laboratory-developed tests.

Proficiency Testing

Managing Reagent Variation

Lot-to-lot reagent inconsistencies can have significant effects on patient test results.

Company News

College of American Pathologists Names Interim CEO

The new interim CEO currently serves as senior vice president and chief operating officer at the organization.

Resource Center

Global Study Reveals Escalating Antimicrobial Resistance Patterns

Analysis of international surveillance data shows rising resistance to last-line antibiotics, with significant regional variations in treatment outcomes.