LuminoDx Earns CAP Accreditation for Diagnostic Testing Facility
The accreditation covers liver health diagnostics, including Hepatotrack, a molecular diagnostic liquid biopsy that is predictive of acute liver rejection post-liver transplant.
Category: Lab Management
Lab Management
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Lab Management
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Labcorp Reports Strong Q3 Performance with 8.6% Revenue Growth
The laboratory services company updates full-year guidance following continued momentum in diagnostics and central laboratory businesses.
Lab Management
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FDA Issues Finalized Guidance on Emergency Use of Unapproved Diagnostic Tests
The guidance establishes a formal framework for how the FDA will exercise enforcement discretion regarding unapproved diagnostic tests in the event of future public health emergencies.
Accreditation
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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
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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
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Managing Reagent Variation
Lot-to-lot reagent inconsistencies can have significant effects on patient test results.
Company News
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HealthTrackRx Opens $45.5 Million Facility to Double Infectious Disease Testing Capacity
The new Louisville campus aims to deliver next-morning molecular diagnostic results to 5 million patient samples annually nationwide.
Resource Center
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Why Your Sample Management System May Be Slowing Discovery
Your lab’s success hinges on a reliable sample management system. But outdated tools may be costing you time, accuracy, and compliance. This guide helps you uncover whether your current system is built for today’s challenges or holding your team back. Take the five-question test, score your solution, and see if it’s time for a smarter approach.