Fighting the FDA’s Final Rule on LDTs
CEO Laurie Menser discusses the Association for Molecular Pathology’s court case against the FDA’s rule on laboratory-developed tests.
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Getting Started with the FDA’s New LDT Rule
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
Transitioning the Clinical Lab
What clinical laboratory professionals need to know about healthcare provision for transgender and nonbinary patients
LDTs Around the World
Curious about how laboratory-developed tests are regulated in other countries? We compare in-house test guidance across six regions
Omicron Surge Creates Nationwide Shortage of COVID-19 Tests
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Leading COVID-19 Test Makers Say Their Products Can Detect New Omicron Variant
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Becton Dickinson Gets EUA for At-Home COVID-19 Antigen Test Providing Results by Phone
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Resurgence of COVID-19 Cases Threatens to Derail Recovery of Core Business
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COVID-19 Fuels Massive & Sustainable Growth in Molecular Diagnostics
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Employers Show Signs of Hesitation on COVID-19 Return to Work Testing
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Investment Returns on the Federal Enforcement Dollar Continue to Drop
From - Laboratory Industry Report
The business of enforcing federal health care fraud laws isn't as robust as it used to be. While revenues have…
Business Trends: Commercial Testing Companies ‘Sell’ Health Screenings
From - Laboratory Industry Report
Several companies market an array of preventive tests directly to consumers. Are these companies and tests legit? What does…
FDA Watch: Agency Issues New Guidance on Biotin Interference Testing
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