Diagnostics Pipeline: 2024 Trends in FDA Approvals
In vitro diagnostic products approved by the U.S. Food and Drug Administration in 2024 show a continued move toward rapid and point-of-care tests
Clinical Diagnostics Insider
(formerly Diagnostic Testing and Emerging Technologies)
Keep up to date on new and emerging diagnostic tests, testing trends and opportunities, and disruptive technologies
A Closer Lab-Patient Connection
Patient access to data from the clinical lab is increasing. What does this mean for those generating it?
New and Improved: The Latest Research in Disease Screening
New ideas and innovations look beyond conventional screening options to facilitate improved disease diagnosis and patient outcomes
Accessions Disappearing or Not Getting Billed?
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5 ways to break down bureaucracies to get payer contracts
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FDA Watch: Agency Targets Sale of IVD Reagents without Premarket Approval
Distribution of diagnostics and devices without premarket approval has featured prominently on the FDA’s enforcement priority list this year. The agency has issued seven warning letters related to premarket approval in 2019 after issuing just one such warning letter in all of 2018.
Utilization: Study Finds that Distribution of Free Self-Tests Increases HIV Testing & Awareness
Internet distribution of free HIV self-tests can boost testing, promote awareness among high-risk individuals resulting in less incidence of transmitting the disease. These are the key findings of a newly published Centers for Disease Control and Prevention (CDC) study.
Precision Medicine: Are Primary Care Providers Prepared to Interpret Genetic Testing Results?
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Pay rates, vacations while recovering, gig economy
Department of Labor enters final stage of update to ‘regular rate’ rule under FLSA. As we have discussed previously in these updates, the Department of Labor has been working to update the definition
FDA Watch: Agency Resounds the Alarm on Biotin Test Interference
In early November 2019, the U.S. Food and Drug Administration (FDA) updated a previous safety communication about the potential of biotin to significantly interfere with diagnostic tests. The update reiterates the warning
