A Closer Lab-Patient Connection
Patient access to data from the clinical lab is increasing. What does this mean for those generating it?
Diagnostic Testing and Emerging Technologies
Keeps You Up-to-Date on New Diagnostic Tests, Testing Trends and Opportunities, and Emerging Test Technologies
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
A Lasting Impact: COVID-19 and Cancer Screening
Several years after the onset of the COVID-19 pandemic, labs are still dealing with the effects of missed and delayed screenings
FDA Watch: Agency Exempts Dozens of Tests from 510(k) Review
On Dec. 30, 2019, the U.S. Food and Drug Administration (FDA) published a final order exempting dozens of Class I and Class II medical devices that previously required 510(k) submission from 510(k) premarket review
Finding the “Backdoor” into Payer Networks
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Targeted Genetic Risk-Based Prostate Cancer Screening Would Save the Most Lives at the Best Costs: UK Study
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Standard Pathology Tests Outperform Molecular Subtyping in Bladder Cancer Tumor Classification
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AACC Calls on Laboratories to Take Measures to Minimize Risks of Biotin Interference
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New overtime rule now in effect
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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.
