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
Lab Companies Scramble to Bring Coronavirus Detection Tests to Market
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Doing What We’ve Always Done
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Test Quality: New Study Casts Doubt on Whole Exome Sequencing’s Accuracy in Diagnosing Genetic Disorders
Depending on the reporting laboratory, patients who undergo whole exome sequencing may receive false negatives or incomplete test results. That is the finding of a new study published in Clinical Chemistry
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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