Diagnostics Pipeline: Testing for Intestinal Parasites Takes Step Forward
The EasyScreen assay received 510(k) clearance from the Food and Drug Administration earlier this year–but with a catch
FDA-dtet
Evolving Regulations and Guidelines in Genetic Testing
Understanding the regulatory landscape of genetic and genomic testing, and its impact on clinical practice
Esophageal Pre-Cancer Testing Gaining Greater Traction
How three companies are addressing screening challenges with tests that help improve chances of early detection
Agency Authorizes First Fully At-Home COVID-19 Testing Kit
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Agency Temporarily Allows Modifications of Influenza and RSV Tests Without Premarket Notification
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FDA Pulls the Plug on EUA Review of Laboratory Developed Tests for COVID-19
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Agency to Provide Emergency Clearance for Multi-Analyte Respiratory Panels
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HHS Clears the Way for Use of New COVID-19 Tests without FDA Emergency Use Authorization
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FDA Cracks Down on Improper Marketing of SARS-CoV-2 Antibody Tests
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First Enforcement Action for Improper Marketing of SARS-CoV-2 Antibody Tests
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FDA Sets the Bar on Specimen Pooling & Asymptomatic Screening for SARS-CoV-2 Test Development
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After Initial Resistance, Agency Warms to Home COVID-19 Testing
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