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
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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
Now Even the “Good” Tests Are Coming Under Fire
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Agency Clears Dozens of New COVID-19 Diagnostic Tests in Record Time
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First Saliva COVID-19 Test Secures FDA Approval
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Serology Testing Critical to COVID-19 Survival & Post-Crisis Transition
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Are Rapid Immunodiagnostic Tests for COVID-19 Ready for Prime Time?
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How Laboratories Are Developing New Coronavirus Diagnostic Tests at Record Speed
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SARS-CoV-2 Detection Assays Highlight List of Key New Product Approvals
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FDA Finalizes CLIA Waiver Guidance for Approval of New In Vitro Diagnostic Devices
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Top of the News: CMS Issues New Guidance for Laboratories Performing Coronavirus Testing
On Feb. 4, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) clearance for the first test approved in the US for detecting the novel coronavirus. Developed by the US Centers for Disease Control and Prevention (CDC) using sequencing...
FDA Watch: Agency Grants Emergency Clearance for CDC Novel Coronavirus Detection Test
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