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Esophageal Pre-Cancer Testing Gaining Greater Traction

By Ron Shinkman | Oct 29, 2024 | 1 min read

How three companies are addressing screening challenges with tests that help improve chances of early detection

An elderly male patient holds a hand to his throat as he speaks with his doctor, illustrating the concept of throat problems and potential esophageal cancer.

Has Your AI Been Validated?

By Michael Schubert, PhD | Oct 28, 2024 | 1 min read

Many artificial intelligence-based medical devices have not undergone clinical validation—but what does this mean for the lab?

A laboratory technician in a white lab coat works at a computer displaying digital images of cells, gels, and DNA structural models.

Diagnostics Pipeline: Recent FDA Approvals Aim to Make HPV Testing for Women More Accessible

By Ron Shinkman | Sep 25, 2024 | 1 min read

Expansion of use for two assays gives patients the option to self-collect specimens at home and in the clinic, which may help address gaps in screening

A female patient in a hijab meets with her female doctor.

First Saliva COVID-19 Test Secures FDA Approval

By Glenn S. Demby | Apr 19, 2020 | 1 min read

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Serology Testing Critical to COVID-19 Survival & Post-Crisis Transition

By Glenn S. Demby | Apr 19, 2020 | 1 min read

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Are Rapid Immunodiagnostic Tests for COVID-19 Ready for Prime Time?

By Glenn S. Demby | Apr 19, 2020 | 1 min read

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How Laboratories Are Developing New Coronavirus Diagnostic Tests at Record Speed

By Glenn S. Demby | Mar 24, 2020 | 1 min read

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SARS-CoV-2 Detection Assays Highlight List of Key New Product Approvals

By Glenn S. Demby | Mar 24, 2020 | 1 min read

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FDA Finalizes CLIA Waiver Guidance for Approval of New In Vitro Diagnostic Devices

By Glenn S. Demby | Mar 23, 2020 | 1 min read

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Top of the News: CMS Issues New Guidance for Laboratories Performing Coronavirus Testing

By Glenn S. Demby | Mar 4, 2020 | 3 min read

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...