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FDA Watch: OraSure’s Collection Device for Cobas STI Testing Receives Approval

FDA Watch: OraSure’s Collection Device for Cobas STI Testing Receives Approval

by Ron Shinkman | Aug 24, 2026 | Essential, FDA-lca, FDA-lir, FDA-nir, Lab Industry Advisor

At-home sample collections can be mailed to a clinical laboratory

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GRAIL’s Moves with MCED Test Illustrate Direct-to-Consumer Surge

GRAIL’s Moves with MCED Test Illustrate Direct-to-Consumer Surge

by G2 Intelligence Staff | May 13, 2026 | Clinical Diagnostics Insider, Emerging Tests-dtet, Testing Trends-dtet

By partnering with Hims & Hers and Epic, GRAIL bypasses traditional lab test arrangement

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Diagnostics Pipeline: Postpartum Lab Panel Launched by Trellis Health

Diagnostics Pipeline: Postpartum Lab Panel Launched by Trellis Health

by Ron Shinkman | Sep 26, 2025 | Clinical Diagnostics Insider, DTC-dtet, Emerging Tests-dtet, Testing Trends-dtet

The intent of the at-home testing is to identify and treat issues such as postpartum depression and vitamin deficiencies

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FDA Approves Teal Wand as First At-Home Cervical Cancer Screening

FDA Approves Teal Wand as First At-Home Cervical Cancer Screening

by Ron Shinkman | Jun 27, 2025 | Clinical Diagnostics Insider, DTC-dtet, Emerging Tests-dtet, FDA-dtet, Testing Trends-dtet

Teal Health, the company manufacturing and distributing the test, says thousands of women are already on a waiting list for the assay

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MeMed Sepsis Test Gains Breakthrough Device Designation

MeMed Sepsis Test Gains Breakthrough Device Designation

by Ron Shinkman | Jan 31, 2025 | Essential, FDA-lca, Lab Industry Advisor

The 15-minute assay to detect sepsis and assess its severity and risk is expected to get full FDA approval by 2026

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