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Roche Scores First European IVDR Approval for Diagnostic Tests

by Glenn S. Demby | Jan 26, 2023 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

The test manufacturer is the first to gain IVDR certification for a companion diagnostic under the new regulation.

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Early in Pandemic, HIV Testing Dropped Sharply, but Quickly Rebounded

by Glenn S. Demby | Jan 26, 2023 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Testing Trends-dtet

A recent CDC report concludes that disruptions to HIV testing due to the COVID-19 pandemic compromised America’s ability to prevent the disease.

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New Cancer Diagnostic Tests Stand Out

New Cancer Diagnostic Tests Stand Out

by Rachel Muenz | Jan 24, 2023 | News, Open Content

Key Dx announcements last week involved companion diagnostics, liquid biopsy assays, and an RUO leukemia test.

The Promise of Mobile Photoacoustic Imaging

The Promise of Mobile Photoacoustic Imaging

by Del Williams | Jan 20, 2023 | Industry Perspectives, Open Content

The flexibility of compact, mobile, photoacoustic imaging equipment on wheels is helping to advance groundbreaking medical research, diagnostics, and treatment.

Empowered Dx in Hot Water with FDA Again Over COVID-19 Test Kits

by Glenn S. Demby | Jan 19, 2023 | Essential, FDA-nir, National Lab Reporter

At the end of 2022, the agency sent a new warning letter to Empowered for unauthorized distribution of COVID-19 test kits.

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