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Diagnostics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

The system, called Galen Prostate, uses a proprietary algorithm to help pathologists detect and grade prostate cancer in biopsies.

The agency said all tests for the virus must pass through its EUA process, but noted a test could be authorized under a single EUA for use in multiple labs.

Aiming to improve patient access to critical drugs and tests, a group of legislators have started a caucus to shore up bipartisan support for personalized medicine.

The company said the system combined with its Vitros XT 7600 Integrated System completes its suite of Vitros XT Solutions for laboratories.

The specimen discard technology automatically and passively "sidelines" potential contaminants during the blood culture collection process, Kurin said.