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FDA Approves Labcorp's PGDx Elio Tissue Complete CDx for Advanced Melanoma

Published

10 August 2026

Topic

opportunities

Sectors

Biotech

Geography

United States

Source

Read at dermatologytimes.com

Verified

Fusion42 · 25 August 2026 · Fusion42 review

The FDA has approved Labcorp's PGDx elio tissue complete CDx as a companion diagnostic test to identify BRAF V600E/V600K mutations in advanced melanoma patients, aiding in the timely selection of targeted BRAF and BRAF/MEK therapies. The test uses a 505-gene NGS panel with strong analytical performance, enabling rapid in-house testing in hospitals for precise and quick treatment decisions.

This Wire brief sits within Fusion42's coverage of Biotech, and 3 sources have reported it.

◆ The Wire takeaway

You can now offer clinicians a rapid, hospital-deployable test that clearly identifies melanoma patients eligible for BRAF-targeted therapies. This opens direct pathways to hospitals demanding quick genetic insights for personalised cancer treatment.

Coverage

3 sources · 10 Aug 2026

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Topics

BiotechFDA-approvaladvanced-melanomacompanion-diagnosticNGS-testingBRAF-mutations