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Labcorp Companion Diagnostic for BRAF-Mutated Melanoma Gets FDA Approval

Published

10 August 2026

Topic

opportunities

Sectors

Biotech

Geography

United States

Source

Read at precisionmedicineonline.com

Verified

Fusion42 · 25 August 2026 · Fusion42 review

The US FDA approved Labcorp's PGDx elio tissue complete as a companion diagnostic for detecting BRAF V600E and V600K mutations in melanoma patients.

This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it.

◆ The Wire takeaway

You now face a clearer path to US melanoma market access with Labcorp's newly FDA-approved BRAF companion diagnostic. This removes testing uncertainty, letting you align product development or partnerships around a validated diagnostic standard.

Coverage

2 sources · 10 Aug 2026

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Topics

Biotechcompanion-diagnosticfda-approvalbraf-mutationmelanomalabcorp