FDA Approves Melanoma BRAF Companion Test - Summary - MDSpire
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FDA Approves Melanoma BRAF Companion Test

The assay is indicated to identify patients with advanced melanoma who have BRAF V600E or BRAF V600K variants and may benefit from FDA-approved targeted therapies.

  • By

  • Kathryn Wighton

  • August 10, 2026

  • 1 min

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Objective:

To announce the FDA approval of PGDx elio tissue complete CDx as a companion diagnostic for advanced melanoma.

Approach:
  • Diagnostic Technology: PGDx elio tissue complete CDx is a qualitative in vitro diagnostic that uses next-generation sequencing to analyze DNA from tumor tissue.
Key Findings:
  • The test identifies patients with advanced melanoma who have BRAF V600E or BRAF V600K variants.
  • Melanoma has the highest mortality rate among skin cancers, with a 5-year survival rate of 16% for stage IV melanoma.
Interpretation:

Conclusion:

Sources:

Original Source(s)

FDA Approves Melanoma BRAF Companion Test

  • by Kathryn Wighton

  • August 10, 2026

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