FDA approves Labcorp PGDx elio tissue complete CDx for BRAF-targeted therapy selection in advanced melanoma
- nuaxia
- 4 days ago
- 2 min read
The next-generation sequencing companion diagnostic identifies BRAF V600E and V600K variants, helping clinicians determine which melanoma patients may be eligible for FDA-approved BRAF or BRAF/MEK targeted therapies.
The US Food and Drug Administration (FDA) has approved Labcorp’s PGDx elio tissue complete CDx as a companion diagnostic to identify melanoma patients with BRAF V600E or V600K variants who may benefit from FDA-approved BRAF inhibitors or BRAF/MEK inhibitor combinations.
The approval provides hospitals and clinical laboratories with a kit-based next-generation sequencing option for identifying patients whose tumours carry actionable BRAF variants and informing targeted treatment selection.
Field | Content |
Alert Type | Drug Approval |
Drug Name | PGDx elio tissue complete CDx |
Indication | Companion diagnostic for identifying melanoma patients with BRAF V600E or BRAF V600K variants who may benefit from FDA-approved BRAF inhibitors or BRAF/MEK inhibitor combinations, in accordance with the approved therapeutic product labelling. (PR Newswire) |
Therapy Area(s) | Oncology; Melanoma; Precision medicine |
Geography | United States (FDA) |
What Happened | On 10 August 2026, Labcorp announced FDA approval of PGDx elio tissue complete CDx as a companion diagnostic for melanoma patients with BRAF V600E or V600K variants. The tissue-based next-generation sequencing assay detects genomic alterations from formalin-fixed, paraffin-embedded tumour samples and can now be used to identify melanoma patients who may benefit from FDA-approved BRAF inhibitors or BRAF/MEK inhibitor combinations. (PR Newswire) |
Why It Matters | BRAF status is clinically relevant when selecting targeted treatment for patients with advanced melanoma. The approval gives qualified healthcare professionals another FDA-approved method for identifying BRAF V600E/K-positive patients who may be eligible for established targeted therapies, supporting biomarker-directed treatment decisions. (PR Newswire) |
Supporting Context | PGDx elio tissue complete CDx is a qualitative next-generation sequencing in vitro diagnostic capable of detecting single nucleotide variants, small insertions and deletions, copy-number amplifications and translocations. As a kit-based assay, it can be implemented within hospitals and clinical laboratories rather than requiring samples to be sent exclusively to a central laboratory. (PR Newswire) |
Key Takeaway | FDA approval expands access to companion diagnostic testing that can identify BRAF V600E/K-positive melanoma patients for whom BRAF-targeted treatment may be appropriate. |
Primary Source | |
Relevant Date | 10 August 2026 |
Discover how nuaxia can support your next medical education initiative:
Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector
Contact us on: support@nuaxia.com
Comments