Labcorp announced that the US Food and Drug Administration approved PGDx elio tissue complete CDx as a companion diagnostic to identify patients with advanced melanoma who have BRAF V600E or BRAF V600K variants.

In a press release, the company noted melanoma has the highest mortality rate among skin cancers, and patients diagnosed with stage IV melanoma have a 5-year survival rate of 16%. According to the company, patients identified by the companion diagnostic may benefit from US Food and Drug Administration-approved BRAF inhibitors and BRAF/MEK inhibitor combination therapies.

PGDx elio tissue complete CDx is a qualitative in vitro diagnostic based on next-generation sequencing that analyzes DNA extracted from formalin-fixed, paraffin-embedded tumor tissue. The assay uses hybridization-based capture technology to identify single-nucleotide variants, small insertions and deletions, copy-number amplifications, and translocations. Qualified health care professionals in hospital and clinical laboratory settings may use PGDx elio tissue complete CDx under its US Food and Drug Administration-approved indication. 

Source: Labcorp