Labcorp’s companion diagnostic (CDx) to identify advanced melanoma patients with certain BRAF variants who may benefit from targeted therapies has secured US Food and Drug Administration (FDA) approval.
Approved for use across hospitals and clinical laboratories, the North Carolina-based company’s PGDx elio tissue complete CDx is a next-generation sequencing (NGS) in vitro diagnostic (IVD) that is designed to detect BRAF V600E and V600K melanoma mutations – both melanoma patient cohorts who may benefit from treatment with BRAF inhibitors and BRAF/MEK inhibitor combination regimens.
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Melanoma is the deadliest form of skin cancer, with a five‑year survival rate of 16% for patients diagnosed with stage IV disease. Around 50% of melanomas harbour a BRAF mutation, with the BRAF V600E mutation representing the most frequent type, making up around 75% to 90% of all BRAF V600 changes. Meanwhile, V600K is the second most common mutation, accounting for between 5% and 30% of cases.
Commenting on PGDx elio’s FDA approval, Shakti Ramkissoon, vice president, medical lead for oncology at Labcorp, said: “Advanced melanoma is an extremely aggressive and life‑threatening cancer, but targeted treatments are offering real hope for patients.
“Labcorp’s FDA‑approved companion diagnostic improves access to these therapies by allowing clinicians to confirm which patients may be eligible for and can start receiving those treatments as soon as possible.”
CDx’s have an increasingly important role to play in precision oncology. According to GlobalData analysis, the overall diagnostics market in oncology will be worth more than $3.1bn by 2030, up from $1.9bn in 2022, with a GlobalData report from 2025 revealing that oncology is currently the top indication both for pipeline and marketed CDx devices.
Reflecting on the advance of CDx’s in oncology, Russell Bradley, president and general manager of rare cancer assay developer CNSide, previously told Medical Device Network: “Increasingly targeted approaches to treating cancer require precise targeting tools to facilitate the best match between a specific patient and the optimal therapeutic strategy. This is where CDx is a critical component of the overall assessment.”
