Labcorp expands precision oncology portfolio with FDA clearance for melanoma test

USA—Labcorp has received approval from the US Food and Drug Administration (FDA) for its companion diagnostic (CDx), expanding access to precision medicine for patients with advanced melanoma carrying specific BRAF gene mutations.

The approval allows the company’s PGDx elio tissue complete CDx to be used in hospitals and clinical laboratories across the United States to help identify patients who may benefit from targeted treatment.

Precision tests support personalized treatment

The PGDx elio tissue complete CDx is a next-generation sequencing (NGS) in vitro diagnostic (IVD) designed to detect BRAF V600E and BRAF V600K mutations in tumour tissue.

Patients whose cancers carry these mutations may be eligible for treatment with BRAF inhibitors or combination therapies that target both the BRAF and MEK pathways.

By identifying these genetic changes before treatment begins, the test enables clinicians to select therapies that are more likely to benefit individual patients.

This approach reduces uncertainty in treatment selection and supports the broader shift toward personalised cancer care.

Melanoma is the most aggressive form of skin cancer and remains the deadliest. Patients diagnosed with stage IV disease have a five-year survival rate of approximately 16%.

Around half of all melanoma cases carry a BRAF mutation, making genetic testing an important part of treatment planning.

Among these mutations, BRAF V600E is the most common, accounting for an estimated 75% to 90% of all BRAF V600 alterations.

The V600K variant is the second most common and represents roughly 5% to 30% of cases.

Improving access to targeted therapies

Shakti Ramkissoon, vice president and medical lead for oncology at Labcorp, said the approval marks an important step in expanding access to precision oncology.

“Advanced melanoma is an extremely aggressive and life-threatening cancer, but targeted treatments are offering real hope for patients,” Ramkissoon said.

He added that Labcorp’s FDA-approved companion diagnostic will help clinicians identify eligible patients more quickly, allowing them to begin appropriate targeted therapies without unnecessary delays.

Growing role of companion diagnostics

Companion diagnostics are becoming increasingly important as cancer treatment shifts toward therapies tailored to specific genetic profiles.

These tests help determine whether patients are likely to respond to targeted medicines, improving treatment selection while avoiding unnecessary therapies.

According to GlobalData, the global oncology companion diagnostics market is projected to exceed US$3.1 billion by 2030, up from US$1.9 billion in 2022.

 A 2025 GlobalData report also found that oncology remains the leading therapeutic area for both marketed and pipeline companion diagnostic devices.

Russell Bradley, president and general manager of rare cancer assay developer CNSide, previously highlighted the growing importance of these technologies.

He noted that increasingly targeted cancer therapies require equally precise diagnostic tools to match patients with the most appropriate treatment strategy, making companion diagnostics an essential component of modern oncology care.