Original from: Labcorp
Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced that the U.S. Food and Drug Administration (FDA) has approved Labcorp's PGDx elio® tissue complete CDxopens in a new tab as a companion diagnostic to help identify patients with advanced melanoma with certain BRAF variants who may benefit from treatment with FDA-approved targeted therapies.
Addressing a Critical Need in Advanced Melanoma
Melanoma is the deadliest form of skin cancer, with a five‑year survival rate of just 16% for patients diagnosed with stage IV disease. However, targeted therapies are an important treatment option for patients with advanced melanoma whose tumors have a BRAF alteration. As a companion diagnostic, PGDx elio tissue complete CDx helps clinicians identify which melanoma patients carry these BRAF V600E/K variants and may benefit from treatment with FDA-approved BRAF inhibitors and BRAF/MEK inhibitor combination regimens.
"Advanced melanoma is an extremely aggressive and life‑threatening cancer, but targeted treatments are offering real hope for patients," said Shakti Ramkissoon, M.D., Ph.D., vice president, medical lead for oncology at Labcorp. "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."
A Comprehensive and Scalable Testing Solution
Labcorp's PGDx elio tissue complete CDx is approved for use by qualified healthcare professionals across hospitals and clinical laboratories, supporting broader patient access to high-quality molecular testing. As a kit-based solution, the companion diagnostic can be implemented directly within hospitals and health systems, expanding access to testing while enabling organizations to retain samples and data that may inform future clinical research.
The addition of Labcorp's PGDx elio tissue complete CDx reflects the continued expansion of Labcorp's precision medicine portfolio, which includes comprehensive tissue- and liquid-based oncology diagnostics designed to support personalized care.
Source: Labcorp Announces FDA Approval of Companion Diagnostic Supporting Patients with Advanced Melanoma
