Labcorp (NYSE: LH), a provider of comprehensive laboratory services, disclosed on Monday that it has received U.S. Food and Drug Administration approval for its PGDx elio tissue complete CDx as a companion diagnostic to identify patients with advanced melanoma carrying certain BRAF variants who may benefit from targeted therapies.
This test is designed to identify BRAF V600E/K variants, helping clinicians determine which patients may be eligible for FDA-approved BRAF inhibitors and BRAF/MEK inhibitor combinations.
The kit-based diagnostic can be implemented by qualified healthcare professionals in hospitals and clinical laboratories, supporting broader access to molecular testing. The approval expands Labcorp's precision medicine portfolio of tissue- and liquid-based oncology diagnostics.
Guardant Health wins FDA approval for Guardant360 CDx in advanced breast cancer
Agilent launches S540MD slide scanner system in US
Kali Therapeutics' KT501 Investigational New Drug application cleared by US FDA
NeuroSense reveals strategy to advance PrimeC toward potential ALS approval
UCB agrees with US government to lower medicine costs and strengthen US manufacturing
Karyopharm seeks accelerated FDA approval for selinexor–ruxolitinib in myelofibrosis