NEW YORK – Roche subsidiary Foundation Medicine announced Friday that its tissue-based FoundationOne CDx test has received approval from the US Food and Drug Administration for use as a companion diagnostic with Day One Biopharmaceuticals' Ojemda (tovorafenib) in pediatric patients.
The next-generation sequencing-based test is approved for use in patients 6 months of age or older with relapsed or refractory pediatric low-grade glioma who have a BRAF fusion or rearrangement, or a BRAF V600 mutation. Ojemda is a type II RAF inhibitor that received FDA accelerated approval in April.
The approval is Foundation's first companion diagnostic indication exclusively for pediatric patients, the company noted in a statement.
FoundationOne CDx uses NGS to detect substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements using DNA from formalin-fixed, paraffin-embedded tumor tissue samples. It also detects genomic signatures such as microsatellite instability and tumor mutational burden.
"Our high-quality tissue-based companion diagnostic test is uniquely capable of detecting both BRAF V600 mutations and fusions which enables providers to gain the complete genomic picture of their patient’s tumor and guide treatment decision-making," Foundation Chief Medical Officer Mia Levy said in a statement.