Foundation Medicine has secured US Food and Drug Administration (FDA) approval for its FoundationOne CDx test as a companion diagnostic to Day One Biopharmaceuticals’ Ojemda (tovorafenib).
This approval enables its use for patients aged six months and older with relapsed or refractory paediatric low-grade glioma (pLGG) associated with specific BRAF alterations, including fusions, rearrangements, or the BRAF V600 mutation.
FoundationOne CDx is the first FDA-approved companion diagnostic for Ojemda, facilitating personalised treatment decisions for paediatric patients.
Ojemda is a type II RAF inhibitor designed for the treatment of pLGG. The combination of Ojemda and FoundationOne CDx is expected to enhance access to targeted therapies for paediatric patients with limited treatment options.
Foundation Medicine chief medical officer Mia Levy said: “Foundation Medicine is proud to partner with Day One to help healthcare providers connect paediatric patients and families with this treatment option.
“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.”
FoundationOne CDx uses tissue samples to analyse more than 300 cancer-related genes, with the intention to offer comprehensive genomic insights that guide targeted therapeutic approaches.
Foundation Medicine, which has expertise in genomic profiling, is said to have sequenced over 2,200 paediatric central nervous system tumours. The company remains the sole provider of FDA-approved tissue and blood-based genomic profiling tests.
Additionally, it claims to hold 50% of all approved companion diagnostic indications for next-generation sequencing (NGS) tests in both the US and Japan.
Foundation Medicine said that the latest approval expands treatment opportunities for patients having BRAF-altered paediatric low-grade glioma. The approval also represents the company’s first paediatric-specific companion diagnostic indication.
FoundationOne CDx functions as an in vitro diagnostic device powered by NGS technology. It detects a broad range of genomic alterations, including substitutions, insertions, deletions, copy number changes, and specific gene rearrangements.
The test also identifies genomic signatures such as microsatellite instability (MSI) and tumour mutational burden (TMB). These capabilities enable the identification of patients eligible for targeted therapies in accordance with approved therapeutic product labelling.
FoundationOne CDx requires formalin-fixed, paraffin-embedded tumour tissue specimens and is available by prescription only. It also serves a dual purpose by offering broader tumour mutation profiling, which aids oncologists in developing treatment plans consistent with professional oncology guidelines.
In late 2024, Foundation Medicine received FDA approval for FoundationOne Liquid CDx as a companion diagnostic for Itovebi (inavolisib), aiding in the identification of patients with advanced breast cancer.
