Foundation Medicine’s tissue-based test is said to be the first and only CGP test to receive FDA approval as a CDx across a group of targeted therapies
FoundationOne CDx is an NGS-based diagnostic test (Credit: Shameer Pk from Pixabay.)
Foundation Medicine has received the US FDA approval for its FoundationOne CDx as a companion diagnostic to identify melanoma patients eligible for treatment with two groups of therapeutics.
The two groups include anti-BRAF monotherapies that target BRAFV600E mutations and combination therapies that inhibit BRAF/MEK to target BRAFV600E or V600K mutations.
FoundationOne CDx is a next-generation sequencing (NGS) based in-vitro diagnostic test intended for advanced cancer patients, only for prescription use.
It analyses 324 genes, along with microsatellite instability (MSI) and tumour mutational burden (TMB) genomic signatures, using DNA isolated from FFPE tumour tissue specimens.
In addition, the test provides health care professionals with tumour mutation profiling for patients with solid malignant neoplasms, said the company.
Foundation Medicine chief medical officer Mia Levy said: “As the first group therapy approval for any comprehensive genomic profiling test, this milestone reinforces our dedication to pioneering advances that expand the power of genomic testing in cancer care.
“This approval will allow oncologists to uncover all possible FDA-approved treatment options for these indications through just one test, providing more insights for physicians and patients, more efficiently than ever before.”
Melanoma is a severe form of skin cancer, with BRAF as most common type of mutations.
The CDx test is expected to support oncologists in selecting appropriate BRAF-mutation targeting therapy for their melanoma patients.
According to the company, FoundationOne CDx the only comprehensive genomic profiling (CGP) test to receive FDA approval as a CDx across the two groups of therapies.
FoundationOne CDx will be initially used to identify eligible patients for new therapeutics BRAFTOVI/MEKTOVI from Pfizer and Tafinlar plus Mekinist combination from Novartis.
Furthermore, the CDx test will be automatically applicable for future BRAF inhibitors, approved by the FDA under the approved groups, said Foundation Medicine.
In October last year, FoundationOne CDx was approved by the FDA as a companion diagnostic to identify NTRK gene fusion-positive patients for treatment with Vitrakvi.