Foundation Medicine receives FDA approval for pan-tumour biopsy test

27 August 2020 (Last Updated August 27th, 2020 12:52)

Foundation Medicine has received the US Food and Drug Administration (FDA) approval for its pan-tumour liquid biopsy test FoundationOne Liquid CDx.

Foundation Medicine receives FDA approval for pan-tumour biopsy test
FoundationOne Liquid CDx uses blood samples to analyses approximately 300 cancer-related genes for alterations. Credit: Bokskapet / Pixabay.

Foundation Medicine has received the US Food and Drug Administration (FDA) approval for its pan-tumour liquid biopsy test FoundationOne Liquid CDx.

FoundationOne Liquid CDx assay uses blood samples to analyse approximately 300 cancer-related genes for alterations.

The test is a companion diagnostic to detect patients who may benefit from treatment with the four FDA-approved targeted therapies, including indication for Rubraca.

It also acts as a genomic profiling test that reports genomic alteration results and single-gene alterations, including all NTRK fusions, for patients with any solid tumour as an aid in patient care.

According to the company, the test will enable accelerated companion diagnostic development of biopharma companies, developing precision therapeutics.

The FDA approval of FoundationOne Liquid CDx follows the company’s analytical and clinical validation studies that included over 7,500 samples and 30,000 unique variants in 30 cancer types.

Foundation Medicine chief medical officer Brian Alexander said: “We believe that cancer patients and their physicians deserve the highest quality genomic testing to make informed decisions about personalised treatment.

“Created from our scientific expertise and pioneering spirit, FoundationOne Liquid CDx underscores our commitment to advance patient care across all cancer types by bringing forward multiple FDA-approved comprehensive genomic profiling options that are increasingly essential for high-quality cancer care.”

FoundationOne Liquid CDx is set for immediate commercial launch and is covered across all solid tumours for eligible Medicare and Medicare Advantage beneficiaries.

In 2018, Foundation Medicine launched FoundationOneCDx test to identify genomic alterations in 324 genes that are associated with cancer growth.

In the same year, the company launched a liquid biopsy test for solid tumours for commercial use in the US.