Foundation Medicine recently announced that the US Food and Drug Administration (FDA) approved FoundationOne Liquid CDx to serve as a companion diagnostic for identifying metastatic colorectal cancer patients with BRAF V600E alterations, suitable for treatment with Pfizer’s Braftovi (encorafenib) with cetuximab.
FoundationOne Liquid CDx is a comprehensive pan-tumor liquid biopsy test.
Cetuximab, an anti-epidermal growth factor receptor (anti-EGFR) antibody with FDA approval for metastatic colorectal cancer, is effective in conjunction with encorafenib.
This FDA approval makes personalized medicine more expedient and accessible to a subgroup of patients battling metastatic colorectal cancer associated with a poor prognosis. It also enhances Foundation Medicine’s standing as an innovator in molecular profiling for cancer.
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Colorectal Cancer, Combination Therapy and Companion Diagnostics
Colorectal cancer is the third most frequently diagnosed cancer and the third leading cause of cancer-related death in the US. Approximately 20 percent of new colorectal cancer diagnoses are metastatic at presentation, and an additional 25 percent of patients with initially localized disease will later develop metastases.
Roughly 8 to 12 percent of patients with advanced colorectal cancer present with BRAF alterations, particularly the V600E mutation. The BRAF mutation is a poor prognosis indicator, and optimizing treatment for this patient subgroup is a crucial objective. Pfizer’s encorafenib, a kinase inhibitor that targets BRAF V600E, used in conjunction with cetuximab is the only FDA-approved combination therapy against metastatic colorectal cancer with BRAF V600 mutation.
With this FDA approval of FoundationOne Liquid CDx, physicians can access a cancer mutation profile more quickly and easily. A blood draw is less expensive than a surgical procedure, which expedites the entire treatment process.
“Companion diagnostics are high-quality, well-validated genomic tests that provide critical information to help oncologists make informed treatment decisions for their patients,” said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. “This new companion diagnostic indication for FoundationOne Liquid CDx provides oncologists with an important, non-invasive genomic testing option for metastatic patients with this difficult-to-treat condition.”
What is FoundationOne Liquid CDx?
FoundationOne Liquid CDx is a liquid biopsy test that examines over 300 cancer-related genes for abnormalities using targeted high throughput hybridization-based capture technology. The test utilizes circulating cell-free DNA (cfDNA) isolated from plasma derived from the anti-coagulated peripheral whole blood of advanced cancer patients. It also provides insights about blood tumor mutational burden, microsatellite instability and tumor fraction values, which the FDA has not reviewed or approved.
FoundationOne Liquid CDx has been approved for use as a companion diagnostic for certain FDA-approved precision therapies for non-small cell lung cancer, prostate cancer, ovarian cancer and breast cancer.
A negative result from a plasma specimen does not rule out genomic findings in a patient’s tumor. In such instances, referring to routine biopsy and confirming the tumor mutation status using an FDA-approved tumor tissue test is recommended, if feasible.
Market Trends for Companion Diagnostics
The market for companion diagnostic tests, which provide essential clinical information that helps physicians make informed decisions about developing and using potential drug therapy, has shown strong growth recently. The global companion diagnostics market was valued at $6.8 billion in 2021 and is projected to grow from $7.67 billion in 2022 to $15.91 billion by 2029, reflecting an impressive compound annual growth rate (CAGR) of 11 percent.
Cancer-related diagnostic tests dominate the market, and the rising incidence of cancer fuels the market growth. Additionally, advancements in genetic testing and the development of personalized medicine therapies have driven market growth. Geographically, North America holds the major share of the market, which can be attributed to the presence of many leading companion diagnostics vendors, national clinical laboratories and the developed healthcare system in the US and Canada.