A companion diagnostic with greater breadth

FDA approves FoundationOne CDx companion diagnostic test for multiple solid tumors

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CAMBRIDGE, Mass.—In a landmark decision, the U.S. Food and Drug Administration (FDA) in December 2017 approved Foundation Medicine’s FoundationOne CDx, the company’s companion diagnostic test for solid tumors. The approval—for what is the first-ever comprehensive companion diagnostic for multiple types of cancer—advances personalized cancer care, as an estimated one in three patients across five common advanced cancers are expected to match with an FDA-approved therapy.
FoundationOne CDx acts as a comprehensive companion diagnostic to identify patients who may benefit from treatment with specific FDA-approved targeted therapies, Foundation Medicine reports. It is also a genomic profiling test that includes genomic biomarkers to target oncology therapies, including immunotherapies. The test is also a tool for physicians to better identify patient opportunities for clinical trial participation, and it is a platform for companion diagnostic development for biopharma companies developing precision therapeutics.
FoundationOne CDx assesses all classes of genomic alterations in 324 genes known to drive cancer growth, providing crucial information to help guide treatment decisions, according to the company. It covers patients with certain types of non-small cell lung cancer (NSCLC), melanoma, colorectal cancer, ovarian cancer and breast cancer, identifying those patients who may benefit from treatment with one of 17 on-label targeted therapies—including 12 therapies currently approved as first-line treatments.
The diagnostic test also reports genomic biomarkers, such as microsatellite instability (MSI) and tumor mutational burden (TMB), which can help inform the use of immunotherapies.
The number of matched on-label therapies indicated on FoundationOne CDx is expected to increase over time as Foundation Medicine and its biopharma partners pursue FDA approval for additional companion diagnostics on the platform. Today, approximately 50 percent of new cancer drugs in development are projected to have a companion biomarker.
“Today we know that many people with cancer do not receive biomarker testing, let alone the comprehensive genomic testing they need to be efficiently matched to the best therapeutic option,” states Andrea Ferris, president and CEO of the LUNGevity Foundation. “This FDA approval means that, in one test, patients can access therapies where companion diagnostics have been established for their cancer while getting a broad tumor profile that can identify the therapies and clinical trials they could most benefit from.”
“Along with the preliminary national coverage determination, this has the potential to democratize next-generation sequencing, lowering the barriers for patients treated in the community to access these biomarker-driven treatments,” adds Ferris.
“Comprehensive genomic profiling is the gateway to precision medicine … and offering potentially improved healthcare coverage,” states Dr. Ankur R. Parikh, medical director of precision medicine for Cancer Treatment Centers of America. “Access to important genomic information is a critical step in being able to offer innovative and targeted treatment options.”
FoundationOne CDx results are delivered in an integrated report that identifies alterations matched to FDA approved therapies; identifies additional alterations in genes known to drive cancer growth; furnishes information about genomic biomarkers, including MSI and TMB; provides relevant clinical trial information; and includes interpretive content.
“Physicians will have an FDA-approved test for all solid tumors in their toolkit that can inform targeted and immunotherapy selection, as well as identify patient opportunities for clinical trial participation,” states Troy Cox, CEO of Foundation Medicine. “Beyond its implications for patient care, we expect that FoundationOne CDx … can help accelerate drug development and enable personalized oncology care.”
FoundationOne CDx is expected to be commercially available following finalization of the NCD from CMS. Currently, companion diagnostics only probe for alterations in a single or small number of genes, which can cost valuable time, require multiple tissue samples and miss potentially actionable information, Foundation Medicine says. FoundationOne CDx has the potential to help streamline the treatment decision process for both oncologist and patient.
Study results presented in October 2017 at the IASLC World Conference on Lung Cancer showed that FoundationOne CDx detected alterations in the EGFR, ALK, BRAF, ERBB2, KRAS and BRCA1/2 genes and demonstrated concordance with FDA-approved companion diagnostics currently used to match targeted therapies to patients with certain types of NSCLC, melanoma, colorectal cancer, ovarian cancer and breast cancer.

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