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First-of-a-Kind Companion Test for Cancer Gene Profiling Gets FDA Approval

Jaime Rosenberg
The FDA has approved Foundation Medicine's FoundationOne CDx, the first-of-a-kind comprehensive companion diagnostic test for solid tumors. The test looks for hundreds of cancer genes, providing healthcare professionals with a more complete picture of what's causing tumor growth and guidance for treatment decisions.
The FDA has approved FoundationOne CDx, the first-of-a-kind comprehensive companion diagnostic test for solid tumors, announced Foundation Medicine.

FoundationOne CDx is the first and only comprehensive genomic profiling test for all solid tumors incorporating multiple companion diagnostics. It works by examining all classes of genomic alterations in the 324 genes known to cause cancer growth, presenting healthcare professionals with a more complete picture of what’s causing tumor growth and potentially actionable information to help direct treatment decisions. According to the statement, the test acts as:
  • A comprehensive companion diagnostic to identify patients who may benefit from treatment with specific FDA-approved targeted therapies
  • A comprehensive genomic profiling (CGP) test that includes genomic biomarkers, such as microsatellite instability and tumor mutation burden, to help inform the use of other targeted oncology therapies, including immunotherapies
  • A tool for physicians that identifies patient opportunities for clinical trial participation
  • An FDA-approved platform for companion diagnostic development for biopharma companies developing precision therapeutics.
"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," said Andrea Ferris, president and CEO, LUNGevity Foundation, in the Foundation Medicine statement. "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."

Based on previous CGP testing by Foundation Medicine, an estimated 1 in 3 patients across 5 common advanced cancers (non-small cell lung cancer, melanoma, colorectal cancer, ovarian cancer, or breast cancer) will likely match with an FDA-approved therapy. The test serves as a companion diagnostic for patients with these types of cancers to identify which patients may benefit from any of 17 on-label targeted therapies, including 12 therapies currently approved as first-line targeted therapies.

In addition to FDA approval, CMS issued a preliminary National Coverage Determination for FoundationOne CDx, which would provide coverage for FDA-approved companion diagnostic claims, as well as a pathway for additional coverage with evidence development in other solid tumor types.

“Today's historic parallel review decision from the FDA and CMS represents a major advancement in personalized cancer care," said Troy Cox, CEO of Foundation Medicine, in the statement. "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.”

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