07/16/2024 | News release | Archived content
NOW FDA APPROVED: OUR NEWEST* COMPANION DIAGNOSTIC INDICATIONS
Below are the newest* additions to our roster of companion diagnostic approvals across multiple cancers and our portfolio of FDA-approved comprehensive genomic profiling tests. Check back frequently, as new companion diagnostic indications continue to be added.
FoundationOne®CDx and FoundationOne®Liquid CDx: Recent Companion Diagnostic Approvals*
*Includes companion diagnostics approved within the last six months, organized by approval date, then alphabetically within each cancer type and FDA-approved therapy. A complete list of CDx approvals for both FoundationOne CDx and FoundationOne Liquid CDx is below.
TURNING THE VISION OF PRECISION MEDICINE INTO REALITY THROUGH THE POWER OF COMPANION DIAGNOSTICS
When oncologists are treating advanced cancer patients, they need to move quickly from insight to action. To do so, they need comprehensive, reliable information about what is driving a patient's cancer so they can make personalized treatment decisions. We've forged a path forward to achieve the highest quality standards for our tests - to both improve adoption of comprehensive genomic profiling (CGP) and access to this technology in the clinic.
CGP helps inform decisions on available treatment options, including targeted therapies, immunotherapies, tumor-agnostic treatments and clinical trial participation, based on the unique genomic profile of a patient's tumor. Contrary to smaller panels like hotspot or single gene tests, CGP tests deliver comprehensive information in a single test and can provide reliable information on complex genomic signatures. Foundation Medicine's full portfolio of CGP tests and its molecular insights platform are helping improve day-to-day care for cancer patients by providing information on:
Companion diagnostics allow physicians to identify patients who may benefit from FDA approved treatment options. And, as the number of targeted oncology therapy indications and approvals in oncology grow rapidly, companion diagnostics provide information that is critical for the safe and effective use of targeted therapies.
FoundationOne CDx and FoundationOne Liquid CDx have been approved with several companion diagnostic claims and will serve as platforms for further companion diagnostic development, meaning that through supplemental Premarket Approval Applications (PMAs), companion diagnostic claims for additional FDA approved therapies and immunotherapies can be added.
Read on to learn more about Foundation Medicine's tests and the important role that CGP and companion diagnostics play in precision cancer care.
COMPANION DIAGNOSTICS 101
What is a companion diagnostic?
How do comprehensive genomic tests and companion diagnostics help inform cancer care?
Why is FDA approval of diagnostic tests important?
Why is a broad approach to genomic testing needed?
Do Foundation Medicine's tests identify mutations that do not have an associated companion diagnostic?
What is the difference between FoundationMedicine's platform tests, FoundationOne®CDx and FoundationOne®Liquid CDx?
Foundation Medicine is committed to providing oncologists with the tools that they need to make treatment decisions for their patients. We recognize that every patient's situation is unique, and that there are varied scenarios where one of our tests will make more sense than the other. For example, if tumor tissue is readily available, tissue testing may be the most appropriate means of genomic sequencing. But for another patient who may be too sick to undergo another surgery in order to acquire tissue, the option for liquid biopsy could make more sense.
With two FDA-approved tests that both detect over 300 cancer-related genes, we can provide doctors with options to consider when electing to prescribe comprehensive genomic testing. Both tests allow physicians to uncover deep genomic data that can help inform treatment decisions - whether it be through tissue or blood-based biopsies.
ADDITIONAL RESOURCES - LEARN MORE:
FULL LIST OF FDA-APPROVED COMPANION DIAGNOSTICS FOR FOUNDATIONONE® CDX AND FOUNDATIONONE®LIQUID CDX
FoundationOne®CDx is a tissue-based comprehensive genomic profiling test with the following FDA-approved companion diagnostic indications, including:[iiii]
FoundationOne®Liquid CDx is a minimally invasive blood-based comprehensive genomic profiling test with the following FDA-approved companion diagnostic indications, including:
About FoundationOne Liquid CDx
FoundationOne®Liquid CDx is for prescription use only and is a qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors. The test analyzes 324 genes utilizing circulating cell-free DNA and is FDA-approved to report short variants in 311 genes and as a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. When considering eligibility for certain therapies for which FoundationOne Liquid CDx is a companion diagnostic, testing of plasma is only appropriate where tumor tissue is not available. Patients who are negative for other companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.
About FoundationOne CDx
FoundationOne®CDx is a qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors and is for prescription use only. The test analyzes 324 genes as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For the complete label, including companion diagnostic indications and important risk information, please visit www.F1CDxLabel.com.