Every patient responds differently to immunotherapy treatment and clinical factors such as duration and dosing vary widely. ctDNA monitoring can inform whether to continue, adapt, or discontinue ineffective treatments which could help patients avoid unnecessary side effects and financial burden.
Is treatment working? ctDNA monitoring brings clarity to treatment response
When treating advanced cancer patients, you need to know if treatment is working.
Circulating tumor DNA (ctDNA) is shed into the bloodstream by a patient's tumor—and acts as a highly sensitive biomarker predictive of treatment response. By measuring change in ctDNA levels during treatment, you and your patients can gain clarity into treatment response and make more informed treatment decisions.
Now you can monitor changes in ctDNA with FoundationOne®Tracker. By providing objective insights, FoundationOne Tracker can complement imaging to help you more accurately monitor and assess treatment response.
What is FoundationOne Tracker?
FoundationOne Tracker is a personalized, tissue-informed ctDNA monitoring test that provides objective insights to help you understand response to treatment for patients with advanced cancer, across all solid tumors.
Designed to be used in a series, FoundationOne Tracker uses a baseline derived from FoundationOne®CDx to provide tissue-informed ctDNA results without the need for an additional tissue test*.
Subsequent customized FoundationOne Tracker tests, powered by Natera’s SignateraTM technology, are then performed, using only a simple blood sample at each timepoint to monitor changes to ctDNA levels.
Patient Access to FoundationOne Tracker:
- Covered by Medicare for monitoring of response to immune-checkpoint inhibitor (ICI) therapy for patients with all solid tumors.
- No out-of-pocket costs for Qualifying Original Medicare beneficiaries.
*Patients who have had FoundationOne CDx test results reported August 20, 2019, or later, do not require an additional tissue test to initiate FoundationOne Tracker ctDNA monitoring.
In a clinical study, ctDNA monitoring using FoundationOne Tracker supported earlier detection of disease progression during immunotherapy 11.5 months sooner than imaging.
FoundationOne Tracker delivers evidence and insights to help:
- Optimize treatment sooner for patients with an existing FoundationOne CDx test result, by accelerating time to first ctDNA monitoring timepoint
- Clarify imaging, or determine true progression vs. pseudo-progression
- Determine when to adjust or discontinue treatment
How To Use FoundationOne Tracker
FoundationOne Tracker can be added to any prior FoundationOne CDx test with results reported August 20, 2019, or later. Alternatively, FoundationOne Tracker can be ordered together with a new FoundationOne CDx test.
FoundationOne Tracker is designed to be ordered at multiple timepoints to monitor response to treatment longitudinally. A simple blood sample at each timepoint is all you need to monitor changes to ctDNA levels.
You should determine how often to order FoundationOne Tracker based on the needs of your patient.
In the peer-reviewed publication that led to Medicare approval for pan-tumor immunotherapy response monitoring, FoundationOne Tracker tests were performed at three timepoints, each 4 weeks apart.
FoundationOne Tracker Resources
Foundation Medicine and Natera Announce Broad Clinical Launch and Medicare Coverage of FoundationOne®Tracker
Foundation Medicine, Inc., and Natera, Inc., today announced the broad clinical launch of FoundationOne®Tracker, a personalized tissue-informed circulating tumor DNA (ctDNA) test to monitor cancer patients’ response to therapy. FoundationOne Tracker is now available to all U.S. healthcare providers for treatment response monitoring (TRM).
Order Foundation One Tracker Specimen Shipping Kits to your practice.
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Important Safety Information
FoundationOne®Tracker is a clinical test performed exclusively as a laboratory service. This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). FoundationOne Tracker is a personalized assay for oncology that is based on patient-specific somatic variants (substitutions and short insertions/deletions) identified from baseline tumor tissue testing and used to detect and longitudinally measure plasma circulating tumor DNA (ctDNA) abundance as a biomarker for tumor burden. Treatment decisions are the responsibility of the treating physician. ctDNA detection sensitivity may be limited if blood collection occurs within two weeks of surgery or while a patient is on therapy. A negative test result does not definitively indicate the absence of cancer. This test is not designed to detect or report germline variation, nor does it infer hereditary cancer risk for a patient. This test is designed to detect ctDNA from the assayed tumor only; new primary tumors will not be detected. This test is expected to have limited sensitivity in some cancer types due to limited ctDNA shed.
FoundationOne®CDx is a qualitative next-generation sequencing based in vitro diagnostic test for 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
FoundationOne Liquid CDX
FoundationOne®Liquid CDx is for prescription use only and is a qualitative next-generation sequencing based in vitro diagnostic test for 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.