FDA Grants Breakthrough Device Designation to Foundation Medicine’s ctDNA Tracker

Foundation Medicine’s circulating tumor DNA (ctDNA) detection and monitoring assay, FoundationOne Tracker, was granted a Breakthrough Device Designation from the FDA, streamlining the approval and review processes to give patients and providers earlier access to the device.

The FDA granted a Breakthrough Device Designation to Foundation Medicine’s circulating tumor DNA (ctDNA) detection and molecular monitoring assay, the FoundationOne Tracker1.

According to a company statement, the assay is designed to optimize algorithms for the purpose of identifying patient-specific variants and allow for the detection of ctDNA in plasma cells.

The designation was given to Foundation Medicine for the assay’s ability to detect molecular residual disease (MRD) in patients with early-stage cancer after receiving curative therapy. The detection of MRD can help guide providers in making decisions on therapeutic regimens dependent on the patient’s MRD status and risk of relapse.

The assay was developed in partnership with Natera and combines Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) platform with Natera’s personalized ctDNA monitoring experience. The FoundationOne Tracker was launched by the companies in June 2021. Foundation Medicine and Natera will continue to collaborate to support biopharma and their academic partners with clinical trial evaluations and planning for companion diagnostics.

In addition to the Breakthrough Device Designation, the assay’s personalized technology will be used for the detection of ctDNA and molecular monitoring in patients with early- or advanced-stage cancers as well as the assessment of patient therapeutic responses, MRD detection, MRD surveillance, and detection of molecular residual relapse following curative intent therapy.

“Foundation Medicine continues to shape the future of clinical care and research by helping oncologists and our industry partners find the answers they need to bring precision cancer care to patients,” said Brian Alexander, MD, MPH, chief executive officer at Foundation Medicine.

"Personalized molecular disease monitoring enables early detection of ctDNA and can monitor for risk of relapse and track therapy response to help oncologists make personalized treatment plans for their patients. We are enthusiastic about our work to accelerate development of this assay so that it can more quickly impact care decisions in the clinic,” he continued.

The Breakthrough Device Program under the FDA is a voluntary program for medical devices and device-led combination products that enables more effective treatment or diagnosis of diseases or conditions that are considered life-threatening or irreversibly debilitating.

The goal of the program is to accelerate the development, assessment, and review of devices while continuing to preserve the statutory standard for premarket approval and regulatory authorization. This ensures more patients and providers have timely access to the medical devices.

Data presented at the ASCO Gastrointestinal Cancer Symposium in January 2022 demonstrated the feasibility of MRD in patients with metastatic colorectal cancer who have received curative intent surgical resection. In addition, Foundation Medicine said that it will be presenting additional MRD data on the genomics of resected early-stage bladder cancer at the upcoming ASCO Genitourinary Cancers Symposium. The findings will focus on how data can be used to validate detection of MRD in ctDNA utilizing CGP assessments.


Foundation Medicine’s ctDNA Monitoring Assay, FoundationOne®Tracker, Granted Breakthrough Device Designation by U.S. Food and Drug Administration [news release]. Cambridge, MA: Business Wire; February 15, 2022. foundationmedicine.com/press-releases/af7bb7df-2dcf-411f-bc7d-ebb8ab90d788. Accessed February 15, 2022.

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