On January 9, 2023 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, and Natera, Inc., a global leader in cell-free DNA testing, reported an early access program for clinical use of FoundationOne Tracker, a personalized circulating tumor DNA (ctDNA) monitoring assay (Press release, Foundation Medicine, JAN 9, 2023, View Source [SID1234626135]). In addition, the investigational use only version of the test is now available for use in clinical trials.

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FoundationOne Tracker combines genomic information derived from FoundationOneCDx, Foundation Medicine’s tissue-based comprehensive genomic profiling test, with personalized assay design and ctDNA analysis from Natera. The test offers physicians the ability to serially monitor their patients’ response to treatment, especially immunotherapies, using a simple blood draw, and to use those insights to make informed decisions for future care. FoundationOne Tracker is now available through an early access program to a limited number of clinical customers, with plans to expand for broad availability in the United States later in 2023.

The current imaging-based standard of care for cancer monitoring is not precise or applicable to all cancer types and treatments, which has an impact on patient outcomes.1-4 For example, immunotherapy is used broadly across patients with advanced cancer, yet there remains an unmet need when assessing response to therapy and disease progression. FoundationOne Tracker offers physicians a tissue-informed, efficient and precise tool for treatment response monitoring (TRM) to inform personalized treatment strategies. It can be used as a complementary tool to imaging in order to more accurately assess response to treatment and inform next steps in patient care, particularly in cases when imaging is ambiguous or conflicting.

"We developed FoundationOne Tracker to help physicians identify patients who are resistant to their current treatment and may need additional therapy, or those who are responding well to therapy and may benefit from skipping unnecessary doses," says Foundation Medicine Chief Executive Officer Brian Alexander, M.D., M.P.H. "With this new tool that leverages the molecular fingerprint of the cancer, we hope to maximize the impact of genomic profiling to support a higher degree of personalized cancer care for patients."

The version of FoundationOne Tracker for research use was launched in June 2021 for retrospective analysis of archived specimens, providing a cost-effective and efficient path to bring personalized monitoring tools to Foundation Medicine’s biopharma and academic partners. The investigational use version of the test, which may be used for real-time processing of fresh specimens in ongoing prospective studies, is now available to gain earlier insights on treatment response in clinical studies.

"We are pleased to collaborate with Foundation Medicine and support broader access to cutting-edge tools that enable precision medicine," says Natera’s Chief Executive Officer, Steve Chapman. "This aligns with Natera’s mission to make our personalized monitoring assay technology available to all patients and improve outcomes."

This launch closely follows two publications demonstrating the clinical validity of FoundationOne Tracker’s value in the TRM and molecular residual disease (MRD) settings, respectively. Research published in Molecular Oncology features results from the OMICO-MoST study, the first advanced pan-cancer solid tumor study to demonstrate FoundationOne Tracker’s ctDNA dynamics for treatment response monitoring for two forms of immunotherapy. In another study recently published in the International Journal of Molecular Sciences, researchers established the feasibility of ctDNA-based MRD detection in metastatic colorectal cancer patients undergoing surgical resection. These studies are part of the extensive body of evidence both Foundation Medicine and Natera are generating to support the value of integrating tissue-informed ctDNA monitoring in clinical practice.

In February 2022, FoundationOne Tracker was granted a Breakthrough Device designation from the FDA for the assay’s use in the detection of MRD in early-stage cancer after curative therapy. The commercial launch of FoundationOne Tracker expands Foundation Medicine’s portfolio of molecular tests, which includes FDA-approved blood- and tissue-based CGP testing options and offers physicians a toolkit of options for detecting genomic alterations and tracking treatment response to help guide personalized cancer care.