
Foundation Medicine and Natera Launch Full Commercial Launch of FoundationOneTracker Utilizing Signatera for Treatment Response Monitoring
Foundation Medicine, Inc., and Natera, Inc. have jointly announced the wide-scale clinical launch of FoundationOne®Tracker, a personalized tissue-informed circulating tumor DNA (ctDNA) test designed for monitoring cancer patients’ response to therapy. This monitoring solution is now available to all healthcare providers in the United States seeking to personalize their patients’ treatment response monitoring (TRM). In January, the company’s announced the launch for early access use and use in clinical trials.
Moreover, the Centers for Medicare & Medicaid Services (CMS) Palmetto GBA Molecular Diagnostics Program (MolDX) has confirmed, as of June 17, 2023, that FoundationOne Tracker is eligible for coverage for monitoring the response to immune-checkpoint inhibitor (ICI) therapy for qualifying Medicare beneficiaries with all solid tumors.
FoundationOne Tracker is a ctDNA monitoring test that combines genomic information from FoundationOne®CDx, Foundation Medicine’s tissue-based comprehensive genomic profiling test, with personalized assay design and ctDNA analysis provided by Natera’s Signatera® test. The test is administered serially to monitor patients’ response to therapy, assisting physicians in identifying patients who may be resistant to current treatments and require alternative therapies. It can also identify patients who are responding well to therapy and may benefit from dose reduction or therapy discontinuation.
While imaging techniques such as CT scans and MRIs are the conventional methods for monitoring cancer patients’ treatment response, they have limitations depending on the cancer type and prescribed treatment. FoundationOne Tracker, when used alongside imaging, enhances confidence in treatment monitoring and decision-making. Natera’s Signatera test has been found to be able to detect cancer months prior to imaging.
“Tissue-informed ctDNA monitoring is a natural extension of Foundation Medicine’s current genomic testing portfolio, and we believe this new offering will further enable oncologists to make the best possible decisions about their patients’ care through actionable and personalized data,” stated Brian Alexander, M.D., Chief Executive Officer of Foundation Medicine.
Natera’s Chief Executive Officer, Steve Chapman, emphasized the significance of this development for patients, highlighting the partnership with Foundation Medicine and the Medicare coverage decision, which enhances access to Natera’s core technology for personalized immunotherapy monitoring.
Several recent publications have validated the clinical efficacy of FoundationOne Tracker for late-stage monitoring. One study presented at this year’s American Society of Clinical Oncology (ASCO) annual meeting and published in Clinical Cancer Research revealed that FoundationOne Tracker can inform outcomes of maintenance immunotherapy in patients with advanced non-small cell lung cancer. The study evaluated the use of Chemo-immunotherapy (chemoIO), a common first-line treatment for advanced driver-negative non-small cell lung cancer (NSCLC), often followed by maintenance immunotherapy, where there is significant variability in how maintenance therapy is administered. The study researchers used ctDNA monitoring from Signatera in 221 patients with squamous NSCLC receiving chemoIO. They found that ctDNA monitoring helped identify patients at higher risk for disease progression, even in cases where baseline ctDNA was missing, and may assist in selecting personalized maintenance strategies for patients undergoing chemoIO.
Additionally, research from the OMICO-MoST study, featured in Molecular Oncology, demonstrated that as early as four weeks after treatment, a decline in ctDNA was predictive of improved overall survival. In two patients with complete responses, ctDNA clearance, or complete removal of ctDNA, preceded any scan-based response, providing potential advantages in the use of ctDNA for response assessment.