Foundation Medicine and Natera announced the broad clinical launch of FoundationOne Tracker, a personalized tissue-based circulating tumor DNA (ctDNA) test for monitoring cancer patients’ responses to treatment. This test utilizes genomic information from FoundationOne CDx, which is Foundation Medicine’s comprehensive genomic profiling of tissue, and incorporates Natera’s personalized analytical design and ctDNA analysis.
FoundationOne Tracker is now available to all healthcare providers in the United States for treatment response monitoring (TRM). Additionally, the MolDX program from Palmetto GBA, part of the Centers for Medicare & Medicaid Services (CMS), has determined that FoundationOne Tracker will be used for monitoring responses to immune checkpoint inhibitor (ICI) therapy for all eligible beneficiaries with solid tumors, starting from June 17, 2023.
While imaging techniques such as CT scans and MRIs are the standard of care for monitoring cancer patients’ treatment responses, they have known limitations depending on cancer type and prescribed treatments.
Recent studies conducted by the companies have demonstrated the clinical effectiveness of FoundationOne Tracker in late-stage monitoring. In a study presented at this year’s American Society of Clinical Oncology (ASCO) annual meeting, researchers found that FoundationOne Tracker could provide insights into the outcomes of immune maintenance therapy for late-stage cancer patients in the IMpower131 trial, and this study was recently published in Clinical Cancer Research.
Foundation Medicine and Natera initiated their collaboration as early as 2019, with the initial aim of using Foundation Medicine’s FoundationOne CDx as a baseline test to define a unique set of variants. These variants would then be monitored using jointly developed analytics, including components of Natera’s Signatera platform. The Early Access Program for FoundationOne Tracker had already been launched by the beginning of this year, and in February 2022, FoundationOne Tracker received FDA breakthrough device designation for molecular residual disease detection after early cancer treatment.
Natera is a company in the field of cell-free DNA testing, focusing on oncology, women’s health, and organ health. The company’s goal is to make personalized genetic testing and diagnostics a part of the standard of care for preserving health and providing information for early diagnosis or targeted interventions. Natera’s tests have been validated in over 100 peer-reviewed publications, demonstrating their high accuracy. The company has provided over 3 billion cell-free DNA tests globally.
On the 28th of last month, Natera also submitted a PMA application to the FDA for Signatera, which is a companion diagnostic (CDx) test for patients with muscle-invasive bladder cancer (MIBC). This further underscores Natera’s commitment to advancing tumor diagnostics, treatment monitoring, and minimal residual disease (MRD) assessment.
