On February 15, 2022 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, reported that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device designation for its circulating tumor DNA (ctDNA) detection and molecular monitoring assay, FoundationOneTracker (Press release, Foundation Medicine, FEB 15, 2022, View Source [SID1234608146]). The assay uses optimized algorithms for identifying patient-specific variants and a personalized assay design that allows for the detection of ctDNA in plasma. The Breakthrough Device designation was granted for the assay’s use in the detection of molecular residual disease, commonly known as MRD, in early-stage cancer after curative therapy. This molecular detection can help guide further therapy decisions depending on MRD status and an individual’s risk of relapse.
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Developed in partnership with Natera, FoundationOne Tracker uniquely combines Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) platform with Natera’s expertise in personalized ctDNA monitoring. The companies launched the research use only version of FoundationOne Tracker in June 2021, collaborating to support biopharma and academic partners with clinical trial and companion diagnostic planning.
In addition to the indications granted through the Breakthrough Device designation, FoundationOne Tracker’s personalized technology aims to address ctDNA detection and molecular monitoring in patients with both early- and advanced-stage cancers, including assessment of a patient’s response to therapy, as well as MRD detection, 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, M.D., M.P.H., 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."
The FDA’s Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health.
On the heels of data presented at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancer Symposium last month exploring the feasibility of MRD in metastatic colorectal patients who have undergone curative intent surgical resection, Foundation Medicine will also be presenting additional MRD data at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium on February 18 on the genomics of resected early-stage bladder cancer to validate CGP-informed MRD detection in ctDNA.