FDA Grants Breakthrough Status for New Cancer Tool

Foundation Medicine has won the coveted FDA breakthrough device designation for its circulating tumor DNA (ctDNA) detection and molecular monitoring assay, FoundationOne Tracker.

The Cambridge, MA-based company's new assay is designed with 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, the company noted.

Developed in partnership with Natera, the FoundationOne Tracker combines Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) platform with Natera’s expertise in personalized ctDNA monitoring. The companies launched a research-use-only version of the 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 FDA's breakthrough device designation, the company said the 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, CEO 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.”

On the heels of data presented at the ASCO 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 Genitourinary Cancers Symposium on February 18 on the genomics of resected early-stage bladder cancer to validate CGP-informed MRD detection in ctDNA.