FDA Grants Breakthrough Device Designation to ctDNA Monitoring Assay for Early-Stage Cancer

The FoundationOne Tracker ctDNA monitoring assay was given breakthrough device designation by the FDA for use in early-stage cancer after curative therapy.

The FDA has granted breakthrough device designation to the FoundationOne Tracker, a circulation tumor DNA (ctDNA) detection and monitoring assay for patients with early-stage cancer following curative therapy, according to a press release from developer Foundation Medicine.1

The assay was designed to detect molecular residual disease (MRD) and can help to determine future therapy decisions depending on a patients MRD status and risk of relapse.

“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. 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,” Brian Alexander, MD, MPH, chief executive officer at Foundation Medicine, said in a press release.

Foundation Medicine partnered with Natera to combine a comprehensive genomic profiling platform with ctDNA monitoring. During the 2022 American Society of Clinical Oncology Gastrointestinal Cancers Symposium, data from the PREDATOR study were presented in which FoundationOne Tracker was used to MRD status in patients with colorectal cancer (CRC) who had undergone curative intent surgical resection.2

Ttissue-based comprehensive genomic profiling to detect post-operative MRD appeared to be a strong prognostic marker and correlated with disease-free survival (DFS) and overall survival (OS) for patients with metastatic CRC.

Patients were divided into either the ctDNA analysis at post-surgical timepoint 1 (n = 69) in which they received preoperative adjuvant chemotherapy (n = 29) or no preoperative therapy (n = 40), or they were in the ctDNA analysis at last or follow-up timepoint 2 (n = 49) and divided into either the postoperative adjuvant chemotherapy group (n = 17) or no postoperative therapy (n = 32). Patients were then divided into ctDNA-positive or ctDNA-negative groups.

In total, 66.7% being male, median age at metastatic diagnosis was 60.1 years. Patients underwent different types of surgery including liver (58%), lung (21.7%), 13% peritoneum (13.0%), or other types of surgery (7.2%). Additionally, 42.0% of patients received presurgical treatment and 39.1% received post-surgical treatment. Progressive disease was seen in 69.6%. Prior to surgery, 33.3% of patients were carcinoembryonic antigen (CEA)–positive, and post-surgery 18.8% were CEA-positive.

At the postsurgical time point, ctDNA-positive patients had a median DFS of 3.2 months (95% CI, 2.1-7.1) and 31.1 months (95% CI, 16.0-Inf[AP1] [HV2] ) in the ctDNA-negative group (HR, 4.97; 95% CI, 2.67-9.24; P <.0001). The median OS in the ctDNA-positive group was 31.6 months (95% CI, 21.3-Inf), and was not reached in the ctDNA-negative group (HR, 27.05; 95% CI, 3.60-203.46; P <.0001).

At the follow-up timepoint, patients who were ctDNA-positive had a median DFS of 7.7 months (95% CI, 3.4-14.3). Median DFS was not reached in the ctDNA-negative arm (HR, 8.78; 95% CI, 3.59-21.49; P <.0001). The median OS for the ctDNA-positive cohort was 33.2 months (95% CI, 21.8-Inf) and was not reached in te ctDNA-negative cohort (HR, 20.06; 95% CI, 2.51-160.25; P <.0001).

Stratification by CEA result was not associated with DFS, although patients who were stratified by ctDNA detection at postsurgical time point did have a significant association with DFS. In CEA-positive patients, the median DFS was 2.2 months (95% CI, 1.2-Inf) for CEA-positive vs 13.4 months (95% CI, 4.0-Inf) for CEA-negative (HR, 1.97; 95% CI, 0.88-4.43; P = .0945). The median DFS in those who were ctDNA-positive was 2.2 months (95% CI, 1.9-5.4) and 21.0 months (95% CI, 16.0-Inf) for those who were ctDNA-negative (HR, 7.95; 95% CI, 2.54-24.89; P <.0001).

Foundation Medicine plans to present additional MRD data at the 2022 Genitourinary Cancers Symposium.


1. Foundation Medicine’s ctDNA monitoring assay, FoundationOne Tracker, granted breakthrough device designation by the U.S. Food and Drug Administration. News Release. Foundation Medicine. February 15, 2022. Accessed February 16, 2022. https://bit.ly/3rThCSj

2. Nimeiri H, Young A, Madison R, et al. Comprehensive genomic profiling (CGP)-informed personalized molecular residual disease (MRD) detection: An exploratory analysis from the PREDATOR study of metastatic colorectal cancer (mCRC) patients undergoing surgical resection. J Clin Oncol. 2022;40(suppl 4):187. doi:10.1200/JCO.2022.40.4_suppl.187