FoundationOne Tracker, an assay developed by Foundation Medicine leveraging artificial intelligence with ctDNA detection in plasma has been granted a breakthrough device designation from the U.S. Food and Drug Administration (FDA) for the detection of molecular residual disease (MRD) in early-stage cancer after curative therapy.

The test is the result of a collaboration between Foundation Medicine and Natera launched in September 2019 which has exploited the two companies’ flagship testing assays FoundationOne from Foundation Medicine and Signatera from Natera. The combination leverages Foundation’s strength in comprehensive genomic profiling (CGP) development with Natera’s proprietary ctDNA analysis technology. FoundationOne Tracker was first introduced for research use only in June last year.

“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 in a press release. “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.”

In addition to the indications granted through the Breakthrough Device designation, the companies will continue their development efforts of the personalized assay to expand its use for ctDNA detection and molecular monitoring in patients with both early- and advanced-stage cancers. This will include assessing a patient’s response to therapy, as well as MRD detection, surveillance, and detection of molecular residual relapse following curative intent therapy.

Last month at the ASCO Gastrointestinal Cancer Symposium, Natera presented new data on the use of its personalized and tumor-informed molecular residual disease (MRD) test Signatera, which included an updated analysis from the landmark CIRCULATE-Japan trial analyzing a cohort of colorectal cancer (CRC) patients.

Data presented from the 3,000 patient cohort of CIRCULATE-Japan showed that:

• Signatera positivity is predictive of treatment benefit: patients who were MRD-positive at four weeks post-op benefited significantly from adjuvant chemotherapy (ACT), across all stages of disease.
• Signatera-negative patients did not benefit from ACT: patients with high-risk stage II and stage III disease who were MRD-negative at 4 weeks post-op did not derive significant benefit from ACT (p-value of .63).
• Signatera dynamics during ACT is predictive of treatment benefit: 68% of ACT-treated patients cumulatively cleared their ctDNA by week 24 and had significantly better outcomes relative to those who remained ctDNA-positive, with a hazard ratio of 15.8.

Results also showed that the single time point post-surgical sensitivity of Signatera in stage II and III CRC was 67.6%. This sensitivity analysis included over five times more cancer recurrences than reported in a previous study.

“Current guidelines recommend combination chemotherapy for all patients with stage III CRC, yet it is known that up to 40% are cured by surgery alone. Our study demonstrates that MRD testing can help stratify and predict which patients are likely to benefit from systemic therapy,” said Alexey Aleshin, VP of oncology medical affairs at Natera. “We are extremely pleased with these groundbreaking results from CIRCULATE-Japan and are optimistic they may change practice guidelines.”

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.