Natera has reported that new data from the CIRCULATE-Japan trial shows that its tumour-informed molecular residual disease (MRD) assay, Signatera, can predict the benefit of chemotherapy treatment for colorectal cancer (CRC) patients.

A custom-built circulating tumour DNA (ctDNA) test, Signatera is designed to monitor treatment and analyse MRD in patients diagnosed with cancer.

The US Food and Drug Administration (FDA) granted three breakthrough device designations for the test for various types of cancer and indications.

Available for clinical and research use, Signatera offers each person a customised blood test made to fit the unique signature of clonal mutations seen in a patient’s tumour.

The prospective, multi-centre, MRD-guided CIRCULATE-Japan trial has now recruited more than 3,000 CRC patients.

In this study, the MRD status of patients who are suffering from stage I-IV CRC will be monitored post-surgery for a period of up to 96 weeks using the Signatera test.

The examination of more than 1,000 participants from the study’s observational GALAXY arm highlighted three new findings that were presented at the 2022 Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology.

According to the findings, Signatera showed positivity in predicting the benefits of chemotherapy treatment. MRD-positive patients at four weeks post-operation stood to benefit from adjuvant chemotherapy (ACT) across all stages of cancer.

Patients who were Signatera-negative did not benefit from ACT. The test showed that patients with high-risk stage II and stage III disease who were MRD-negative at four weeks post-operation did not significantly benefit from ACT.

During ACT, Signatera dynamics was predictive of treatment benefit. It was found that 68% of ACT-treated patients had cleared their ctDNA by week 24 and also showed better outcomes as against those who remained ctDNA-positive.

Natera oncology medical affairs vice-president Alexey Aleshin said: “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.

“We are extremely pleased with these groundbreaking results from CIRCULATE-Japan and are optimistic they may change practice guidelines.”

Last October, Natera introduced Prospera lung transplant assessment test for lung transplant recipients.