Data to be presented at the 45th Annual San Antonio Breast Cancer Symposium suggest that the novel sequencing test can detect signs of disease recurrence across breast cancer subtypes, improving outcomes.
NeoGenomics, Inc and their liquid biopsy-focused subsidiary, Inivata Limited, announced that new data support the RaDaR Assay as a test for early breast cancer in the adjuvant and surveillance settings. Data will be presented at the 45th Annual San Antonio Breast Cancer Symposium (SABCS).
The c-TRAK TN trial, which will be presented at SABCS, showed that RaDaR first detected more than 10 times the amount of circulating tumor DNA (ctDNA) than digital PCR testing. Further, time to relapse was longer in patients who were surveyed with RaDaR.
The collective data “adds to the growing body of evidence demonstrating the accuracy of RaDaR in detecting minimal residual disease and early disease relapse," said Vishal Sikri, MBA, president, and chief commercial officer, Inivata, and president, Pharma Services, NeoGenomics, in a press release.
Cancer treatment or surgery may not eradicate all ctDNA from the body. But RaDaR, a personalized and highly selective sequencing test, was created to detect the minimal residual disease (MRD) and recurrence that can occur in patients. The c-TRAK TN trial compared RaDaR to dPCR in patients with early-stage triple-negative breast cancer (TNBC).
More than half of all ctDNA-positive patients with TNBC were first detected using RaDaR compared to dPCR (55.2% and 5.2%), and the lead time between detection and relapse was 1.4 months longer in patients tested with RaDaR (average 7.1 months and 5.7 months). The trial will be used as a spotlight poster presentation and will be presented on December 7.
A second study (TRACER) supporting RaDaR surveillance testing will be presented at SABCS. Prior to neoadjuvant therapy, RaDaR detected ctDNA in 88% of patients (38/43) and allowed for ctDNA dynamics monitoring during treatment, surgical periods, and after therapy.
RaDaR was effective for patients in neoadjuvant therapy, in whom most of their ctDNA levels quickly declined from baseline to cycles 4 or 5. Among 18 patients undergoing surgery, 94% were clear of ctDNA during the surgical period and 96% of post-surgical samples had no trace of ctDNA.
"Our research shows that the RaDaR Assay is able to help follow therapy response in the neoadjuvant setting as well as identify patients at high risk of recurrence,” said David Cescon, MD, PhD, medical oncologist and clinical scientist in the division of Medical Oncology & Hematology, Department of Medicine, Princess Margaret Cancer Centre and University of Toronto, in a press release.
The data from these clinical trials will “create opportunities to use RaDaR in interventional trials and develop new strategies to improve patient outcomes," Cescon explained.
RaDaR can detect up to 48 tumor-specific variants of cell-free DNA in a patient’s blood plasma. This personalized and sensitive technology can detect MRD in patients’ post-treatment (curative intent or definitive) and early signs of relapse.
The RaDaR Assay is approved for clinical use in lung, head and neck, and breast cancers, and the FDA granted it Breakthrough Device Designation.
"We believe RaDaR offers great promise in breast cancer care as the detection of MRD and recurrence provides critical insights that can significantly impact patient care," Sikri said.
NeoGenomics, Inc. RaDaR(R) Assay Demonstrates Clinical Potential for Detecting Disease Recurrence Across All Types of Early Breast Cancer, Including Triple Negative Disease. News Release. December 7, 2022.