April 1st, 2019

Resolution Liquid Biopsy Assay Outperforms Guardant360 in Retrospective Non-small Cell Lung Carcinoma Comparison Pilot Study

Scientists from Dana-Farber Cancer Institute present results demonstrating detection of more actionable oncogenic fusions today at AACR Annual Meeting

— Resolution Bioscience, Inc. today announced that scientists from Dana-Farber Cancer Institute are presenting the results of a retrospective liquid biopsy comparison study between Resolution’s ctDx-Lung assay and Guardant Health’s Guardant360® test this morning at the American Association for Cancer Research (AACR) Annual Meeting.

Liquid biopsy assays have the potential to expand access to personalized care for those whose tissue biopsies are inadequate or unavailable and may present an opportunity for enhanced cancer monitoring and detection of minimal residual disease. The study was conducted to explore the technical differences and test the reliability of cell-free DNA next-generation sequencing (NGS) assays, which are not completely characterized at this time.

The comparison study highlights detection challenges of complex mutations such as gene fusions, as well as the need for platform cross-comparisons to realize the potential of liquid biopsy and increase access to personalized cancer care. A cohort of 169 non-small cell lung cancer (NSCLC) patients with Guardant360 results were screened for gene fusions. The team of scientists at Dana-Farber used a soon-to-be-released ctDx-Lung kit to analyze 16 cases that had a rearrangement in their tumor, along with additional banked plasma. All personnel involved in sample analysis were blinded to tumor genotype and Guardant360 results. The team found that the Resolution ctDx-Lung assay identified more actionable gene fusion mutations with higher allele frequencies than the Guardant360 test. The results further demonstrate the potential of the ctDx-Lung kit for patients with advanced NSCLC.

The ctDx-lung kit detected 13 out 16 fusions (allele frequency range 80-0.3%), while Guardant360 detected only seven (allele frequency range 10-0.3%). Of the 13 cases where an oncogenic fusion was detected in plasma, 89% of patients with productive fusions and 75% of patients with ‘non-productive’ fusions responded to tyrosine kinase inhibitor (TKI) therapies. Additional unblinding is ongoing to better understand false negative cases.

“This study is another strong validation of our targeted NGS-based liquid biopsy platform and its ability to outperform other assays, such as the Guardant360 test,” said Mark Li, CEO of Resolution Bioscience. “These results prove our kits can be run at the leading cancer centers around the world, enabling more scientists to detect more of these actionable mutations, which will soon transform the way we diagnose, treat and monitor devastating diseases like NSCLC.”

Attendees interested in the presentation, “Building an effective concordance study: Plasma Next Generation Sequencing (NGS) for oncogenic fusion detection in non-small cell lung carcinoma (NSCLC),” by Cloud Paweletz, PhD, of the Belfer Center at Dana-Farber Cancer Institute can reference abstract 1374/13. The study is being presented today between 8 AM-12 PM in Section 19 of the Georgia World Congress Center Exhibit Hall.

The funding for the study was provided by the Expect Miracles Foundation, the Robert and Renee Belfer Foundation, the Damon Runyon Cancer Research Foundation, and the Harold and Gail Kirstein Lung Cancer Research Fund.

About Resolution ctDx-Lung™
ctDx-Lung is built on Resolution’s patented cell-free DNA NGS analysis platform. The liquid biopsy assay captures and analyzes circulating tumor DNA (ctDNA) for driver mutations in 20 genes associated with NSCLC using Resolution’s proprietary targeted capture NGS chemistry and cloud-based bioinformatics.

About Resolution Bioscience
Resolution Bioscience is a profitable, privately held company dedicated to developing a highly sensitive, non-invasive liquid biopsy platform that improves cancer diagnostics and monitoring for patients around the world. The company has developed and patented core technology for circulating cell-free DNA NGS analysis and was the first to demonstrate identification of all four major types of mutations in a blinded, clinical study. The company is based in Kirkland, WA. For more information, visit www.resolutionbio.com

Resolution Bioscience, the Resolution Bioscience logo, and ctDx-Lung are trademarks of Resolution Bioscience, Inc. All other brands may be trademarks of their respective holders.