U.S./Australian Study Highlights Rapid Analysis and Clinical Utility of Liquid Biopsy Assay

KIRKLAND, Wash., Nov. 28, 2018 /PRNewswire/ -- Researchers at Memorial Sloan Kettering Cancer Center (MSK), the University of Sydney and Resolution Bioscience have reported the first prospective clinical study of circulating tumor DNA (ctDNA) using next generation sequencing (NGS) to rapidly guide treatment of lung cancer patients. The research was published by Sabari and colleagues in the Journal of the National Cancer Institute. These results contributed to the New York State Department of Health's approval of ctDx Lung for clinical use.

Assessing patients in New York and Sydney with metastatic non-small cell lung cancer (NSCLC), the study showed Resolution's ctDx Lung assay successfully matched patients with targeted treatments and led to clinical responses. In addition, compared to tissue NGS, the blood-based assay reduced mean turnaround times by half.

"This prospective study is an important validation of our blood-based approach," said Mark Li, president and CEO of Resolution. "Using a non-invasive test, we identified actionable mutations that helped guide treatment. These findings support further efforts to incorporate plasma NGS into standard of care."

Led by MSK-attending medical oncologist Bob T. Li, MD and clinical investigators on two continents, the study enrolled 210 patients with advanced NSCLC, all of whom received the plasma NGS test. In addition to the blood test, 106 of the participants received the MSK-IMPACT tissue biopsy NGS test. Among those who tested positive for cancer-driving mutations by the plasma assay, the results were concordant with MSK-IMPACT in 96 percent of the cases with tissue biopsy results.

Resolution's ctDx Lung detects all four types of somatic mutations: point mutations, indels, gene fusions, and copy number changes. Detected actionable mutations included EGFR point mutations and indels, ERBB2 and BRAF mutations, MET amplification, and ALK, RET, and ROS1 fusions. Among those patients that received a targeted therapy based on the plasma test, 97 percent of evaluable patients showed a clinical and radiologic response to treatment.

Standard blood draw samples were shipped to Resolution's CLIA lab in Redmond, Washington for analysis. Nevertheless, when tracking the time from blood draw to delivery of results to doctors, the ctDNA liquid biopsy took, on average, only nine days, compared to 20 days for the tissue biopsy NGS.

"These findings provide prospective evidence to support the incorporation of plasma NGS into lung cancer practice guidelines," said Bob T. Li, MD, lead investigator of the study. "We are encouraged by these findings as we have demonstrated that plasma NGS genotyping is feasible, rapid, and useful in the real-world clinical practice for this patient population."

"This study is designed to investigate clinical response based upon results generated by our cell-free DNA platform. While still important, it is time to progress the conversation from tissue concordance to clinical utility," added Mark Li. "The fast, clinically-relevant turnaround further adds to the overall utility."

About Resolution Bioscience, Inc.

Resolution has created a proprietary platform to capture and analyze circulating, cell-free DNA. Through noninvasive diagnostic tools, the company seeks to improve care for cancer patients everywhere. Founded in 2012, Resolution is a privately-held next-generation sequencing (NGS) technology company.

SOURCE Resolution Bioscience