20 June 2019 - - US-based liquid biopsy platform developer Resolution Bioscience, Inc has published a blinded performance evaluation between two cell-free DNA (cfDNA) next-generation sequencing assays, the company said.
The publication reports that the team of scientists, led by lung cancer researchers and clinicians at Dana-Farber Cancer Institute, found that the Resolution ctDx-Lung assay identified more actionable gene fusion mutations than Guardant Health's Guardant360 test.
The peer-reviewed manuscript, "Sensitivity of next-generation sequencing assays detecting oncogenic fusions in plasma cell-free DNA," was released online ahead of publication in Lung Cancer.
Plasma genotyping has shown the ability to identify actionable, targetable mutations to drive personalized therapy for patients with advanced non-small cell lung cancer (NSCLC).
However, leading commercial platforms have generated variable results when detecting complex variations, such as oncogenic gene fusions or copy number variations. In this comparison study, a cohort of 169 NSCLC patients with Guardant360 plasma results was screened for the presence of gene fusions based on previous tumor tissue analysis.
Scientists at Dana-Farber used the Resolution kit in their lab to analyze the plasma of 16 patients who had a rearrangement in their tumor. All personnel involved in sample analysis were blinded to tumor genotype and Guardant360 results.
The Resolution assay detected 13 out of 16 (81.3%) fusions (allele frequency range 0.17-62.8%), while the Guardant360 test detected only seven (43.8%) fusions (allele frequency range 0.3-8.2%).
For cases detected by both assays, the Resolution technology identified the mutation at a median of 7% higher allele frequency, which is indicative of a higher capture rate of breakpoint bearing cfDNA that increases overall sensitivity.
For the six patients in which a fusion was detected by the Resolution assay but not by Guardant360, the average time to treatment discontinuation was 15.2 months (full range of 3-34 months).
Dana-Farber scientists hypothesized that the Resolution assay offers more efficient hybridization to cfDNA fragments due to its use of tiled, short (˜40 nt) capture probes rather than more common 120 nt probes.
The Resolution liquid biopsy assays are powered by the company's patented cfDNA NGS analysis platform, which includes proprietary targeted capture NGS chemistry and tightly coupled, cloud-based bioinformatics.
Resolution's technology has now been recognized as novel by the US Food and Drug Administration and has been cited in several important research publications and presentations.
Resolution Bioscience is a privately held company focused on 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.