On February 24, 2020 Resolution Bioscience, Inc., reported an agreement with LabCorp (NYSE: LH), a leading global life sciences company that is deeply integrated in guiding patient care, to make the Resolution ctDx Lung assay available to clinicians and patients (Press release, Resolution Bioscience, FEB 24, 2020, View Source [SID1234554691]). The fast, accurate, and non-invasive test is designed to detect actionable mutations in non-small cell lung cancer (NSCLC) genes recommended by professional guidelines. The assay will be performed in Resolution’s CLIA laboratory as a laboratory developed test, and is expected to be available exclusively from LabCorp in the first half of 2020.
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The clinical utility of the Resolution ctDx Lung assay has been successfully demonstrated in multiple clinical studies with leading cancer centers and academic research institutions, including Memorial Sloan Kettering Cancer Center, Northern Cancer Institute of Sydney, Dana-Farber Cancer Institute, and Vanderbilt University.
"We are excited to be working with LabCorp to enable broad access to our ctDx Lung assay," said Mark Li, CEO of Resolution Bioscience. "With our purpose-built cell-free DNA technology platform, we look forward to making a clinically meaningful impact for a growing number of patients."
About Resolution Bioscience’s Liquid Biopsy Technology
The Resolution liquid biopsy assays are powered by the company’s patented cell-free DNA (cfDNA) analysis platform, which includes proprietary targeted capture next-generation sequencing (NGS) biochemistry and tightly coupled, cloud-based bioinformatics. Resolution’s technology has now been recognized as novel by the FDA and has been cited in several important scientific publications and presentations. For example:
97% clinical response was seen for NSCLC patients who received plasma-directed therapy selection from Resolution’s assay as reported in a publication with Memorial Sloan Kettering Cancer Center and the Northern Cancer Institute of Sydney. With more than 1,000 patients enrolled, the ongoing study is the largest prospective study of stage II, III, or IV NSCLC aimed at demonstrating clinical response and outcomes based upon plasma-directed therapy selection.
A recent study by the Dana-Farber Cancer Institute found that the Resolution ctDx Lung assay identified more actionable gene fusion mutations than Guardant Health’s Guardant360 test.
Resolution was the first to demonstrate the detection of all four major types of mutations in a blinded clinical study led by scientists at Dana-Farber Cancer Institute. The team determined the assay has the potential to be implemented broadly for patient care and translational research.
Resolution was also the first company to demonstrate gene deletion detection in cfDNA in a study led by scientists at Vanderbilt University in small cell lung cancer. The team determined that cfDNA sequencing allows for improved monitoring of disease burden, depth of response to treatment, and timely warning of disease relapse in patients.
The Resolution HRD assay was granted Breakthrough Device Designation by the US Food and Drug Administration (FDA).
In a recent AstraZeneca publication, Resolution had the highest positive predictive value and the lowest false positive rate among four leading NGS liquid biopsy companies in a blinded comparison study.