RESOLUTION BIOSCIENCE INC.

Company Overview

Resolution Bioscience Inc., founded in 2012, is developing and commercializing NGS-based, cfDNA-based platforms for cancer diagnostics and monitoring.

Resolution Bioscience’s Bio ctDx Comprehensive Liquid Biopsy platform captures the cfDNA in a blood sample and then uses NGS to analyze the DNA. The assays are run out of Resolution’s CLIA-certified laboratory. The company is developing kits that can be used by any laboratory to run its assay as part of its European expansion strategy.

Bio ctDx’s differentiating features include its target capture method and bias correction chemistry.

For target capture, the assay uses smaller probes of 40 base pairs compared to standard probes sizes of up to 120 base pairs. A short probe is useful in detecting gene fusions in ctDNA, which has an average length of 165 bases, because shorter probes do not span fusion breakpoints. Unique bias correction chemistry allows the short probes to bind to their target, without being biased by GC content of the target.

Assays offered as LDTs using the ctDx platform include for lung cancer, ALK fusions and resistance, and for profiling individual T cell receptors.

The ctDx lung cancer assay detects single nucleotide variants and more difficult-to-detect variations including insertions and deletions, CNVs, and gene fusions from blood samples. The test examines a small panel of genes that are drivers of targeted therapies and selection of patients for clinical trial eligibility.

In September 2018, Resolution Bioscience’s ctDx lung cancer assay was granted regulatory approval by the New York State Clinical Laboratory Evaluation Program. This certification expanded the market for this assay, as it increases the patient pool and makes clinical studies in New York easier.

In June 2019, Resolution Biosciences formed a partnership with Janssen Research & Development to develop liquid biopsy companion diagnostics for Niraparib, a poly ADP ribose polymerase inhibitor that is designed to treat metastatic castration-resistant prostate cancer. Earlier, this assay received Breakthrough Device Designation from the FDA, and Janssen is using it to identify prostate cancer patients with homologous recombination deficiency (HRD) mutations and gene deletions in Phase I and II clinical studies of niraparib.

Resolution’s HRD liquid biopsy assay detects HRD mutations and gene deletions in cfDNA and distinguishes between single copy and biallelic gene deletions. It also detects homozygous deletions and identifies when deleterious mutations and heterozygous deletions are present in the same gene, a combination that causes biallelic loss of function. If approved, this assay would be the first commercial test to detect all these alterations from a single blood draw.

In February 2020, Resolution Biosciences partnered with LabCorp to commercialize the Resolution ctDx Lung test. This test is a liquid biopsy test that uses NGS to examine actionable mutations in cfDNA from NSCLC patients. LabCorp became the exclusive provider with Resolution in performing the assay as an LTD from its CLIA laboratory. This test was launched commercially in September 2020.

In 2021, Agilent Technologies acquired Resolution Bioscience. This acquisition positioned Agilent Technologies in the NGS-based liquid biopsy market segment.

In September 2023, Agilent Technologies Inc. and Exact Sciences Corp., a leading provider of cancer screening and diagnostic tests, announced they had entered into a definitive agreement for the sale of Resolution Bioscience to Exact Sciences.

Company's Business Segments

• Liquid biopsy Assays : This segment provides Resolution ctDx first, Resolution ctDx lung, and Immuno-oncology.