June 19th, 2019

Resolution Advancing Development of Cell-Free DNA Companion Diagnostic for Prostate Cancer through Collaboration with Janssen

Liquid biopsy assay with recent Breakthrough Device Designation from FDA is being used to screen patients with prostate cancer for HRD mutations and deletions as part of phase II and III clinical studies

— Resolution Bioscience, Inc., today announced that its Resolution HRD™ liquid biopsy assay is being developed as a companion diagnostic for niraparib, a PARP inhibitor that is currently being investigated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) as part of a research collaboration with Janssen Research & Development, LLC (Janssen). The cell-free DNA (cfDNA) assay, which detects homologous recombination deficiency (HRD) mutations and gene deletions, is currently being used in phase II and III clinical studies of niraparib in prostate cancer.

Recently granted Breakthrough Device Designation by the US Food and Drug Administration, the Resolution HRD assay has the potential to benefit late-stage prostate cancer patients when tissue can be difficult to collect. The Resolution liquid biopsy test detects sequence variations in key genes related to HRD for single nucleotide variants, copy number variants, and deletions. The ability to detect these alterations from a simple blood draw has the potential to allow for more men to receive targeted therapies, such as niraparib.

"Resolution Bioscience is committed to partnering with leading pharmaceutical companies to develop diagnostic assays that may assist in bringing new therapies to market," said Mark Li, CEO of Resolution Bioscience. "Built on our proprietary cfDNA next-generation sequencing technology platform, we expect the Resolution HRD assay will enable Janssen to identify patients with prostate cancer who may benefit from niraparib therapy."

Resolution Bioscience plans to seek approval for the Resolution HRD assay as a companion diagnostic for niraparib in prostate cancer. If approved, the Resolution HRD assay could be the first test to detect gene deletions from cfDNA, as well as to differentiate between single copy and biallelic (homozygous) gene deletions through a simple blood draw. The assay is also designed to detect biallelic loss of function through the combination of a deleterious mutation and a heterozygous deletion in the same gene, as well as homozygous deletions.

About Resolution Bioscience
Resolution Bioscience is a 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 Resolution HRD are trademarks of Resolution Bioscience, Inc. All other brands may be trademarks of their respective holders.