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
KIRKLAND, Wash.–(BUSINESS WIRE)–#CDx—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 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.
Contacts
Andrew Noble
415-722-2129
andrew@bioscribe.com