The cell-free DNA assay is currently being used to screen patients with prostate cancer in Phase II and III clinical trials. Credit: Mads Ryø Jochumsen, Bjørn Agerbo Sahlholdt and Jørgen Bjerggaard Jensen.

Resolution Bioscience has collaborated with Janssen Research & Development to develop the Resolution HRD liquid biopsy assay as a companion diagnostic for PARP inhibitor, niraparib.

Niraparib is currently being investigated to treat patients with metastatic castration-resistant prostate cancer (mCRPC).

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The cell-free DNA (cfDNA) assay is capable of identifying homologous recombination deficiency (HRD) mutations and gene deletions. It is currently being used to screen patients with prostate cancer in Phase II and III clinical trials of the PARP inhibitor.

Recently, the Resolution HRD assay secured Breakthrough Device Designation from the US Food and Drug Administration and has the potential to benefit late-stage prostate cancer patients.

The liquid biopsy test can detect sequence variations in key genes related to HRD for single nucleotide variants, copy number variants, and deletions by collecting a simple blood sample.

Resolution Bioscience CEO Mark Li said: “Resolution Bioscience is committed to partnering with leading pharmaceutical companies to develop diagnostic assays that may assist in bringing new therapies to market.

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“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 test. If approved, it could be the first test to detect gene deletions from cfDNA.

Furthermore, the biopsy test can detect biallelic loss of function through the combination of a deleterious mutation and a heterozygous deletion in the same gene and homozygous deletions.

Resolution’s highly sensitive, non-invasive liquid biopsy platform improves cancer diagnostics and monitoring for patients worldwide.