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Resolution Bioscience, Janssen Partner to Develop CDx for Niraparib in Prostate Cancer

NEW YORK (GenomeWeb) – Resolution Bioscience said today that it is collaborating with Janssen to develop its Resolution HRD liquid biopsy test as a companion diagnostic for niraparib, a PARP inhibitor being investigated to treat patients with metastatic castration-resistant prostate cancer.

Resolution HRD is a blood-based, cell-free DNA assay that detects single nucleotide variants, copy number variants, and deletions in genes related to homologous recombination deficiency (HRD). The assay is currently being used to screen prostate cancer for HRD mutations and deletions as part of phase II and II clinical studies of niraparib in prostate cancer. Janssen has exclusive worldwide rights from Tesaro to develop niraparib for use in prostate cancer.

Resolution received a Breakthrough Device Designation from the US Food and Drug Administration for Resolution HRD last month.

"Resolution Bioscience is committed to partnering with leading pharmaceutical companies to develop diagnostic assays that may assist in bringing new therapies to market," Resolution Bioscience CEO Mark Li said in a statement. "We expect the Resolution HRD assay will enable Janssen to identify patients with prostate cancer who may benefit from niraparib therapy."

Resolution plans to seek approval for the assay as a companion diagnostic for niraparib in prostate cancer. If approved, the firm said the assay could be the first test to find gene deletions from cfDNA, as well as to distinguish between single copy and homozygous gene deletions through a blood draw.