Liquid Biopsy Assay Being Utilized in Zejula Trials for PC

Liquid Biopsy Assay Being Utilized in Zejula Trials for PC
A liquid biopsy assay called Resolution HRD is being used in Phase 2 and Phase 3 trials of Zejula (niraparib) to help screen key mutations in prostate cancer patients. Through a blood draw, Resolution Bioscience’s cell-free DNA (cfDNA) assay identifies mutations implicated in homologous recombination deficiency (HRD), which can be single nucleotide variants — changes in only one of the building blocks of DNA — copy number variants, or DNA deletions. HRD refers to defects in a DNA repair pathway. In May, the assay received breakthrough device designation by the U.S. Food and Drug Administration. According to Resolution, the method, being developed as part of a research collaboration with Janssen Research & Development, may benefit patients with late-stage prostate cancer, when tissue can be difficult to collect. Ultimately, it may enable more men to be treated with targeted medicines, such as Zejula. “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 [Zejula],” Mark Li, Resolution’s CEO, said in a press release. Li further noted that the company’s collaboration with Janssen is part of a commitment “to develop diagnostic assays that may assist i
Subscribe or to access all post and page content.