The urine-based NGS assay received Breakthrough Device Designation in 2022 and targets genomic alterations in cancer-associated genes.
Predicine Inc has submitted the first module of its premarket approval application to the US Food and Drug Administration for PredicineCARE, a urine cell-free DNA next-generation sequencing assay designed as a companion diagnostic for bladder cancer patients.
The initial module includes documentation of Predicine’s manufacturing and quality management systems, establishing a foundation for future companion diagnostic development across the company’s liquid biopsy and tissue-based assay portfolio. Additional modules specific to the bladder cancer indication will be submitted following completion of the registrational trial.
The PredicineCARE urine cfDNA assay is a targeted NGS test that detects genomic alterations including single nucleotide variants, insertions and deletions, fusions, and copy number variations in urine cell-free DNA. The capture-based assay targets genomic alterations in key cancer-relevant genes from blood and urine cfDNA samples.
“This milestone demonstrates Predicine’s capabilities to develop companion diagnostics on the foundation of an FDA-grade quality and manufacturing system,” says Dr Shidong Jia, founder and CEO of Predicine, in a release. “It reflects our team’s expertise and commitment to bringing innovative, non-invasive testing solutions to patients and physicians worldwide.”
Breakthrough Device Status Supports Development
The FDA granted PredicineCARE Breakthrough Device Designation in August 2022. PredicineCARE is described as an NGS assay that interrogates point mutations, indels, fusions, amplifications, and deletions in key cancer-associated genes using DNA from tissue, blood, and urine samples. The modular PMA submission approach allows Predicine to establish its regulatory framework while completing clinical validation studies.
The Hayward, California-based company positions itself as a molecular insights company focused on advancing precision medicine through liquid biopsy and tissue-based genomic testing solutions. The company serves biopharma partners, clinical researchers, and healthcare providers in drug development and treatment optimization applications.
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