Predicine, Inc., a leading molecular insights company, announced the submission of the first module of its premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for PredicineCARE urine cfDNA NGS assay, as a companion diagnostic (CDx) for patients with bladder cancer.
The first module encompasses comprehensive documentation of Predicine’s manufacturing and quality management systems. This foundational submission is designed to support CDx development of future indications for Predicine’s liquid biopsy and tissue-based assays.
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Subsequent modules for the PredicineCARE bladder cancer indication will be submitted in phases following completion of the registrational trial, in alignment with regulatory requirements.
“This milestone demonstrates Predicine’s capabilities to develop companion diagnostics on the foundation of an FDA-grade quality and manufacturing system,” said Dr. Shidong Jia, Founder and CEO of Predicine. “It reflects our team’s expertise and commitment to bringing innovative, non-invasive testing solutions to patients and physicians worldwide.”
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PredicineCARE received Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration on August 23, 2022. PredicineCARE is a comprehensive, state-of-the-art NGS assay that interrogates point mutations/indels, fusions, amplifications, and deletions in key cancer-associated genes using DNA in tissue, blood and urine samples.
About PredicineCARE Urine cfDNA Assay
The PredicineCARE Urine cfDNA assay is a targeted NGS test that enables detection of genomic alterations, including single nucleotide variants (SNVs), insertions and deletions (Indel), fusions, and copy number variations in urine cfDNA. It is a capture-based assay, which is specifically designed to detect genomic alterations of key cancer relevant genes from blood and urine cfDNA.
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