Predicine, a global molecular insights company, has launched its CE-marked PredicineCARE for genomic profiling in blood and urine. The PredicineCARE cell free DNA (cfDNA) assay is a targeted Next-Generation Sequencing (NGS) assay for the detection of single nucleotide variants (SNVs), insertions and deletions (Indels), DNA re-arrangements (fusions) and copy number variations (CNVs) in patients diagnosed with cancer.

Predi is a comprehensive CLIA-certified liquid biopsy assay that targets 152 genes, including guideline recommended gene targets that are known to be actionable and linked to available therapies or clinical trials. PredicineCARE has been utilized by leading biopharmaceutical companies and key opinion leaders (KOLs) in global clinical trials, patient testing and the development of companion diagnostics (CDx).

With this CE mark, Predicine can provide PredicineCARE as a commercialized in vitro diagnostic (IVD) in the European market. PredicineCARE is the first urine-based cfDNA assay that is characterized by exceptional analytical performance and thus will provide great value to patients in Europe.

“Launching PredicineCARE as the first CE-IVD marked product is a significant milestone and aligns with the organization’s strategy to provide affordable and accessible molecular testing solution in the European Market,” said Shidong Jia, Predicine’s Founder and Global CEO.

Predicine will be attending the 2022 European Society for Medical Oncology (ESMO) conference (booth #454) in Paris, France from September 9th to September 13th to present 4 abstracts and other key data on the company’s liquid biopsy portfolio.

Source: Company Press Release