NEW YORK – Molecular testing company Predicine said on Tuesday that its blood and urine cell-free DNA (cfDNA) assay, PredicineCare, has secured a CE-IVD mark.
The targeted next-generation sequencing (NGS) assay is developed to detect single nucleotide variants (SNVs), insertions and deletions (indels), DNA rearrangements (fusions), and copy number variations (CNVs) in patients diagnosed with cancer, according to the Hayward, California-based company.
Predicine said that the liquid biopsy-based PredicineCare can target 152 genes, including guideline-recommended gene targets that are known to be actionable and linked to available therapies or clinical trials.
With this CE-IVD mark, Predicine said it plans to commercialize PredicineCare in Europe as an in vitro diagnostic (IVD) test.
"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 CEO, in a statement.