Predicine Receives CE-IVD Mark for Its PredicineCare Assay

Predicine has received a CE-IVD mark for its PredicineCare cell-free DNA assay for genomic profiling in blood and urine.

The liquid biopsy assay targets 152 genes and can detect single nucleotide variants, insertions and deletions, DNA re-arrangements and copy number variations in patients diagnosed with cancer.

Cell-free DNA (cfDNA) are short fragments of DNA released into the bloodstream or urine through the natural process of cell death.

The PredicineCare assay is the first urine-based cfDNA assay that offers “exceptional analytical performance,” the Hayward, Calif. company claims.