NEW YORK (360Dx) – Epic Sciences said today that it has received a CE-IVD mark for its liquid biopsy test collection kit, which is compatible with the firms expanding menu of cell-based diagnostic and clinical research assays performed using its "No Cell Left Behind" technology.
The tests can now be marketed and sold in Europe.
The San Diego-based firm's collection kit is designed to stabilize and preserve blood samples for safe shipment to Epic Sciences processing sites, ensuring reliable and accurate analysis. Epic currently markets a clinical AR-V7 test for prostate cancer therapy prediction that is marketed in the US by Genomic Health. Other assays developed for research use include a breast cancer CTC biomarker panel and a morphological method for identifying DNA repair deficiency.
"Receiving CE mark for our Liquid Biopsy Collection Kit marks a significant milestone in our mission to enable global interventional clinical studies," Epic Chief Scientific Officer Pascal Bamford said in a statement. "Further enabling our global reach is a key strategic milestone toward offering all cancer patients the actionable information they need to drive therapeutic decisions," he added.