CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
April 23, 2024—Pillar Biosciences announced that the FDA has approved the company’s premarket approval supplement application for the OncoReveal CDx pan-cancer solid tumor in vitro diagnostic assay. The panel covers 22 clinically relevant genes in one multiplex reaction and has a fully automatable workflow with a sample-to-report time of as little as 48 hours. Up to 46 clinical samples can be batched on a single MiSeq Dx run.
“We are pleased to have expanded the clinical utility of OncoReveal Dx, which was the first FDA PMA-approved multicancer IVD kit launched in the market,” Gang Song, founder and executive chairman of Pillar Biosciences, said in a press statement. “In partnership with Illumina, our newest IVD offering, OncoReveal CDx, is a pan-cancer solid tumor IVD that will enable critical diagnostic testing to be performed locally in any NGS lab, whether hospital based or a commercial reference laboratory, running an Illumina MiSeq Dx System.”