Company continues to execute on its global strategy to bring highly accurate and sensitive NGS cancer diagnostics to enable localized testing
NATICK, Mass., April 23, 2024 /PRNewswire/ — Pillar Biosciences, Inc., the leader in Decision Medicine™, which develops and distributes next-generation sequencing (NGS) tests to localize testing and reduce time to treatment initiation and testing costs, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Premarket Approval (PMA) supplement application for its oncoReveal™ CDx pan-cancer solid tumor in vitro diagnostic (IVD). The approval expands the indication of oncoReveal™ Dx from EGFR & KRAS therapy selection in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) to now include general solid tumor profiling.
“We are pleased to have expanded the clinical utility of oncoReveal™ Dx, which was the first FDA PMA-approved multi-cancer IVD kit launched in the market,” said Gang Song, Founder and Executive Chairman of …