May 2024—Pillar Biosciences announced that the FDA has approved the company’s premarket approval supplement application for its 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.
OncoReveal Dx, which is approved for use on the MiSeq Dx for therapy selection for non-small cell lung cancer and colorectal cancer, received premarket approval in July 2021. The test simultaneously detects clinically relevant mutations in EGFR for NSCLC and KRAS for CRC.
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