On July 19, 2022 Pillar Biosciences, the leader in Decision Medicine, which develops and distributes next-generation sequencing (NGS) tests to localize testing and reduce time to treatment initiation and overall testing costs, reported that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Premarket Approval (PMA) supplement application for its Pan-cancer oncoReveal CDx (Press release, Pillar Biosciences, JUL 19, 2022, View Source [SID1234616773]). The supplement, if approved, will expand the label/indication of Pillar Bioscience’s oncoReveal Dx Lung & Colon Cancer Assay to include actionable targets for eight additional cancer types, bringing the total detectable cancers to ten.

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"We are pleased to take the next step towards expanding the clinical utility of the oncoReveal Dx, which is the first FDA-approved multi-cancer IVD launched in the market," said Randy Pritchard, CEO of Pillar Biosciences. "With our innovative technology platform, we built an assay with extraordinary sensitivity, simple workflow, and fast turnaround time to enable localized testing that can be performed in any NGS lab, whether hospital-based or a commercial reference laboratory. This localized approach demonstrates our commitment to bringing highly accurate and actionable NGS testing to clinical laboratories and biopharmaceutical companies in order to help improve treatment decisions and outcomes that are accessible to everyone, everywhere.

The Pan-cancer oncoReveal CDx is developed for tumor profiling and therapy selection, and includes actionable targets on ten of the most common cancer types. The panel provides comprehensive genomic results, covering 22 clinically relevant genes in one multiplex reaction, and has a fully automatable workflow that can be performed by any clinical laboratory with a sample-to-report time of as little as 48 hours.

The PMA supplement application follows the original PMA approval of oncoReveal Dx Lung & Colon Cancer Assay in July 2021.