On April 23, 2024 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, reported 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) (Press release, Pillar Biosciences, APR 23, 2024, View Source [SID1234642255]). 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.

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"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 Pillar Biosciences. "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. This approach demonstrates our commitment to bringing highly accurate, actionable, and reimbursable NGS testing to clinical laboratories and biopharmaceutical companies to help improve treatment decisions and deliver outcomes that are accessible to everyone, everywhere."

"Illumina is proud to partner with Pillar Biosciences to expand diagnostic offerings on the MiSeq Dx," said Kevin Keegan, General Manager of Oncology at Illumina. "Broadening the market for tumor profiling and therapy selection options is a key enabler of precision medicine and harnesses the power of the genome to improve human health."

The oncoReveal CDx pan-cancer solid tumor IVD, which has been validated and approved for use on the Illumina MiSeq Dx System, was developed for tumor profiling and therapy selection and includes actionable targets on most common solid cancer types. The panel covers 22 clinically relevant genes in one multiplex reaction and has a single-day workflow that can be performed by any clinical laboratory 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.

This PMA supplement approval follows the original PMA approval of oncoReveal Dx in July 2021. This IVD is also currently CE IVD approved on MiSeq Dx for EGFR & KRAS for therapy selection in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), and NMPA approved in China for KRAS, BRAF and PIK3CA for therapy selection in CRC.