– PMA supplement will further expand oncoReveal™ Dx indication/label to include ability to detect additional eight cancer types
˗ Company continues to execute on its strategy to bring highly accurate and sensitive NGS cancer diagnostics to enable localized testing
NATICK, Mass. – July 19, 2022 – (BUSINESS WIRE) – 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, today announced 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. 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.
“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.
About Pillar Biosciences
Pillar Biosciences is the leader in Decision Medicine™, which is the utilization of highly accurate and sensitive next-generation sequencing (NGS) testing technology to generate data that optimizes selection of precision therapies for cancer patients, from tumor profiling to therapy selection, and recurrence monitoring. Pillar’s NGS testing solutions, including the FDA-approved oncoReveal™ Dx Lung and Colon Cancer Assay, are powered by the Company’s proprietary SLIMamp® and PiVAT® technologies, and decentralizes the testing process, reducing diagnostic costs and improving access and efficiency of complex NGS testing for clinicians, prescribers, and patients globally. The Company has more than 20 NGS testing products available in IVD or RUO formats, and several others in various stages of development, including a pan-cancer oncoReveal™ CDx assay, and two liquid biopsy offerings. Pillar’s patented technologies have been shown to provide accurate and actionable data in as little as 48 hours, which allows physicians to select appropriate therapies and monitor the patient’s response. Pillar Biosciences has operations in Natick, MA and Shanghai, China. For more information, visit www.pillar-biosciences.com.
Joshua R. Mansbach