Therapy Areas: Respiratory
US Food and Drug Administration Accepts Pillar Biosciences Premarket Approval Supplement Application for Pan-cancer oncoReveal CDx
19 July 2022 - - The US Food and Drug Administration has accepted for review US-based Pillar Biosciences' Premarket Approval supplement application for its Pan-cancer oncoReveal CDx, the company said.

The supplement, if approved, will expand the label/indication of Pillar Bioscience's oncoReveal Dx Lung and Colon Cancer Assay to include actionable targets for eight additional cancer types, bringing the total detectable cancers to ten.

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 and Colon Cancer Assay in July 2021.

Pillar Biosciences utilizes next-generation sequencing 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.