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FDA Approves Pillar Biosciences Pan-Cancer NGS Test for Solid Tumor Profiling

This story has been updated to clarify that OncoReveal can complete 46 samples in 48 hours, rather than 46 batches.

NEW YORK – The US Food and Drug Administration has approved Pillar Biosciences' OncoReveal CDx pan-cancer in vitro diagnostic as a general solid tumor profiling test, the company said Tuesday.

The FDA originally granted premarket approval to OncoReveal in 2021 for guiding specific EGFR- and KRAS-targeted therapy for patients with non-small cell lung and colorectal cancer. The latest supplemental premarket approval will allow any hospital or commercial lab running an Illumina MiSeq Dx next-generation sequencing platform to adopt OncoReveal as a general tumor profiling test. Pillar and Illumina inked a deal last year to offer Pillar's suite of oncology tests as part of Illumina's portfolio of cancer products.

OncoReveal is a tissue-based companion diagnostic that uses Pillar's amplicon-based SLIMamp target enrichment chemistry, which allows selective amplification of target DNA regions of interest and blocks unwanted sections. The test gauges 22 clinically relevant genes and can complete 46 samples in 48 hours.

OncoReveal is also CE-marked for EGFR- and KRAS-targeted therapy selection for NSCLC and colorectal cancer patients in Europe and approved in China for KRAS-, BRAF-, and PIK3CA-targeted therapy selection for colorectal cancer patients.