The US Food and Drug Administration has recently granted approval for Pillar Biosciences’ OncoReveal CDx pan-cancer in vitro diagnostic to be utilized as a comprehensive solid tumor profiling test, marking a significant expansion of its previous approval scope. Initially approved in 2021 for guiding targeted therapies in patients with specific non-small cell lung and colorectal cancers based on EGFR and KRAS mutations, this supplemental premarket approval broadens its utility to encompass a wider array of solid tumors.
This latest regulatory clearance enables hospitals and commercial laboratories equipped with Illumina MiSeq next-generation sequencing platforms to integrate OncoReveal into their diagnostic repertoire. The collaboration between Pillar and Illumina, initiated last year, facilitated the inclusion of Pillar’s suite of oncology tests within Illumina’s portfolio of cancer products, enhancing accessibility and adoption.
OncoReveal distinguishes itself through its tissue-based companion diagnostic approach, leveraging Pillar’s proprietary Slimamp target enrichment chemistry. This methodology ensures selective amplification of target DNA regions while effectively blocking unwanted sections, enabling precise analysis. The test evaluates 22 clinically significant genes, providing comprehensive insights, and boasts an impressive turnaround time, completing 46 batches within 48 hours.
Beyond its FDA approval, OncoReveal has garnered regulatory clearances elsewhere, being CE-marked in Europe for guiding EGFR and KRAS-targeted therapies in non-small cell lung cancer and colorectal cancer patients. Additionally, it has received approval in China for selecting therapies targeting KRAS, BRAF, and PIK3CA mutations in colorectal cancer patients.
The expanded approval of OncoReveal underscores its pivotal role in advancing personalized medicine, offering clinicians a powerful tool to inform treatment decisions across various solid tumor types, ultimately enhancing patient care and outcomes.