Pillar Biosciences Gets CPT Code for FDA-Approved oncoReveal CDx Pan-Cancer IVD Kit

NATICK, Mass., Oct. 24, 2024 – Pillar Biosciences, Inc., a leading company in Decision Medicine™, has announced that it has been awarded a unique CPT® Proprietary Laboratory Analyses (PLA) code 0523U by the American Medical Association (AMA) for its FDA-approved oncoReveal™ CDx pan-cancer solid tumor in vitro diagnostic (IVD) NGS kit.

The oncoReveal™ CDx is an NGS-based IVD kit that employs Pillar's proprietary SLIMamp (Stem-Loop Inhibition-Mediated amplification) technology to detect single nucleotide variants (SNVs), insertions, and deletions in 22 genes from DNA extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissue samples. The oncoReveal™ CDx has received FDA clearance for use on the Illumina MiSeq™ Dx platform.

This assay kit is designed to provide a comprehensive mutation profile of pan-cancer tumors. It is intended for use by qualified healthcare professionals following professional oncology guidelines for patients with previously diagnosed solid malignant neoplasms. Additionally, the oncoReveal™ CDx has been approved as a companion diagnostic tool to identify patients who may benefit from EGFR TKI therapy in non-small cell lung cancer (NSCLC) and from ERBITUX® and VECTIBIX® for KRAS mutations in colorectal cancer (CRC).

Brian Wright, Chief Marketing Officer of Pillar Biosciences, expressed pride in achieving this milestone with the oncoReveal™ CDx, noting that it was the first FDA PMA-approved multi-cancer IVD kit on the market. In partnership with Illumina, Pillar Biosciences has made rapid and affordable NGS testing accessible for local NGS laboratories. Wright emphasized their commitment to developing precise, actionable, and reimbursable NGS tests to aid clinical laboratories and biopharmaceutical companies in improving treatment decisions and delivering accessible outcomes globally.

Pillar Biosciences is at the forefront of Decision Medicine™, utilizing advanced next-generation sequencing (NGS) technology to optimize the selection of precision therapies for cancer patients. This ranges from tumor profiling to therapy selection and monitoring for recurrence. The company's NGS testing solutions are driven by its proprietary SLIMamp® and PiVAT® technologies, aimed at localizing the testing process, cutting diagnostic costs, and enhancing the accessibility and efficiency of complex NGS testing for clinicians, prescribers, and patients worldwide. Pillar Biosciences offers over 20 NGS testing kits available in IVD or RUO formats, with several panels under development. The company operates out of Natick, MA.

Pillar Biosciences continues to advance its mission of enhancing the precision of cancer therapy selection through innovative NGS technologies, offering significant improvements in the efficiency and accessibility of genetic testing for oncology.