Pillar Biosciences Receives CPT® Code for FDA Approved oncoReveal™ CDx Pan-Cancer Solid tumor IVD Kit

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Oct 24, 2024, 10:00 ET

NATICK, Mass., Oct. 24, 2024 /PRNewswire/ -- Pillar Biosciences, Inc., the leader in Decision Medicine™, today announced that they have been granted a unique CPT® Proprietary Laboratory Analyses (PLA) code 0523U from the American Medical Association (AMA) for their FDA approved oncoReveal™ CDx pan-cancer solid tumor in vitro diagnostic (IVD) NGS kit.

oncoReveal™ CDx is a NGS based IVD kit that uses Pillar's proprietary SLIMamp (Stem-Loop Inhibition-Mediated amplification) technology for detection of single nucleotide variants (SNVs), insertions and deletions in 22 genes using DNA isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens. oncoReveal^™ CDx has been FDA cleared on the Illumina MiSeq^™ Dx.

The oncoReveal™ CDx assay kit is intended to provide pan-cancer tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for previously diagnosed cancer patients with solid malignant neoplasms. oncoReveal^™ CDx has also been approved as a companion diagnostic to identify patients who may benefit from EGFR TKI therapy (class approval) in NSCLC and ERBITUX® and VECTIBIX® for KRAS in CRC.

"We are proud of achieving this milestone in the launch of oncoReveal™ CDx, which was the first FDA PMA-approved multi-cancer IVD kit launched in the market," said Brian Wright, Chief Marketing Officer of Pillar Biosciences. "In partnership with Illumina, we have enabled rapid and affordable NGS testing to be performed locally in any NGS lab. We are committed to developing and bringing highly accurate, actionable, and reimbursable NGS testing to clinical laboratories and biopharmaceutical companies to help improve treatment decisions and deliver outcomes that are accessible to everyone, everywhere."

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 are powered by its proprietary SLIMamp® and PiVAT® technologies, helping to localize the testing process, reduce diagnostic costs and improve access and efficiency of complex NGS testing for clinicians, prescribers, and patients globally. The company has more than 20 NGS testing kits available in IVD or RUO formats, with multiple panels in various stages of development. Pillar Biosciences has operations in Natick, MA. For more information visit pillarbiosci.com and connect with us on LinkedIn.

SOURCE Pillar Biosciences, Inc.