Pillar Biosciences’ FDA-Approved Solid Tumor NGS Kit oncoReveal™ CDx Launched at Molecular Pathology Laboratory Network, Inc.

Home » Pillar Biosciences’ FDA-Approved Solid Tumor NGS Kit oncoReveal™ CDx Launched at Molecular Pathology Laboratory Network, Inc.

Pillar Biosciences’ FDA-Approved Solid Tumor NGS Kit oncoReveal™ CDx Launched at Molecular Pathology Laboratory Network, Inc.

  • Biopharma, Industry News, Next-Generation Sequencing, Oncology

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PR Newswire
Pillar Biosciences, Inc. 

Jul 30, 2024, 09:15 ET

NATICK, Mass., July 30, 2024 /PRNewswire/ — Pillar Biosciences, Inc., the leader in Decision Medicine™, has announced that Molecular Pathology Laboratory Network, Inc. (MPLN) is now the first national molecular reference laboratory to verify and launch oncoReveal™ CDx.

The oncoReveal™ CDx pan-cancer solid tumor IVD kit has been FDA PMA approved for general tumor profiling for 22 clinically relevant genes across all solid tumors, including CDx claims for KRAS (Erbitux® & Vectibix®) in colorectal cancer (CRC) and EGFR (TKI Class Approval) in non-small cell lung cancer (NSCLC). oncoReveal™ CDx has a rapid single-day workflow that can be performed by any clinical laboratory enabled with an Illumina MiSeq™ Dx platform with an integrated sample-to-report time of as little as 48 hours. Up to 46 clinical samples can be performed on a single MiSeq™ Dx run.

“We are proud to partner with Pillar Biosciences on the global launch of this important IVD assay kit,” said Dr. Roger Hubbard, Ph.D., Chief Executive Officer, Molecular Pathology Laboratory Network. “MPLN’s goal is to bring innovative technologies to diagnostic care and clinical trial studies. We see this diagnostic assay as an important clinical tool to help quickly select certain cancer patients for 1st line targeted therapy or clinical trials. Given this assay was an FDA-approved kit, our laboratory team was quickly able to perform full IVD assay verification within 2 weeks of training. We look forward to working with our physician network and biopharma partners to implement this new solid tumor IVD product.”

“The potential of increased FDA regulation on LDTs is putting immense pressure on CLIA-certified molecular reference laboratories,” said Dan Harma, Chief Commercial Officer, Pillar Biosciences. “The launch of our oncoReveal™ CDx now enables these laboratories with an FDA approved solid tumor assay which can be quickly and easily verified and performed in any laboratory with an Illumina MiSeq™ Dx NGS platform to rapidly profile patients with solid tumors. We see this as a great opportunity to improve care and reduce the delay in patients receiving targeted therapy.”

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.

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At MPLN, we are committed to providing personalized, actionable results that enhance patient care. Our breadth of advanced technologies equips clinicians with accurate diagnoses, risk stratification, and treatment options. Led by Chief Medical Officer Mark Stonecypher, MD, PhD, our team of board-certified pathologists offers evidence-based testing, streamlined diagnostics, consultations, and a single-page summary for ease, ensuring each patient receives the individualized care they deserve.

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SOURCE Pillar Biosciences, Inc.
https://www.pillarbiosci.com/news/pillar-biosciences-fda-approved-solid-tumor-ngs-kit-oncoreveal-cdx-launched-at-molecular-pathology-laboratory-network-inc/

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