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

NextEdge Admin

01 Aug 2024

3 min 6 sec

Molecular Pathology Laboratory Network, Inc.,NGS testing,CDx

Pillar Biosciences, Inc., a leader in Decision Medicine™, has announced that Molecular Pathology Laboratory Network, Inc. (MPLN) is the first national molecular reference laboratory to verify and launch the oncoReveal™ CDx pan-cancer solid tumor IVD kit. This kit, which has received FDA PMA approval, enables comprehensive tumor profiling for 22 clinically relevant genes across all solid tumors. It includes specific companion diagnostic claims for KRAS in colorectal cancer and EGFR in non-small cell lung cancer. The oncoReveal™ CDx kit features a rapid single-day workflow and can be used by any clinical laboratory equipped with an Illumina MiSeq™ Dx platform, allowing an integrated sample-to-report time of just 48 hours and processing up to 46 clinical samples per run.

Dr. Roger Hubbard, CEO of MPLN, highlights the importance of this diagnostic tool in swiftly identifying cancer patients for first-line targeted therapies or clinical trials. MPLN verified the full IVD assay within two weeks of training, showcasing its quick implementation. MPLN plans to collaborate with its physician network and biopharma partners to integrate this innovative solid tumor IVD product into clinical practice.

Dan Harma, Chief Commercial Officer of Pillar Biosciences, addresses the increasing regulatory pressures on CLIA-certified molecular reference laboratories and underscores the benefits of the oncoReveal™ CDx. This FDA-approved assay can be rapidly verified and performed in any lab with an Illumina MiSeq™ Dx platform, reducing delays in patients receiving targeted therapy and improving overall patient care.

Pillar Biosciences focuses on Decision Medicine™, utilizing next-generation sequencing (NGS) technology to enhance precision therapy selection, from tumor profiling to therapy selection and recurrence monitoring. Their proprietary SLIMamp® and PiVAT® technologies streamline the testing process, lowering diagnostic costs and improving access to NGS testing globally. MPLN, a pioneer in laboratory medicine since 1989, specializes in women's health and oncology, offering advanced molecular diagnostics, specialty pathology, and superior customer service to healthcare providers nationwide.