Access to rapid, reproducible and accurate NGS kitted assays are important as many laboratories navigate the FDA / LDT Final Rule and are required to provide faster NGS results to treating clinicians.
Pillar Biosciences oncoReveal™ CDx is a recently FDA approved, rapid NGS-based IVD kit detecting SNVs, insertions and deletions in 22 genes using DNA isolated from FFPE tumor tissue specimens sequenced on the Illumina MiSeqDx instrument. The assay provides a single-day workflow, with an integrated clinical report, enabling laboratories to provide NGS results to their clinicians in approximately 48 hours. The IVD kit has CDx claims for KRAS (ERBITUX® and VECTIBIX® in CRC and EGFR (Full EGFR-TKI Class Approval) as well claims for pan-cancer general tumor profiling.
Using this test, laboratories can immediately address challenges associated with impending regulation as well as provide rapid NGS results to their stakeholders- ensuring more patients get on the appropriate targeted therapy, faster.
Webinar Learning Objectives
Provide a detailed technical overview of the oncoReveal™ CDx IVD assay, review the simple NGS workflow, and discuss the analytical and clinical validation data in support of Pillar's FDA approval.
Review of a clinical laboratory’s experience verifying the oncoReveal™ CDx assay.
Explain the utility of oncoReveal in a commercial laboratory that processes both clinical and clinical research/clinical trial samples.
Highlight the CDx component as it relates to current guidelines for colon cancer (WHO and/or NCCN).
Provide example reports of colon cancer samples tested via oncoReveal™ CDx and discuss benefits/limitations of reporting
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