Webinar

Pillar Biosciences’ oncoReveal™ CDx Pan-Cancer Solid Tumor IVD: A Rapid FDA Approved NGS Kit to Help Drive Actionable and Accessible Localized Testing.

On-demand

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

Tiffany Guess

Cytogenomics Lab Director, Molecular Pathology Lab Network (MPLN)

Dr. Tiffany Guess is a board-certified clinical laboratory geneticist with over 20 years’ experience in cytogenetics and molecular genetics. She received her PhD in Molecular Biosciences from Middle Tennessee State University and completed a clinical laboratory fellowship at Vanderbilt University Medical Center. Dr. Guess is the Cytogenomics Director at Molecular Pathology Laboratory Network (MPLN)/Geneuity in Maryville, Tennessee where she oversees cytogenetic, FISH, and molecular genetic testing for clinical and clinical trial patients.

Nicholas Lodato

Principal Scientist, Pillar Biosciences

Dr. Nicholas Lodato is a Principal Scientist at Pillar Biosciences and has spent the last seven years developing new amplicon-based targeted panels for the detection of low-frequency variants in circulating cell free DNA and solid tumors, including the FDA-approved oncoReveal Dx Lung and Colon Cancer Assay. He received his Ph.D. in Cell and Molecular Biology at Boston University, where he researched epigenetic mechanisms of gene regulation and liver disease using mouse models.