Many laboratories are interested in bringing oncology NGS testing in-house, but implementation can feel complex, resource-intensive, and difficult to operationalize. An IVD test can help simplify this process by offering a more turnkey approach that reduces the burden of implementation.

In this webinar, experts will share practical guidance on IVD test verification, a real-world laboratory verification example, integrated software and reporting workflows that reduce the need for bioinformatics expertise, and the current reimbursement pathway.

Join us to learn how an IVD approach can support a more streamlined path from implementation planning to daily operations.

Talk 1: Reducing Implementation Complexity: IVD Test Verification for Oncology NGS; Dr. Xia Li, Medical Director of the Molecular Pathology Laboratory at Clin-Path Associates, PLC and Associate Professor of Pathology at the University of Arizona.
Learn how IVD test verification differs from LDT validation and how an IVD approach can help simplify oncology NGS implementation, including practical guidance on verification study scale and sample selection aligned with relevant guidelines.

Talk 2: From Protocol to Practice: How One Lab Verified the Oncomine Dx Express Test; Dr. Gary Pestano, PhD., Chief Development Officer, Biodesix, Inc.
Hear a real-world example of how one laboratory planned and executed verification of the Oncomine Dx Express Test, including practical lessons learned.

Talk 3: From Run Setup to Report Sign-Out: Simplifying Bioinformatics and Reporting with an IVD Test; Dr. Theresa Wheeler, Sr Manager Product Manager, Thermo Fisher Scientific
See how a single integrated software solution can simplify oncology NGS analysis by automating analysis, QC, and results generation, while guiding users from run setup to report sign-out without requiring bioinformatics expertise.

Talk 4: Reimbursement Pathway Update: Current Status and Next Steps; Dr. Jeff Smith, Director Precision Medicine, Thermo Fisher Scientific
Get a brief update on the current Oncomine Dx Express Test reimbursement pathway status and anticipated next steps for laboratories evaluating implementation

Disclaimers:

For in vitro diagnostic. CE IVD

Approved in US by FDA as a companion diagnostic (CDx) to identify non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations for treatment with ZEGFROVY™ (sunvozertinib) in accordance with the approved therapeutic product labeling. The Oncomine Dx Express Test detects biomarkers recommended by professional guidelines for multiple solid tumors, including substitutions, insertions, and deletions in 42 genes, copy number variants in 10 genes, and fusions or splice variants in 18 genes.

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