In precision oncology, an unclassified genetic variant is an excluded patient. When regulators require evidence-backed rationale for every variant included in a companion diagnostic, incomplete classification does not just slow the process. It shrinks the label and limits patient access.
Your program should not carry evidence risk it does not have to. With Genomenon, it will not.
This case study documents how Genomenon supported Loxo@Lilly in securing PMDA approval for Retevmo (selpercatinib) by building a comprehensive RET variant evidence package. Genomenon applied AI-powered search across the full-text published literature and expert curation using ACMG/AMP-based oncogenicity classification criteria across single-nucleotide variants, indels, copy number variants, and supplemental genomic data. The result was the detailed, variant-level regulatory evidence package PMDA required, delivered on the timeline the submission demanded.
The Outcome: 73 additional RET variants included in the Retevmo label. 8 variants removed on counter-evidence. A 4.1x increase in eligible RET variants. 15% more eligible medullary thyroid cancer patients.
