Company officials describe the technology as a multi-gene panel for broad tumor profiling, with the goal of creating a distributable, next-generation sequencing-based companion diagnostic (CDx) with a pan-cancer indication. A CDx version of Illumina’s TruSight Tumor 170 product will allow local laboratories to provide referring physicians with comprehensive genomic information, so that patients can be matched to the most appropriate therapeutic options.
Illumina will lead the regulatory activities to bring the collaborative results to commercial distribution. Their TruSight Tumor 170 is described as a sequencing test that interrogates point mutations, fusions, amplifications and splice variants in 170 genes associated with common solid tumors. Loxo Oncology’s larotrectinib targets NTRK gene fusions, while its LOXO-292 targets RET gene alterations, across tumor types. In this partnership, the companies will collaborate on a CDx version of TruSight Tumor 170 for NTRK fusions and RET fusions/mutations as a Class III FDA-approved diagnostic in conjunction with larotrectinib and LOXO-292.
“The broad 170-gene assay content has the potential to deliver meaningful insights from a single tumor specimen, identifying patients with NTRK fusions, RET fusions, RET mutations, and many other actionable tumor alterations,” said Jacob Van Naarden, chief business officer of Loxo Oncology. “Furthermore, we believe that this collaboration will improve patient access to high-quality NGS testing because pathologists will be able to run TruSight Tumor 170 locally and receive reimbursement.”