Illumina (NSDQ:ILMN) and Loxo Oncology (NSDQ:LOXO) are teaming up to develop a multi-gene panel for broad tumor profiling. The two companies ultimately hope to sell a next-gen sequencing-based companion diagnostic that will boast a pan-cancer indication.
Illumina and Loxo plan to seek approval for a version of Illumina’s TruSight Tumor 170 test as a companion diagnostic for two of Loxo’s drugs; larotrectinib, which targets NRTK gene fusions, and Loxo-292, which targets RET gene alterations.
Illumina’s TruSight Tumor 170 system is a sequencing test that probes point mutations, fusions, amplifications and splice variants in 170 genes associated with solid tumors, the company explained. The companion diagnostic version of TruSight Tumor 170 will be designed to help guide physicians to appropriate therapeutic options for their patients based on comprehensive genomic information.
According to the terms of the partnership, Illumina will lead regulatory activities as the companies pursue a Class III designation for its diagnostic system with the FDA.
“We are leveraging our leadership in next-generation sequencing to deliver in-vitro diagnostic solutions to improve the management of cancer patients in the clinic,” Garret Hampton, EVP of clinical genomics at Illumina, said in prepared remarks. “To this end, we are partnering with leading biotechnology companies, such as Loxo Oncology, to develop companion diagnostics for best-in-class therapeutics.”
“We have piloted numerous NGS assays, and the Illumina TruSight Tumor 170 assay has consistently demonstrated robust performance with its assessment of both DNA and RNA, including highly sensitive gene fusion detection,” Loxo’s chief business executive, Jacob Van Naarden, added. “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.”
