Illumina and Loxo Oncology have partnered on the development of next-generation sequencing-based pan-cancer companion diagnostics.

The companies will develop and commercialize a multi-gene panel for broad tumor profiling, leading to a distributable, next-generation sequencing (NGS) based companion diagnostic (CDx) with a pan-cancer indication.

Approval will be sought for a version of the Illumina TruSight Tumor 170 as a companion diagnostic (CDx) for Loxo Oncology’s larotrectinib. 

Larotrectinib targets NTRK gene fusions, and LOXO-292, which targets RET gene alterations, across tumor types.

TruSight Tumor 170 is a sequencing test that interrogates point mutations, fusions, amplifications and splice variants in 170 genes which are associated with common solid tumors.

The CDx version of TruSight Tumor 170 will allow local laboratories to offer comprehensive genomic information to referred physicians, so that the most appropriate therapeutic options available for the patients can be suggested. This version of TruSight Tumor 170 will run on the NextSeq 550Dx platform.

Illumina clinical genomics executive vice president Garret Hampton said: “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.

“To this end, we are partnering with leading biotechnology companies, such as Loxo Oncology, to develop companion diagnostics for best-in-class therapeutics. Distributable diagnostic solutions, such as a CDx version of TruSight Tumor 170, in combination with the NextSeq 550Dx platform, will enable labs to perform precision medicine testing in-house.”

As per the partnership, the two companies will collaborate on the validation of a CDx version of TruSight Tumor 170 for NTRK fusions and RET fusions/mutations as a Class III FDA-approved diagnostic in combination with larotrectinib and LOXO-292, respectively.

The companies are also planning to expand clinical use of a full panel by securing regulatory approval for the other assay content, which will be marketed as a tumor profiling test.

Illumina will lead regulatory activities related to the Class III plans for NTRK and RET, the Class II plans for the tumor profiling content and CE marking.

Loxo Oncology chief business officer Jacob Van Naarden said: “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.

“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. 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.”

Image: Illumina's Building. Photo: Courtesy of Illumina, Inc.