Loxo Oncology has entered into a global strategic alliance with Illumina for the development and commercialisation of pan-cancer companion diagnostics (CDx).
The multi-gene panel is set to target broad tumour profiling and will be based on Illumina’s next-generation sequencing (NGS) test, TruSight Tumor 170.
Loxo and Illumina intend to jointly work towards the approval of the CDx version of TruSight Tumor 170 for the former’s larotrectinib and LOXO-292 drugs.
Intended for the treatment of various cancer types, larotrectinib targets NTRK gene fusions, while LOXO-292 addresses RET gene alterations.
Illumina clinical genomics executive vice-president Garret Hampton said: “We are leveraging our leadership in NGS 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 CDxs for best-in-class therapeutics.”
TruSight Tumor 170 is designed to check for point mutations, fusions, amplifications and splice variants in 170 genes that are known to be associated with common solid tumours.
The CDx version of the NGS test is expected to deliver the comprehensive genomic information required for physicians to decide correct treatment for patients.
This version will be assessed under the co-development partnership for NTRK fusions and RET fusions/mutations, with plans to expand the panel’s clinical utility as a tumour profiling test.
Loxo Oncology chief business officer Jacob Van Naarden said: “The broad 170-gene assay content has the potential to deliver meaningful insights from a single tumour specimen, identifying patients with NTRK fusions, RET fusions, RET mutations, and many other actionable tumour 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.”
Illumina will be responsible for the regulatory activities related to the Class III US Food and Drug Administration (FDA) approval for NTRK and RET, Class II plans for the tumour profiling content, and CE marking.