Illumina San DiegoGenetic testing company, Illumina and drug developer, Loxo Oncology have announced a global strategic partnership to develop a diagnostic tool that will work with Loxo’s larotrectinib and another of its experimental cancers drugs, across tumour types.

The companies said the partnership will seek approval for a version of the Illumina TruSight Tumor 170, which will allow local laboratories to provide referring physicians with comprehensive genomic information, so that patients can be matched to the most appropriate therapeutic options. 

Larotrectinib targets acquired genetic defects, called NTRK gene fusions, and LOXO-292 targets RET gene alterations, across tumour types.

TruSight Tumor 170 is a comprehensive, next-generation sequencing test that interrogates point mutations, fusions, amplifications and splice variants in 170 genes associated with common solid tumours. 

 

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“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,” said Garret Hampton, Ph.D., Executive Vice President of Clinical Genomics at Illumina. 

According to Reuters, wall street analysts expect U.S. approval for larotrectinib this year, and forecast annual sales of $500 million to $1 billion. 

The companies are also planning to broaden the clinical utility of the full panel by obtaining regulatory approval for the other assay content, to be marketed as a tumour profiling test. Illumina will lead regulatory activities related to the Class III plans for NTRK and RET, the Class II plans for the tumour profiling content and CE marking.

“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,” said Jacob Van Naarden, Chief Business Officer of Loxo Oncology. “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.”