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Illumina, Loxo Oncology to Develop Pan-Cancer Companion Diagnostic

NEW YORK (GenomeWeb) – Illumina and Loxo Oncology said today that they plan to develop sequencing-based pan-cancer companion diagnostics for two of Loxo's targeted oncology drugs.

The companies will use a version of Illumina's TruSight 170 panel, a hybrid capture panel launched in the beginning of 2017 that analyzes both DNA and RNA. The test will be run on Illumina's NextSeq 550Dx platform.

The two companies aim to validate the panel for NTRK fusions and RET fusions/mutations as a Class III US Food and Drug Administration-approved diagnostic in conjunction with Loxo's larotrectinib and LOXO-292, respectively. Last year, Loxo presented clinical data on larotrectinib as treatment for patients whose tumors had TRK fusions. Loxo is currently conducting a Phase I clinical trial for LOXO-292.

In addition, the companies plan to seek regulatory approval for the other content on the TST 170 panel to be marketed as a Class II tumor profiling test. Illumina will also seek CE marking for the assay.

Loxo's Chief Business Officer Jacob Van Naarden said in a statement that the company has tested a number of different NGS assays and that TST 170 "consistently demonstrated robust performance with its assessment of DNA and RNA," and could identify patients with NTRK fusions, RET fusions, RET mutations and other alterations.