Illumina, Loxo strike pan-cancer NGS companion diagnostic deal

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The test will run on Illumina’s NextSeq 550Dx platform at local laboratories. (Illumina)

Loxo Oncology has picked Illumina as its companion diagnostic partner for larotrectinib and LOXO-292. Illumina will use next-generation sequencing technology TruSight Tumor 170 as the basis for a test that identifies the NTRK fusions and RET gene alterations targeted by Loxo’s drugs.

Today, TruSight is used by researchers to analyze fusions and other alterations in 170 genes linked to solid tumors. In turning the test into a companion diagnostic, Illumina and Loxo will validate its ability to detect markers pertinent to larotrectinib and LOXO-292 and secure an FDA Class III approval and a CE mark. The test will run on Illumina’s NextSeq 550Dx platform at local laboratories.

Loxo picked Illumina over other companies competing for its companion diagnostic business after taking TruSight and its rivals for test drives.

“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,” Loxo Chief Business Officer Jacob Van Naarden said in a statement. “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.”

The decision to go with Illumina also had a commercial component. Loxo thinks pathologists will be able to perform the test locally and receive reimbursement, thereby broadening patient access to the diagnostic and the drugs. With Bayer having paid $400 million upfront to buy into larotrectinib, a lot is resting on the breadth of patient access to the drug.

For Illumina, the Loxo deal furthers its push to apply its NGS capabilities to in vitro diagnostics that improve cancer care.