Illumina and Loxo Oncology Join Forces to Develop Pan-Cancer Companion Diagnostics


Illumina is teaming up with Loxo Oncology to develop and commercialize a multi-gene panel for broad cancer profiling. It will seek approval for a version of Illumina’s TruSight Tumor 170 as a companion diagnostic for Loxo Oncology’s larotrectinib and LOXO-292.

TruSight Tumor 170 is a next-generation sequencing test that tests point mutations, fusions, amplifications and splice variants in 170 genes linked to common solid tumors. The companion diagnostic version of the TruSight Tumor 170 would let independent local laboratories provide referring physicians with genomic information that can assist in selecting the best medications for specific cancers. The test will operate on Illumina’s NextSeq 550Dx platform.

Loxo’s larotrectinib is a drug that targets NTRK gene fusions. And LOXO-292 targets RET gene alterations. Both drugs have potential applications across tumor types. Larotrectinib has received Breakthrough Therapy Designation, Rare Pediatric Disease Designation and Orphan Drug Designation by the U.S. Food and Drug Administration (FDA). In November 2017, Loxo and Bayer inked an exclusive global collaboration to develop and commercialize the drug, as well as LOXO-195, a next-generation TRK inhibitor. Bayer and Loxo Oncology will develop the two products jointly.

LOXO-292 is currently being evaluated in a Phase I trial. The drug is being studied in cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. These fusions are seen in about 2 percent of non-small cell lung cancer (NSCLC), 10 to 20 percent of papillary thyroid cancer, and subsets of colon and other cancers.

“We are very excited to announce this collaboration with Illumina, the world’s leader in NGS technology,” said Jacob Van Naarden, Loxo’s chief business officer, in a statement. “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.”

In January 2016, Illumina launched Grail Bio, with financial backers ARCH Venture Partners, Sutter Hill Ventures, and Bezos Expeditions, run by Amazon founder and chief executive officer Jeff Bezos, and Microsoft co-founder Bill Gates. The goal of Grail Bio is to create a “pan-cancer” screening test that can diagnose any cancer at an early stage prior to symptoms. The Series A financing exceeded $100 million.

Grail merged in May 2017, with Hong Kong-based Cirina. Cirina was co-founded by leaders in non-invasive molecular diagnostics, Dennis Lo, Rossa Chiu and Allen Chan at the Chinese University of Hong Kong (CUHK), and lead investor, Decheng Capital.

Of today’s deal with Loxo, Garret Hampton, Illumina’s executive vice president of Clinical Genomics, stated, “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.”

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