Illumina to move its oncology assay into blood-based cancers with companion diagnostic partnership

Following the launch of multiple tumor diagnostic partnerships with Big Pharma earlier this year for its TruSight Oncology 500 assay, Illumina now aims to expand the use of its genomic profiling test to blood-based cancers.

The sequencing giant has inked a deal with Kartos Therapeutics to co-develop a companion diagnostic for the biotech’s KRT-232, an oral inhibitor that helps spur on tumor-suppressing proteins in cancers with certain mutations. The drug is currently being studied in myelofibrosis, Merkel cell carcinoma, acute myeloid leukemia, B-cell malignancies and chronic myelogenous leukemia. 

The planned companion diagnostic will span multiple hematologic indications and will be the TruSight assay’s first use of drawn blood samples for analysis. In a statement, Illumina’s Chief Medical Officer Phil Febbo said the company hopes to deliver a standardized, globally distributable test for precision oncology providers.

At the top of this year, Illumina announced new collaborations with Bristol Myers Squibb, Merck, Myriad Genetics and Kura Oncology to develop TruSight into separate companion tests, for identifying specific genetic mutations, DNA repair deficiencies or microsatellite instability status.

CEO Francis deSouza said during the virtual J.P. Morgan Healthcare Conference in January that the company plans to launch the assay as a regulated in vitro diagnostic test this year in both the U.S. and Europe. Illumina has also been pursuing similar projects with Roche, Bayer and Eli Lilly’s Loxo Oncology.

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At the same time, Illumina has pledged to continue its pursuit for the multi-cancer blood test developer Grail, after the Federal Trade Commission said it would object to the $8 billion buyout proposed last year.

Formerly an Illumina spinout itself, the return of the prodigal Grail would give the company deeper reach into the clinical testing markets—which the FTC said could harm the development of other early cancer detection tests, with Illumina’s instruments being widely used by Grail’s potential competitors.

The acquisition is also being examined by the European Commission’s watchdog arm, though deSouza said in a statement that the company does not believe European authorities have jurisdiction to review the deal.

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Earlier this month, Illumina reported $1.09 billion in preliminary first-quarter revenue, up about 26% compared to the previous year’s $859 million—a trend the company said it expects to see continue through the remainder of 2021.

Illumina said it saw record orders during the first three months of this year, with instrument sales growing about 120%. At the same time, sequencing consumables were up about 25%—as its customers’ testing businesses return to pre-pandemic levels—while COVID-19 sequencing revenues alone accounted for about $20 million in sales. The company’s full financial results are expected next week.