JPM: Illumina inks multiple cancer diagnostic partnerships to complement upcoming Grail acquisition

Following its $8 billion pitch last year to acquire Grail and its upcoming multi-tumor blood test, Illumina is planning a deeper dive into cancer genomics with a slew of new biopharma development partnerships.

Centered around its TruSight Oncology 500 sequencing assay, the sequencing giant has inked collaborations with Bristol Myers Squibb, Merck, Myriad Genetics and Kura Oncology. They join previous projects with the likes of Roche, Bayer and Eli Lilly’s Loxo Oncology.

The TruSight assay is currently for research use only, and uses both DNA and RNA from tumor samples to identify key genetic alterations linked to cancer growth and progression.

Illumina plans to use the findings from the assay to develop companion diagnostic tests for specific cancer treatments, including for Bristol Myers Squibb’s global oncology portfolio focused on microsatellite instability as well as with Kura for specific mutations in head and neck tumors.

“We plan to launch TSO 500 as an [in vitro diagnostic test] this year in Europe and the U.S., making this important test available more broadly,” Illumina CEO Francis deSouza said at the annual J.P. Morgan healthcare conference.

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Meanwhile, the partnership with Myriad will feature time-limited exclusivity in certain markets to develop tests—by combining TruSight Oncology’s research with Myriad’s myChoice companion diagnostic—to check tumors for homologous recombination repair deficiency, or HRD, which could make them more susceptible to immunotherapies and PARP inhibitors.

“The agreement between Myriad and Illumina combines clinically validated companion diagnostics and next-generation sequencing to advance comprehensive genomic profiling of tumor samples and drive improved outcomes for oncology patients,” Myriad President and CEO Paul Diaz said in a statement. 

Finally, Illumina and Merck plan to conduct a study on the expanded TruSight Oncology HRD offering. No financial deals for any of the collaborations were disclosed.

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DeSouza also provided a peek at Illumina’s preliminary 2020 earnings reports. The company raised about $3.24 billion in estimated revenues for the full year—or about a 9% drop compared to 2019, with double-digit percentage drops during the second and third quarters due to the coronavirus pandemic. About $950 million was brought in during the fourth quarter as its businesses recovered.

More than $1.5 billion of the year’s total revenue came from its clinical genomics segment alone. Sequencing run rates exceeded pre-COVID-19 levels by the end of the year, and, with over 2,000 next-generation sequencing systems ordered in 2020 and the pending closure of the Grail deal, Illumina is estimating future revenue growth between 17% and 20% through 2021. Full 2020 results are expected in February.

Elsewhere, Grail confirmed that its multi-cancer blood test, Galleri, is set for U.S. commercial launch in the second quarter of this year. The company said it has completed enrollment of its final clinical study evaluating the laboratory-developed test in real-world practice after recruiting more than 134,000 participants for its research to date and raising over $2 billion in venture capital funding.