With genetic sequencing at the forefront of precision medicine, Illumina announced a portfolio of new and expanded oncology partnerships that further the company's commitment to develop standardized, globally distributable tools for precision oncology. TruSight Oncology 500 (TSO 500) is a Research Use Only comprehensive pan-cancer assay designed to identify 523 known and emerging tumor biomarkers. TSO 500 utilizes both DNA and RNA from tumor samples to identify key somatic variants critical for cancer development and progression, such as small DNA variants, fusions, and splice variants.

Based on the content of TSO 500, Illumina will be adding an in vitro diagnostic (IVD) test to the TruSight Oncology product family. This comprehensive tumor profiling assay will have similar chemistry and analytics to TSO 500 and is currently undergoing review with regulatory authorities. It is expected to be launched in both the U.S. and Europe later this year.

Illumina is leveraging the content of its TSO 500 assay to develop companion diagnostics (CDx). The following partnerships demonstrate Illumina's commitment to collaborating with industry leaders on cancer diagnostics and the advancement of precision oncology: BRISTOL MYERS SQUIBB: Expanding on a collaboration that began in 2018, Bristol Myers Squibb will develop a microsatellite instability CDx, as well as develop a diagnostic based on the content of TruSight Oncology 500 ctDNA, Illumina's first liquid biopsy assay. Both program expansions are planned for global use by Bristol Myers Squibb's portfolio of cancer therapeutics.

KURA ONCOLOGY: Our partnership with Kura Oncology is focused on building a CDx claim for HRAS mutations in Head and Neck Squamous Cell Carcinomas. Responding to the growing clinical use of PARP inhibitor drugs beyond BRCA-mutant cancers, and toward broader populations of patients with homologous recombination repair deficiency (HRD), Illumina is partnering to further expand the clinical utility of the TruSight Oncology portfolio. MYRIAD GENETICS: Illumina is partnering with Myriad, with time-limited exclusivity in certain markets, to develop and commercialize distributed kits for the assessment of HRD and for Myriad to expand its HRD service offerings, through a combination of TruSight Oncology content and Myriad's myChoice® CDx test.

MERCK: Additionally, Illumina and Merck are conducting a study focused on the expanded TruSight Oncology HRD offering.