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Illumina, Geneseeq Technology to Collaborate on IVD Cancer Testing Kits in China

NEW YORK – Illumina and Geneseeq Technology said on Tuesday that they are collaborating on next-generation sequencing-based in vitro diagnostic testing kits for cancer profiling in China.

Geneseeq will develop kits for Illumina's NextSeq 550Dx platform based on GeneseeqPrime, a comprehensive genomic profiling panel that analyzes alterations in 425 cancer-related genes and assesses tumor mutational burden (TMB) and microsatellite instability.

Under the terms of the deal, Geneseeq will conduct all studies in order to develop and commercialize the kits, while Illumina will provide IVD instruments and components. The new tests will be made available directly to patients through Geneseeq, as well as at hospital testing centers. Financial and other details were not disclosed.

Geneseeq, founded in Toronto with additional headquarters in Nanjing, China, develops NGS-based cancer tests. In December 2019, Geneseeq closed an RMB 800 million ($114 million) Series D financing round led by China Reform Holdings — a Chinese government-backed investment fund — and joined by Lilly Asia Ventures and SoftBank China Venture Capital, among others.

The deal expands on a partnership between Geneseeq and Illumina to accelerate clinical availability of NGS testing in precision cancer care. In 2018, the two firms began seeking approval from China's National Medical Products Administration (NMPA) for Essencare, an EGFR, ALK, ROS1, BRAF, KRAS, and HER2 mutation test for non-small cell lung cancer.

NMPA approved the NextSeq 550Dx for use in genetic testing and diagnosis in December 2020 after approving the Illumina MiSeqDx for clinical use in 2018.

Illumina has also partnered with Chinese molecular diagnostics firms Burning Rock Dx and AnchorDx to develop clinical cancer tests in China.

"We're pleased to extend our collaboration with Geneseeq to develop assays based on the newly approved NextSeq 550Dx in China," said Li Qing, VP and general manager of Greater China at Illumina, in a statement. "Together with partners such as Geneseeq, we are able to continuously bring in innovative NGS testing products to patients in China, and ultimately help them by unlocking the power of the genome."