The court cited previous US Supreme Court rulings, including Mayo vs. Prometheus, in determining that certain claims of Illumina's patents were invalid.
The immunohistochemistry-based CDx will operate on the Roche BenchMark ULTRA instrument.
By achieving certification for the assay, called PredictSure IBD, the Cambridge, UK-based firm can sell it for clinical use across Europe.
The CDx, which will include the detection of activating FGFR2 fusions, is expected to be incorporated into Foundation Medicine's FDA-approved FoundationOne CDx assay.
Roche will develop an immunohistochemistry-based companion diagnostic for Daiichi's investigational HER2-targeting antibody conjugate for breast cancer.
While the first task of the centers will be to digitize their workflows to improve efficiency, they also aim to eventually develop new AI-based analytical tools for diagnosing patients.
The platform is currently used by pathologists doing research and could be available in a year for primary diagnosis of cancers in clinical settings.
The recall affects certain lot numbers and package sizes that were manufactured and distributed between January 12 and October 29 of this year and involves more than 1.1 million packages.
The consulting practice will advise labs on issues such as technology, process improvements, and workforce management. It expects to launch in the US next year.
Roche Diagnostics' revenues were driven by its centralized and point-of-care solutions as well as its tissue diagnostics business, both rising in the high-single digits.