On September 11, 2026, Clinical Genomics Pty Ltd, Clinical Genomics Technologies Pty Ltd, and Clinical Genomics, Inc. filed a complaint against GRAIL, Inc. in Clinical Genomics Pty Ltd et al. v. GRAIL, Inc., No. 1:26-cv-01147 (D. Del.), ECF No. 1. This summary describes that complaint.
Patents and accused products
The complaint asserts U.S. Patent 10,590,468, titled Method for methylation analysis, and U.S. Patent 10,941,449, titled Method of screening for colorectal cancer. The accused product is Grail's Galleri test, which analyzes methylation patterns of cell-free DNA (cfDNA).
What the patents cover
U.S. Patents 10,590,468 and 10,941,449 cover laboratory methods that look at DNA methylation patterns in blood-derived DNA to screen for cancer. The '468 patent focuses on methylation analysis methods; the '449 patent focuses on colorectal-cancer screening using methylation markers.
U.S. Patent 10,590,468 covers assessing nucleic acid methylation - in particular cytosine methylation of partially methylated DNA or RNA - with improved sensitivity, for diagnosing conditions or monitoring developmental phenotypes marked by methylation changes.
Asserted claims of the '468 patent. Paragraph 84 identifies claim 1 among the claims allegedly infringed by the Galleri test.
Claim 1 covers detecting cytosine methylation by modifying unmethylated cytosines, then in one reaction measuring partially methylated regions with primers and probes that can hybridize to more than one methylation pattern at that region, and amplifying the sample.
U.S. Patent 10,941,449 covers determining probabilities that a large-intestine neoplasm falls into categories such as adenoma or stages I-IV by screening methylation levels of markers including BCAT1, IKZF1, IRF4, GRASP, and/or CAHM, for colorectal neoplasm diagnosis and monitoring.
Asserted claims of the '449 patent. Paragraph 92 identifies claim 1 among the claims allegedly infringed by the Galleri test.
Claim 1 covers measuring methylation of a DNA region from a blood-derived sample of someone known or suspected to have a large-intestine neoplasm: extract circulating cell-free DNA, bisulfite-convert it, and detect methylation with methylation-specific primers.
What the lawsuit is about
Clinical Genomics contends that Galleri's cfDNA methylation workflow practices the claimed screening and analysis methods. The case sits at the intersection of multi-cancer early detection products and method patents on methylation assays.
Scope of this summary
The allegations summarized here come from the September 11 complaint, including the description of Galleri in paragraphs 72-73 and the infringement allegations in paragraphs 84 and 92. They are allegations by Clinical Genomics, not findings by the court.