(b) Revenue for Q2 2024 included intercompany revenue of $9 million prior to the spin-off of GRAIL. Non-GAAP gross margin remained flat primarily due to higher freight and duties costs related to tariffs and an (c) increase in field service costs, partially offset by lower strategic partnership revenue, that is lower margin, and a more favorable product mix. The decrease in GAAP gross margin was primarily due to a $23 million impairment of an acquired intangible asset. SAN DIEGO, July 31, 2025 /PRNewswire/ ...

Core Insights - Illumina has expanded its clinical oncology portfolio to enhance access to precision oncology therapies through comprehensive genomic profiling solutions [1][2][3] Group 1: Product Offerings - The TSO Comprehensive test is the first FDA-approved distributable comprehensive genomic profiling IVD kit with pan-cancer CDx claims, evaluating both DNA and RNA [3][9] - The Pillar oncoReveal® CDx is a new addition to Illumina's IVD portfolio, designed for detecting genetic variations in 22 genes for patients with solid tumors [6][12] Group 2: Market Access and Reimbursement - TSO Comprehensive is now covered under Medicare plans by the Centers for Medicare & Medicaid Services (CMS) and most commercial health plans, facilitating broader access for patients [5][7] - The oncoReveal CDx has also received nationwide Medicare coverage, ensuring availability of next-generation sequencing testing for over 66 million people in the US [7][6] Group 3: Clinical Integration - Illumina's TSO Comprehensive is being integrated into clinical practices across various healthcare settings, including community oncology care practices and academic medical centers [3][4] - UofL Health – UofL Hospital is the first to offer the TSO Comprehensive test to patients, highlighting the growing adoption of this technology [3][4] Group 4: Regulatory Approvals - The TSO Comprehensive test has received regulatory approval in Japan, indicating the company's efforts to expand its market presence internationally [5] - The oncoReveal CDx is FDA approved for use on the Illumina MiSeq Dx System, further solidifying Illumina's position in the clinical diagnostics market [12]