Illumina Inc Stock Price, News & Analysis

QIAGEN (QGEN) and Incyte (INCY) have announced a global collaboration to develop a novel diagnostic panel for myeloproliferative neoplasms (MPNs). The partnership focuses on creating a multimodal panel using next-generation sequencing technology to detect gene alterations in blood cancers, particularly targeting mutant calreticulin (mutCALR). The panel will support Incyte's drug portfolio, including INCA033989, and will be validated on Illumina's NextSeq 550Dx platform. QIAGEN will handle regulatory submissions and market access across the US, EU, and Asia-Pacific regions. The collaboration aims to improve treatment decisions for MPN patients, which represent about 40% of hematological malignancies, by enabling precise identification of genomic aberrations in biomarkers like CALR.

Illumina (NASDAQ: ILMN) has released its 2024 Corporate Social Responsibility Report, highlighting significant achievements in genomics accessibility and sustainability. The company expanded healthcare coverage for genomic testing to an additional 100 million people, reaching 1.4 billion lives covered. Notable sustainability achievements include an 80% reduction in packaging since 2019, exceeding their 2030 target, and maintaining 100% renewable electricity usage globally. The new MiSeq i100 Series launch demonstrated a 35% reduction in climate impact. Illumina reached 2.1 million STEM learners since 2019, maintained zero net pay gap for six years, and achieved a 45% decrease in scope 1 and 2 emissions from 2019. Employee engagement showed strong results with 52% participation in giving programs and over 91,000 volunteer hours contributed.

Illumina (NASDAQ: ILMN) has unveiled PromoterAI, a groundbreaking AI algorithm that accurately identifies pathogenic regulatory genetic variants in noncoding regions of the human genome. According to a study published in Science, this technology discovered regulatory variants in promoter segments that contribute up to 6% of genetic causes of rare diseases.

PromoterAI analyzes noncoding promoter regions, which are crucial for gene transcription and comprise over 98% of the genome. When combined with whole-genome sequencing (WGS), this AI tool could improve rare disease diagnosis rates, which currently stand at only 30% with exome sequencing. The algorithm, together with Illumina's other AI tools (PrimateAI-3D and SpliceAI), effectively doubles the diagnostic yield compared to using protein-truncating variants alone.

The technology is now available through Illumina Connected Software and DRAGEN™ secondary analysis, with precomputed scores freely available for academic and noncommercial research.

Illumina (NASDAQ: ILMN) announced an expansion of its clinical oncology portfolio with two key developments. First, their TruSight™ (TSO) Comprehensive test, the first FDA-approved distributable comprehensive genomic profiling IVD kit with pan-cancer CDx claims, has gained broad payer reimbursement including Medicare and most commercial health plans. UofL Health became the first customer to implement the test. The test has also received regulatory approval in Japan.

Second, Illumina partnered with Pillar Biosciences to offer Pillar oncoReveal CDx, an IVD kit for detecting genetic variations in 22 genes for solid tumor patients. The test recently received nationwide Medicare coverage, making it accessible to over 66 million Medicare beneficiaries in the US.

Illumina (NASDAQ: ILMN) has announced its participation in the upcoming 41st Annual Bernstein Strategic Decisions Conference. The company's executives will engage in a fireside chat on May 28, 2025, at 11:30 AM Pacific Time (2:30 PM Eastern Time). Investors and interested parties can access the webcast through the Investor Info section on investor.illumina.com. A replay of the presentation will be available on the company's website for a minimum of 30 days following the event.

Illumina (NASDAQ: ILMN) has launched DRAGEN v4.4, an enhanced secondary analysis software solution featuring significant improvements in accuracy and functionality. Key highlights include a 30% improvement in structural variant calling accuracy and a 20% boost in SNV and indel calling accuracy. The update introduces preconfigured oncology applications for clinical research, enhanced multiomics pipelines, and AWS F2 support for faster processing. The University Hospital of Tübingen has selected DRAGEN for a pioneering study to evaluate clinical utility in whole-genome germline testing. The software's new features include push-button analysis for oncology workflows, support for new multiomics assays, and improved cloud analysis capabilities. This release builds on DRAGEN's established leadership in variant calling accuracy, as validated in a peer-reviewed Nature Biotechnology study from October 2024.

Illumina (ILMN) reported Q1 2025 financial results with core revenue of $1.04 billion, down 1% year-over-year. The company posted GAAP operating margin of 15.8% and non-GAAP operating margin of 20.4%. Q1 GAAP diluted EPS was $0.82, while non-GAAP diluted EPS reached $0.97. Cash flow from operations was $240 million with free cash flow of $208 million. The company revised its FY2025 guidance downward, now expecting core revenue to decline 1-3% on a constant currency basis. Revenue outside Greater China is projected to grow 0-2%, while Greater China revenue is expected at $165-185 million. The company faces $85 million in tariff-related costs, impacting operating margin by 125 bps and EPS by $0.25. Non-GAAP operating margin guidance was lowered to 21.5-22.0% from 23%, with EPS guidance reduced to $4.20-4.30 from $4.50.

Illumina and Ovation.io are launching a groundbreaking dataset featuring integrated clinical and multiomic insights from 25,000 patients treated with GLP-1 therapies. The collaboration aims to advance drug discovery and development in the pharmaceutical industry. Key highlights include:

The dataset will be the largest commercially available clinical multiomic dataset for GLP-1 therapies, incorporating whole-genome sequencing and protein expression profiling of 5,000 samples using Illumina's IPP assay that detects 9,500 human proteins per sample.

This initiative addresses significant market needs, as 1 in 8 adults in the US use GLP-1 receptor agonists, but approximately 40% of Type 2 diabetes patients don't respond effectively to these treatments. The dataset will help identify new indications, biomarkers, and drug targets, particularly for non-responsive patients.

Illumina (NASDAQ: ILMN) and Tempus AI (NASDAQ: TEM) have announced a strategic collaboration to accelerate the clinical adoption of next-generation sequencing tests through AI-driven innovation. The partnership aims to combine Illumina's AI technologies with Tempus's multimodal data platform to enhance genomic algorithms and expand molecular profiling across various disease categories.

The collaboration focuses on developing evidence to standardize comprehensive genomic profiling and molecular testing beyond cancer, extending to cardiology, neurology, and immunology. This builds upon the companies' existing partnership in developing tools and assays for testing needs from preemptive screening through therapy selection.

The initiative addresses the current gap where patients often miss precision medicine benefits due to non-standardized molecular profiling across disease areas and regions. The partnership will leverage data analytics and sequencing technologies to improve patient outcomes and advance precision medicine research.