About Illumina
Illumina, Inc. (Illumina) operates as a global leader in sequencing- and array-based solutions for genetic and genomic analysis. The company’s products and services serve customers in a wide range of markets, enabling the adoption of genomic solutions in research and clinical settings. The company’s customers include leading genomic research centers, academic institutions, government laboratories, and hospitals, as well as pharmaceutical, biotechnology, commercial molecular diagnostic laboratories, and consumer genomics companies. The company’s portfolio of integrated sequencing and microarray systems, consumables, and analysis tools is designed to accelerate and simplify genetic analysis. This portfolio addresses the range of genomic complexity, price points, and throughput, enabling customers to select the best solution for their research or clinical application. Segments The company has two reportable segments, Core Illumina and GRAIL. Core Illumina Core Illumina’s products and services serve customers in the research, clinical and applied markets; and enable the adoption of a variety of genomic solutions. Core Illumina includes all of the company’s operations, excluding the results of GRAIL. GRAIL GRAIL is a healthcare company focused on early detection of multiple cancers. Principal Markets The company sells its products to a number of customers outside the United States, including customers in other areas of North America, Latin America, Europe, China, and the Asia-Pacific region. The company targets the markets and customers outlined below. Research and Applied Historically, the company’s core business has been in the life sciences research market. This includes laboratories associated with universities, research centers, and government institutions, along with biotechnology and pharmaceutical companies. Researchers at these institutions use the company’s products and services for basic and translational research across a spectrum of scientific applications, including targeted, exome, and whole-genome sequencing; genetic variation; gene expression; epigenetics; and metagenomics. NGS technologies are being adopted due to their ability to sequence large sample sizes quickly and accurately, generating vast amounts of high-quality data. Both private and public funding drive this research, along with global initiatives to characterize genetic variation. The company’s products also serve various applied markets, including consumer genomics and agrigenomics. For example, in consumer genomics, the company’s customers use its technologies to provide personalized genetic data and analysis to individual consumers. In agrigenomics, government and corporate researchers use the company’s products and services to explore the genetic and biological basis for productivity and nutritional constitution in crops and livestock. Researchers can identify natural and novel genomic variation and deploy genome-wide marker-based applications to accelerate breeding and production of healthier and higher-yielding crops and livestock. Clinical The company is focused on enabling translational and clinical markets through the introduction of best-in-class sequencing technology. Further, the company is developing sample-to-answer solutions to catalyze adoption in the clinical setting, including in reproductive and genetic health and oncology. In reproductive health, the company’s primary focus is driving noninvasive prenatal testing (NIPT) adoption globally through the company’s technology, which identifies fetal chromosomal abnormalities by analyzing cell-free DNA in maternal blood. The company’s NGS technology is also accelerating rare and undiagnosed disease research to discover the genetic causes of inherited disorders by assessing many genes simultaneously. Using NGS can reduce costs compared to traditional methods of disease diagnosis, which are often expensive and inconclusive while requiring extensive testing. Customers in the translational and clinical oncology markets use the company’s products to perform research that may help identify individuals who are genetically predisposed to cancer and to identify molecular changes in a tumor. Circulating tumor DNA (ctDNA) will become an important clinical tool for managing oncology patients during all stages of tumor progression. The company’s technology is being used to research the implications of ctDNA in treatment determination, treatment monitoring, minimal residual disease, and asymptomatic screening. For example, GRAIL’s Galleri blood test for early-stage cancer detection is enabled by the company’s sequencing technology. Principal Products, Services, and Technologies The company’s unique technology platforms support the scale of experimentation necessary for population-scale studies, genome-wide discovery, target selection, and validation studies. Customers use the company’s products to analyze the genome at all levels of complexity, from targeted panels to whole-genome sequencing. A large and dynamic Illumina user community has published hundreds of thousands of customer-authored scientific papers using the company’s technologies. Through rapid innovation, the company is changing the economics of genetic research, enabling projects that were previously considered impossible, and supporting clinical advances towards precision medicine. Most of the company’s product sales consist of sequencing- and array-based instruments and consumables, which include reagents, flow cells, and library preparation, based on the company’s proprietary technologies. The company also performs various services for its customers. Sequencing The company’s portfolio of sequencing platforms represents a family of systems that set the standard for productivity and accuracy among NGS technologies. Customers use the company’s platforms to perform whole-genome, de novo, exome and RNA sequencing, and targeted resequencing of specific gene regions and genes. Understanding the similarities and differences in DNA sequence between and within species helps the company understand the function of the structures encoded in the DNA. The company’s DNA sequencing technology is based on its proprietary reversible terminator-based sequencing chemistry, referred to as sequencing by synthesis (SBS) biochemistry. SBS tracks the addition of labeled nucleotides as the DNA chain is copied in a massively parallel fashion. In 2023, the company launched XLEAP-SBS, a faster, higher quality, and more robust version of the company’s SBS chemistry that delivers the highest level of data accuracy and performance. The company’s XLEAP-SBS sequencing technology provides researchers with a broad range of applications and the ability to sequence more than 20,000 human genomes per year. The company’s sequencing platforms can generate between 500 megabases (Mb) and 16.0 terabases (Tb) (equivalent to approximately 128 human genomes) of genomic data in a single run, depending on the instrument and application. In 2023, the company launched the NovaSeq X Plus, the company’s new production-scale sequencing system. Illumina informatics products play a critical role in supporting the company’s sequencing applications and customers’ needs across a range of activities, including sample preparation, instrument control and management, and post-run analysis. The company’s BaseSpace Informatics Suite integrates directly with the company’s sequencing instruments, allowing customers to manage their biological sample and sequencing runs, process and analyze the raw genomic data, and derive meaningful results. It facilitates data sharing, provides data-storage solutions and streamlines analysis through a growing number of applications developed by the company and the bioinformatics community. The company’s DRAGEN Bio-IT Platform is used for secondary analysis and analyzes sequencing data from a variety of experiment types, including whole genomes, whole exomes, germline and somatic datasets, and RNA sequencing experiments with industry leading accuracy, speed and efficiency. Additionally, Illumina Connected Analytics is an integrated bioinformatics solution that provides a comprehensive, private, cloud-based data platform that empowers customers to manage, analyze, and explore large volumes of multi-omic data in a secure, scalable, and flexible environment. Arrays The company’s BeadArray technology combines microscopic beads and a substrate in a proprietary manufacturing process to produce arrays that can perform many assays simultaneously. This facilitates large-scale analysis of genetic variation and biological function in a unique, high-throughput, cost-effective, and flexible manner. Using the company’s BeadArray technology, the company achieves high-throughput analysis via a high density of test sites per array and the ability to format arrays in various configurations. To serve the needs of multiple markets and market segments, the company can vary the size, shape, and format of the substrate into which the beads self-assemble and create specific bead types for different applications. The company’s iScan System and its NextSeq 550 System can be used to image arrays. Consumables The company has developed various library preparation and sequencing kits to simplify workflows and accelerate analysis. The company’s sequencing applications include whole-genome sequencing kits, which sequence entire genomes of any size and complexity, and targeted resequencing kits, which can sequence exomes, specific genes, RNA or other genomic regions of interest. The company’s sequencing kits maximize the ability of its customers to characterize the target genome accurately and are sold in various configurations, addressing a wide range of applications. Customers use the company’s array-based genotyping consumables for a wide range of analyses, including diverse species, disease-related mutations, and genetic characteristics associated with cancer. Customers can select from a range of human, animal, and agriculturally relevant genome panels or create their own custom arrays to investigate millions of genetic markers targeting any species. Services The company offers support services to customers who have purchased its products. In addition, the company provides whole-genome sequencing, genotyping, NIPT, and product support services. Human whole-genome sequencing services are provided through the company’s CLIA-certified, CAP-accredited laboratory. Using the company’s services, customers can perform whole-genome sequencing projects and microarray projects (including large-scale genotyping studies and whole-genome association studies). The company also provides NIPT services through its partner laboratories that direct samples to the company on a test send-out basis in its CLIA-certified, CAP-accredited laboratory. GRAIL GRAIL’s multi-cancer early detection test, Galleri, is designed as a screening test for adults with an elevated risk for cancer, such as those aged 50 or older, and was commercially launched in 2021 as a laboratory developed test. In addition to Galleri, GRAIL is developing solutions to help accelerate cancer diagnoses, blood-based detection for minimal residual disease, and other post-diagnostic applications. Intellectual Property As of January 2, 2024, excluding GRAIL, the company owned or had exclusive licenses to 1,243 issued U.S. patents and 1,101 pending U.S. patent applications and an additional 8,650 issued patents outside the U.S. and 5,947 pending patent applications outside the U.S. The company’s issued and pending patents cover various aspects of the company’s arrays, assays, oligo synthesis, sequencing technology, instruments, digital microfluidics, software, bioinformatics, and chemical-detection technologies, and the company’s issued patents have terms that expire between 2024 and 2048. GRAIL owns certain patent applications and intellectual property and exclusively licenses certain patents, patent applications, and other intellectual property from third parties. GRAIL’s patent portfolio broadly relates to methods, techniques and chemistry used to generate and analyze data using its proprietary bioinformatics and classifiers, including for example, cfNA sequencing, marker panels, methylation signatures, bioinformatics techniques and biologically directed machine learning classifiers, which are incorporated into GRAIL’s products. As of January 2, 2024, GRAIL had exclusive licenses to more than 550 issued or granted patents and more than 830 pending patent applications globally, including more than 80 issued U.S. patents. GRAIL also owned or co-owned more than 620 pending patent applications globally, including more than 190 pending U.S. non-provisional and provisional patent applications. GRAIL’s patent portfolio includes patents and patent applications related to sequencing, library preparation and enrichment, marker panels, methylation profiling, and bioinformatic techniques and classifiers. GRAIL’s licensed patents are expected to begin expiring in 2027. The patents that GRAIL owns or co-owns, are expected to begin expiring in 2037. Research and Development The company’s research and development expenses were $1,354 million in 2023. Marketing and Distribution The company markets and distributes its products directly to customers in North America, Europe, Latin America, and the Asia-Pacific region. In addition, the company sells through life-science distributors in certain markets within Europe, the Asia-Pacific region, Latin America, the Middle East, and Africa. Trademarks Assign, BaseSpace, BeadArray, Bluebee, BlueFuse, BlueGnome, cBot, Clarity LIMS, CircLigase, COVIDSeq, DesignStudio, DRAGEN, DRAGEN ORA, Emedgene, Enancio, FastTrack, Flow, Genetic Energy, GenomeStudio, Genomics Suite, Golden Gate, HiSeq, iHope, Illumina, Illumina Connected Analytics, Illumina Propel Certified, Infinium, iScan, iSelect, iSeq, MiniSeq, MiSeq, MiSeq FGx, Nextera, NextSeq, NovaSeq, Partek, Pattern Visualization System, Powered by Illumina, Praxis, Ribo-Zero, SureCell, The Analytical Spreadsheet, TruGenome, TruSeq, TruSight, Turning Data Into Discovery, Verifi, Verinata, Verinata Health, VeriSeq, XLEAP-SBS, the pumpkin orange color, and the Genetic Energy / streaming bases design are trademarks or registered trademarks of Illumina. ‘GRAIL,’ the GRAIL logos, and other trade names, trademarks, or service marks of GRAIL are the property of GRAIL. The ‘Galleri’ mark and logo are registered in numerous countries, including the United States and the United Kingdom. Applications to register the ‘Galleri’ mark and logo, the ‘GRAIL’ mark and the logo, and marks associated with GRAIL are also pending in a variety of countries. Government Regulation The company’s products sold as medical devices or IVDs in Europe are now regulated under the In Vitro Diagnostics Regulation (EU) 2017/746, the IVDR, that went into full enforcement in May 2022. These regulations include requirements for both presentation and review of performance data and quality-system requirements. Certain of the company’s products are available through laboratories that are certified under the Clinical Laboratory Improvements Amendments (CLIA) of 1988. These products are commonly called ‘laboratory developed tests,’ or LDTs. CLIA also mandates that, for high complexity labs, such as the company, to operate as a lab, the company must have an accreditation by an organization recognized by CLIA, such as the College of Pathologists (CAP), which the company has obtained and must maintain. History Illumina, Inc. was founded in 1998. The company was incorporated in California in 1998 and reincorporated in Delaware in 2000.
