F. Hoffmann-La Roche Ltd
Roche is a leading global biotechnology and diagnostics company based in Basel, Switzerland, and is consistently ranked as a top player, emerging as the market leader in 2023. With a strong focus on research-driven pharmaceuticals and diagnostics, Roche’s commitment to high-throughput, reliable, and automated sample analysis is largely enabled by its robust companion diagnostics (CDx) platforms. These systems are critical for processing large volumes of patient samples quickly and accurately, supporting personalized diagnostics and therapeutic monitoring in modern healthcare. The company’s strategic use of CDx demonstrates the technology’s impact in routine clinical practice, making complex molecular and immunological testing faster and more accessible. Notable contributions include the FDA-approved VENTANA Assay, which is an immunohistochemistry (IHC) CDx for assessing CLDN18 protein expression in gastric cancer, and the cobas EGFR Mutation Test v2 for Non-Small Cell Lung Cancer (NSCLC). Furthermore, its subsidiary, Foundation Medicine, offers comprehensive genomic profiling tests.
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Abbott Laboratories
Abbott Laboratories is a prominent global healthcare company specializing in healthcare products and medical devices, with a significant molecular diagnostics division in the US. Abbott actively integrates microfluidics into its diagnostic platforms, which is essential for rapid, reliable, and user-friendly medical testing with minimal sample volumes. In the companion diagnostics (CDx) field, the company’s Abbott Molecular, Inc. subsidiary has developed key FDA-approved assays. Examples include the Vysis CLL FISH Probe Kit, which diagnoses B-cell Chronic Lymphocytic Leukemia and guides treatment selection for Venclexta based on the deletion of chromosome 17p, and the Vysis ALK Break Apart FISH Probe Kit, which detects ALK gene rearrangements for NSCLC treatments like Xalkori and Alunbrig. This focus on precision and automation through CDx solidifies Abbott’s role in advancing personalized healthcare solutions globally.
Agilent Technologies, Inc.
Agilent Technologies, Inc. is a global leader in analytical instrumentation and laboratory systems that centers its strategy on integrating advanced microfluidics across its renowned platforms. As a top CDx company, Agilent provides comprehensive offerings, including specialized microfluidic chips, precision reagents, and consumables for various analytical assays, with the goal of achieving higher throughput and precise sample handling. A significant part of its CDx expertise comes from its subsidiary, Dako (based in Denmark), which specializes in companion diagnostics for targeted therapy and cancer immunotherapy. By developing reliable, high-performance CDx tools and continually supporting scientific advancements with its robust laboratory infrastructure, Agilent Technologies plays a pivotal role in empowering researchers and clinicians to utilize precision medicine in cancer treatment.
QIAGEN
QIAGEN, headquartered in the Netherlands, is a key market player in molecular diagnostics and is consistently ranked among the top companies in the companion diagnostics (CDx) market. The company’s expertise lies in developing essential sample preparation and assay technologies, which are foundational to creating precise and highly reliable CDx tests. QIAGEN’s comprehensive portfolio of molecular diagnostic solutions is integral to personalized medicine, supporting the identification of crucial biomarkers. They assist pharmaceutical companies in designing and validating diagnostic tests that guide therapeutic decisions in oncology and other complex diseases. Their leading position is secured by their commitment to advancing the use of molecular diagnostics and providing the necessary technology to translate genetic findings into actionable clinical results.
Thermo Fisher Scientific, Inc.
Thermo Fisher Scientific, Inc. is a globally renowned leader in scientific solutions, specialized diagnostics, and laboratory services in the US. The company significantly contributes to the companion diagnostics (CDx) market by providing a diverse and critical infrastructure of high-throughput systems and advanced analytical equipment. Its microfluidics capabilities are a core enabler, extending to specialized array plate technology for digital PCR, which is vital for highly accurate quantification in research. Furthermore, their expansive product line includes solutions for life sciences and clinical diagnostics, enabling researchers and clinicians to accelerate drug discovery and diagnostics development. By integrating sophisticated technology, Thermo Fisher ensures the delivery of essential scientific solutions that support the identification of biomarkers and the development of targeted therapies.
Danaher Corporation
Danaher Corporation is a diversified global science and technology conglomerate that is consistently ranked as a leading player in the companion diagnostics (CDx) market, primarily through its life sciences and diagnostics segments, which include brands like Beckman Coulter. The company actively drives the adoption of CDx technologies through internal innovations and strategic acquisitions, providing integrated, automated solutions essential for complex laboratory workflows. Danaher’s diversified portfolio encompasses advanced diagnostic testing systems and sophisticated lab analytics tools. This strong capability enables the company to deliver reliable and reproducible results in critical areas like genomics and molecular diagnostics. By focusing on seamlessly integrating CDx components into automated systems, Danaher provides the necessary technological backbone for next-generation precision medicine globally.
Illumina, Inc.
Illumina, Inc. is a technological powerhouse recognized globally as a leader in DNA sequencing and array-based technologies, where microfluidics serves as a core enabling technology. The company’s market-leading sequencing platforms, such as the HiSeq, NovaSeq, and MiSeq series, fundamentally rely on integrated microfluidic chips to enable swift, high-throughput, and highly precise DNA sequencing. This next-generation sequencing (NGS) is a core technology for developing and deploying modern companion diagnostics (CDx). Illumina’s continuous development of user-friendly and sophisticated sequencing solutions maintains a transformative impact on both academic genomics research and clinical diagnostics worldwide, making complex genetic analysis more accessible and scalable for diverse laboratory settings globally, thereby supporting CDx discovery and validation.
bioMérieux
bioMérieux, a global leader in in vitro diagnostics (IVD) based in France, is a significant company in the companion diagnostics (CDx) market. Founded in 1963, the company develops innovative tests for the diagnosis of infectious diseases and the monitoring of therapies. bioMérieux’s strong focus on IVD solutions is directly leveraged in the CDx field, where its products are designed to accelerate and enhance decision-making in patient care. By providing accurate and timely diagnostic information, bioMérieux supports pharmaceutical partners in the development and delivery of targeted therapies. The company’s commitment to improving global health is reflected in its role in helping clinicians determine which patients will benefit most from a specific drug, thereby promoting personalized medicine.
Myriad Genetics, Inc.
Myriad Genetics, Inc., a US-based company, is a recognized player in the companion diagnostics (CDx) market, specializing in molecular diagnostic assays for hereditary cancer risk assessment and personalized therapy selection. The company’s portfolio includes molecular diagnostic assays, gene expression profiling tests, and multigene panel tests. These products are crucial for identifying specific genetic mutations and guiding treatment decisions in oncology. By delivering these specialized diagnostic tools, Myriad Genetics provides clinicians with the essential information to select the most appropriate therapeutic path for cancer patients based on their unique genetic profile, which is a core tenet of personalized medicine.
Foundation Medicine, Inc.
Foundation Medicine, Inc., a member of the Roche Group based in the United States, is a key manufacturer of companion diagnostics (CDx) that focuses on comprehensive genomic profiling (CGP) for cancer. Their flagship products, such as FoundationOne CDx and FoundationOne Liquid CDx, are FDA-approved diagnostic assays that analyze a patient’s tumor tissue or plasma to identify specific genetic alterations. These alterations include EGFR exon 19 deletions or BRAF V600E mutations, and the test indications explicitly link these findings to suitability for treatment with specific targeted therapies like tyrosine kinase inhibitors and BRAF/MEK Inhibitor Combinations. This makes Foundation Medicine an indispensable partner in the development and delivery of precision oncology.
Labcorp
Labcorp is a global life science company that plays a crucial role in the companion diagnostics (CDx) market by providing drug development and diagnostic testing services. The company’s CDx services are offered through its Contract Research Organization (CRO) business, Labcorp Drug Development (formed after acquiring Covance), which assists pharmaceutical firms in designing and validating diagnostic tests. Labcorp possesses expertise in developing both in vitro diagnostic tests (IVD) and laboratory developed tests (LDTs) in harmony with a sponsor company’s drug development programs. The firm has a significant track record, claiming to have supported 19 of the 25 FDA-approved CDx devices targeting key biomarkers like HER-2, KRAS, and EGFR, making it a major service provider in the industry.
Eurofins Scientific
Eurofins Scientific, headquartered in Luxembourg, is listed as a top companion diagnostics (CDx) development company, utilizing its extensive network of laboratories to provide analytical testing services. The company is known for its expertise in safety and quality control across multiple sectors, including pharmaceuticals. This strong foundation is leveraged to provide essential services to pharmaceutical firms, assisting them in the design, validation, and regulatory compliance of their CDx tests. The company’s Diagnostic Services and Products segment is a key contributor to its overall revenue, and its role as a service provider is critical in helping clients bring companion diagnostic products to market, as evidenced by its involvement in a CDx approved in 2024 for a Pfizer gene therapy.
Siemens Healthineers
Siemens Healthineers is a German healthcare technology company that provides a wide range of healthcare equipment, solutions, and services globally, with a focus on imaging, diagnostics, cancer care, and minimally invasive therapies. As one of the world’s largest diagnostic companies, Siemens Healthineers plays a substantial role in the companion diagnostics (CDx) market. While specific CDx product lines are not detailed, the company’s vast diagnostic infrastructure and commitment to precision diagnosis and oncology solutions are essential for the widespread implementation of CDx in clinical settings. Their technological solutions are vital for advancing modern healthcare delivery and supporting targeted therapy strategies.
Quest Diagnostics
Quest Diagnostics is a leading US-based provider of diagnostic information services, offering a range of tests from routine biological assays to specialized molecular and gene-based tests. Quest is a top companion diagnostics (CDx) development company, providing drug development solutions to pharmaceutical companies and Contract Research Organizations (CROs). The company’s portfolio includes precision medicine, diagnostics development, and data analytics. Quest’s ability to develop CDx tests for clients is greatly enhanced by its massive repository of over 60 billion clinical data points, gathered over 15 years. This extensive network and data capability establish Quest as a major force in the development and delivery of diagnostic services necessary for personalized medicine.
Tempus Labs, Inc.
Tempus Labs, Inc. is a company that provides advanced diagnostic tests, utilizing next-generation sequencing, for cancer patients. Tempus is the manufacturer of the xT CDx assay, an FDA-approved companion diagnostic that is used for Colorectal Cancer (CRC). This diagnostic test analyzes tissue and matching blood/saliva samples to identify patients with *KRAS* and *NRAS* wild-type tumors, which are then suitable for treatment with specific targeted therapies, such as Erbitux (cetuximab) and Vectibix (panitumumab). The use of the xT CDx assay, which matches tissue and liquid biopsy samples, highlights the company’s role in applying cutting-edge diagnostic technology to personalize treatment decisions in oncology.
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