Top 5 CDx Development Companies

Over the years, companion diagnostics have become increasingly important as they serve multiple functions, such as identifying individuals most likely to profit from a specific therapeutic product, detecting those at elevated risk for severe side effects caused by treatment and tracking treatment responses to optimize safety and effectiveness. We analyzed over 155 CDx development companies that are engaged in offering end-to-end CDx development services. In this article, discover top 5 CDx development companies and their capabilities in supporting companion diagnostics development.

A companion diagnostic is a type of in-vitro diagnostic (IVD) device / test that is capable of providing crucial information for the safe and efficient use of a compatible drug or biological product. The development of such tests is a long process, starting from the identification of a suitable biomarker (specific to a particular disease indication) to validation of an accurate means to investigate / quantify its presence in biological samples. The aforementioned process involves the participation of multiple stakeholders, including drug developers, in vitro diagnostics developers, regulatory authorities, testing laboratories, payers, physicians and end-users / consumers / patients. Given the complexities involved in the development of such diagnostic tests, drug developers prefer outsourcing this process to contract service providers having the necessary expertise. Presently, numerous companies claim to offer a variety of services for diagnostic development, including biomarker identification and discovery, biomarker selection and validation, assay development, analytical validation, clinical validation, commercialization, manufacturing, services related to companion diagnostic kits, reagent development and regulatory assistance.

Roots Analysis has conducted an exhaustive study on Companion Diagnostics (CDx) Development Market featuring the current market landscape and future opportunity for the companies engaged in offering end-to-end services related to CDx development, over a span of 11 years.

Table of Contents

Below, we have listed (in alphabetical order), the top 5 CDx Development Companies:

1. BGI Genomics
2. Eurofins
3. Labcorp
4. Q2 Solutions
5. Quest Diagnostics

Interested in exploring all 155+ CDx Development Companies and their recent initiatives?

Discover Below the Details on Top 5 CDx Development Companies 

Let us deep dive to understand the activity of the top 5 CDx development companies (companies having service portfolio strength score above 21, 20 and 14 on Roots Analysis proprietary matrix and headquartered in North America, Europe and Asia-Pacific, respectively) in the companion diagnostics (CDx) development market. It is essential to note that the selection of top players can differ substantially according to the defined criteria.

In April 2024, BGI Genomics Established a New Clinical Laboratory at Uruguay, Utilizing Advanced Technology to Facilitate Early Disease Diagnosis

1. BGI Genomics

BGI Genomics, is an integral part of BGI Group. It is primarily a genome sequencing service provider established to support the Human Genome Project. It offers integrated genomic sequencing and proteomics services to academic institutions, pharmaceutical companies, healthcare providers and other organizations, across 100 countries. Using its proprietary DNA Nanoball based sequencing (DNBseq) technology, the company is actively serving projects for various applications, such as clinical research in human health, genetic testing and screening, drug discovery and development, and personalized medicine. To date, it claims to have completed over 150,000 human whole genome sequencing projects. 

BGI Genomics: Company Overview

Key Parameters	Description
Company Logo
Year of Establisment	1999
Number of Employees	5,001-10,000
Headquarters	Shenzhen, China

BGI Genomics has been actively expanding its reach and capabilities in companion diagnostic development services. The company has collaborated with Gencove to co-market cutting-edge NGS-based sequencing technology alongside advanced analysis platforms, showcasing a commitment to innovation and precision in healthcare solutions. With a focus on infectious disease diagnostic solutions and a growing portfolio, BGI is at the forefront of developing advanced diagnostic tools for public health.

Further details on recent initiatives taken by BGI Genomics and other CDx development companies have been provided in detail in the report.

In Q1 2024, Eurofins’s Diagnostic Services and Products Segment Represented About 20% of the Company’s Total Revenues  

2. Eurofins

Eurofins company caters to the need of a wide variety of industries, including food, environment, pharmaceutical, cosmetic product testing, discovery pharmacology, clinical studies, as well as biologics contract manufacturing. The company offers services for the development of companion and complementary diagnostics, through its Clinical Diagnostics Services portfolio. With over 400,000 m2 dedicated analytical laboratories, it offers services ranging from discovery to commercialization of companion diagnostics to its clients, including the top ten global pharmaceutical companies. In addition to its projects associated with oncological indications, it is involved in handling diagnostics projects involving innovative therapies for rare diseases.

Eurofins: Company Details

Particulars	Specifications
Company Logo
Year of Establisment	1987
Number of Employees	10,000+
Headquarters	Luxembourg City, Luxembourg

In 2022, the company enhanced its clinical and BioPharma services in Japan through the acquisition of Repertoire Genesis, which provides immune repertoire analysis technology. This strategic move allows Eurofins to strengthen its capabilities in immune-related translational research, biomarker development, diagnostics and pharmaceutical advancement from discovery to clinical trials.

Further details on recent initiatives taken by Eurofins and other CDx development companies have been provided in detail in the report.

In April 2024, a Companion Diagnostic Developed by Labcorp Received FDA Approval for Use with Pfizer’s Gene Therapy Beqvez

3. Labcorp

Labcorp is a global life science company which provides diagnostic testing, drug development and technology-enabled solutions through its Labcorp Diagnostics (Dx) and Labcorp Drug Development (DD) segments. Its CRO business, through which it offers companion diagnostics services is Labcorp Drug Development; the segment was formed after Labcorp acquired Covance. The company has expertise in the development of in vitro diagnostic tests (IVD) and laboratory developed tests (LDT), in harmony with the sponsor company’s drug development programs. The firm claims to have supported 19 of the 25 FDA approved companion diagnostic devices, including those targeting HER-2, KRAS, EGFR, BRAF and ALK. Furthermore, the company has also supported the development of the first two FDA-approved complementary diagnostics.

Labcorp: Company Overview

Particulars	Specifications
Company Logo
Year of Establisment	1978
Number of Employees	10,000+
Headquarters	North Carolina, US

In November 2023, Labcorp acquired Legacy Health’s assets of outreach laboratory business and thereby strengthening its diagnostic capabilities and comprehensive laboratory services in Oregon and Southwest Washington. 

Further details on recent initiatives taken by Labcorp and other CDx development companies have been provided in detail in the report.

Q² Solutions Strengthened Next Generation Sequencing Approaches With Illumina’s NovaSeq™ X Plus Platform Solution

4. Q2 Solutions 

Q2 Solutions is a global laboratory services provider which offers a vast array of testing capabilities across multidisciplinary areas, such as those pertaining to biomarkers, vaccines, companion diagnostics, COVID-19 focused clinical trials, bioanalysis, and clinical genomics assays.  The company claims to have supported over 150 companion diagnostics clinical trials, across the globe. The company drives these clinical development studies through its global network of central laboratories with several principal investigators and study coordinators that evaluate the developed assays for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification. 

Q2 Solutions: Company Details

Particulars	Specifications
Company Logo
Year of Establisment	2015
Headquarters	North Carolina, US
Number of Employees	1,001-5,000

The company has participated / planning to participate in various global events, including the 7th Annual Biomarker and Companion Diagnostics Conference, DIA Europe, ASCO Annual Meeting and CB & CDx Europe.

Further details on recent initiatives taken by BGI Genomics and other CDx development companies have been provided in detail in the report.

In June 2023, Quest Diagnostics Acquired Haystack Oncology to Expand the Cancer Diagnostic Portfolio and its Geographical Footprint

5. Quest Diagnostics 

Quest Diagnostics is a leading provider of diagnostic information services, including routine biological tests to specialized molecular, gene-based tests and anatomic pathology tests. The company operates through four esoteric laboratories, 40 outpatient AP laboratories, and 160 smaller, rapid-response laboratories.  In addition to providing diagnostics products and services, the company offers drug development solutions to various pharmaceutical companies and CROs, as well. The company’s portfolio comprises of precision medicine, diagnostics development, data analytics, and clinical trial services. Further, its ability to develop companion diagnostics tests for the clients, is facilitated by over 60 billion clinical data points, gathered for more than 15 years of its laboratory experience. 

Quest Diagnostics: Company Details

Particulars	Specifications
Company Logo
Year of Establisment	1967
Headquarters	New Jersey, US
Number of Employees	10,000+

In January 2024, the company acquired Steward Health Care System’s Outreach Laboratory Services business to expand the access to Quest’s Diagnostics’ services across Pennsylvania and Ohio. 

Further details on recent initiatives taken by Quest Diagnostics and other CDx development companies have been provided in detail in the report.

What About the Other Companion Diagnostics (CDx) Development Companies Around the World?

The above presentation features top 5 CDx development companies selected from a pool of over 155 players that we have compiled. If you're interested, you can download the Sample Report on this topic by Roots Analysis. For personalized assistance in identifying the most relevant solutions based on your specific criteria, please don't hesitate to reach out to us at sales@rootsanalysis.com.

Sources

1. https://gencove.com/news/bgi-and-gencove-extend-agreement-to-offer-low-pass-whole-genome-sequencing-and-analysis-services-to-advance-global-health-and-sustainability
2. https://www.eurofins.com/media-centre/press-releases-2022/2022-05-31/
3. https://www.labcorp.com/labcorp-and-legacy-health-finalize-comprehensive-laboratory-relationship
4. https://www.q2labsolutions.com/events/cb-cdx-europe
5. https://www.q2labsolutions.com/events/biomarker-companion-diagnostics 
6. https://ir.questdiagnostics.com/press-releases/press-release-details/2024/Quest-Diagnostics-Acquires-Select-Assets-of-Outreach-Lab-Services-Business-of-Steward-Health-Care-System/default.aspx