Companion Diagnostic (CDx) Services
Companion diagnostic (CDx) tests provide essential information about the optimal course for patient treatment, especially in oncology. With CDx tests, health care providers, patients and payors can be more confident that therapeutic courses are tailored to provide desired outcomes for patients.
We partner with pharmaceutical companies and clinical research organizations to develop CDx solutions for personalized therapeutic programs across a range of disease areas.
Let’s Partner to Deliver Precision Medicine
We have in-house expertise and capabilities necessary to shepherd your vision for a CDx solution, from biomarker discovery through commercialization. After establishing a shared vision and goals for our partnership, we’ll work in tandem with your drug development efforts to develop a robust assay, guide analytical and clinical validation, attain premarket approval, manufacture the assay in-house and co-commercialize the CDx test.
When you collaborate with us, you have access to our scientific expertise, regulatory capabilities and global resources crucial to navigating the development path for a regulatory-approved CDx and successfully bringing the test to market. You’ll have a dedicated project team to guide you seamlessly through all stages of the CDx development process.
Put Your CDx in Expert Hands
Assay development and optimization benefit from our deep scientific expertise with diverse technologies. Our quality control and regulatory affairs representatives are integral members of all our CDx development projects. Collaborating with our medical affairs and R&D experts, our regulatory team ensures CDx tests are validated for their intended use and that all regulatory submissions are comprehensive and accurate.
We have a network of regional resources who have experience with global regulatory submissions in the United States, Europe, United Kingdom, China, Japan and South Korea.
Meeting Your Needs
From IVD assay design to manufacturing, we can deliver a range of development options and capabilities tailored to meet the essential needs of a successful CDx program.
Tapping into our extensive expertise in core technologies provides you with more flexibility in selecting the solution that aligns best with your needs. Our capabilities span PCR, MSI, immunoassays, NGS and Sanger Sequencing. All options are agnostic to the analysis platform and testing laboratory’s location.
With over four decades of manufacturing experience and a track record of serving more than 100 global IVD companies, you can trust us to produce your CDx test. We are a primary manufacturer of molecular technologies and can adapt our products to suit your needs under quality systems that ensure consistent performance and reliable delivery. Our global supply chain, product quality, design and quality documentation are managed in-house, providing you greater peace of mind.
We maintain ISO certifications at all global manufacturing sites to demonstrate we meet industry standards. Our quality system ensures we can develop, manufacture, test and deliver high-quality products around the world.
Collaborate with Us on Your CDx Solution
We’re eager to learn more about your CDx program and to collaborate with you. Whether you have a specific project in mind or simply want to learn more about our CDx services, our Business Development team is ready to have a conversation with you.