Diagnostic Development
Your vision. Our expertise. Let’s partner to bring your vision to market—faster. Our team of experts will help you develop accurate, quality controlled and clinically validated tools for use in diagnostic laboratories. We offer capabilities in assay development, companion diagnostic services, and custom manufacturing/OEM.
Or, let’s partner to power your diagnostic assays with confidence, every time, because sample preparation is already taken care of. Our nucleic acid extraction solutions support regulatory compliance, delivering consistent performance and rapid results.
Clinical Assay Development Services (CADS)
From design and development to manufacturing of high-quality IVD assays, our Clinical Assay Development Services (CADS) provide a seamless delivery pipeline. We provide you with a superior assay development service backed by rigorous quality control, proven technical expertise and our own trusted reagents and technologies.
With CADS, you will benefit from:
- Accelerated time to market
- Deep knowledge of core technologies
- In-house control of supply chain and quality
- Scientist-to-scientist collaboration
- Range of development capabilities
- Mature design control and documentation

Extraction Solutions to Power Diagnostic Assays
Partnering with Promega means more than just sourcing a nucleic acid extraction platform—you gain an experienced team committed to supporting your assay development journey. After you’ve validated the performance of our Maxwell® CSC instruments with your IVD assay, we can provide:
- Protocol development for your sample types
- Training resources for your end users
- Global technical support and field service network
- Joint marketing assets highlighting the integrated workflow

Accelerate Assay Adoption with Built-In Automated Nucleic Acid Extraction
Benefit |
What It Means for Your Assay |
Proven Analytical Performance |
Reliable downstream results from consistent yields and quality across diverse sample types. |
Regulatory‑Ready Documentation |
Streamline your regulatory submissions with CE-marked, IVD-labeled instruments and kits (EU IVDR and US FDA IVD regulation-compliant), plus comprehensive validation data packages. |
Global Installed Base |
Reduce onboarding challenges for your customers—Maxwell® instruments are used in hundreds of labs worldwide. |
Scalable Manufacturing & Secure Supply |
Safeguard continuity as your test volumes grow, with our ISO‑certified facilities and multi‑site production. |
Custom Manufacturing and OEM
If you need a custom formulation, are looking for large-scale production capabilities or need a manufacturing partner that meets specific quality or regulatory requirements, our manufacturing services can meet your needs. Our manufacturing capabilities allow you to scale your operations efficiently, guaranteeing that the products you receive from us are high-quality, reliable, and fit your needs.
Our services include:
- cGMP manufacturing
- Custom manufacturing and OEM
- Bulk quantities and unique formulations
- Custom packaging and labeling options

Companion Diagnostic (CDx) Services
We partner with pharmaceutical companies and clinical research organizations to develop CDx solutions for personalized therapeutic programs across a range of disease areas. We have in-house expertise and capabilities necessary to shepherd your vision for a CDx solution, from biomarker discovery through commercialization.

Resources

LDT Education
Learn about laboratory-developed tests (LDTs) and in vitro diagnostics (IVD).

Custom Solutions for Clinical Diagnostics
Download this ebook to discover our custom solutions for clinical diagnostic applications.

Promega Quality Management Systems
Read about our commitment to deliver high-quality, safe and effective products worldwide.