Clinical Assay Development Services
Bring your assays to market faster. From design and development to manufacturing of high-quality molecular 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
Simplify with a Single Partner from Beginning to End
Other assay development providers rely on outside resources to deliver on your ideas, slowing your progress and obscuring critical workflows.
We offer a uniquely comprehensive portfolio of technology development, manufacturing and logistics that enable us to support every step of your clinical assay development, from conception to delivery. Our streamlined, transparent workflows mean you can bring your ideas to market sooner.
Available Technologies
Lumit® Flex Technology
Lumit® Flex technology enables bioluminescence-based detection of specific antigens or antibodies, simplifying immunoassay protocols and accelerating time to results. Based on our award-winning NanoLuc® luciferase and NanoBiT® complementation system, the Lumit® Flex System enables sensitive, fast, and accurate immunoassays for clinical applications.
This patented "Add-Mix-Read" technology offers flexibility in sample type, analyte choice, assay format and workflow. It can be adapted to formats including point-of-care (POC) to high-throughput testing.
Lumit® Flex System simplifies immunoassays. Based on a luminescent structural complementation system consisting of two small peptide tags (Peptide α and Peptide β) and a reagent-based polypeptide (Detection Subunit), Lumit® Flex System is an add-mix-read alternative to more time-consuming and complex immunoassays.
Example 1: Protein Detection
Antibodies are chemically labeled with peptide tags or produced as recombinant genetic fusion, shown below as Peptide α and Peptide β. In the presence of the target analyte, the labeled antibodies bind the protein, bringing the peptide subunits into close proximity allowing the binding of Detection Subunit present in the solution to reassemble into a functional luminescent enzyme that generates a luminescent signal in the presence of substrate.
Example 2: Antibody Detection (anti-COVID19 Spike Protein Antibody)
Proteins produced as genetic fusions with the small tags, shown below as Peptide α and Peptide β. In the presence of the target antibody, the labeled proteins bind their antibody epitope, bringing the peptide subunits into close proximity allowing the binding of Detection Subunit present in the solution to reassemble into a functional luminescent enzyme that generates a luminescent signal in the presence of substrate.
Lumit® Flex is an easy, no-wash workflow for automation-friendly analyte detection.
Lumit® Flex technology offers flexibility in sample type, analyte choice, assay format and workflow. It can be adapted to formats including point-of-care (POC) to high-throughput testing
Simple Samples
Low-to-Mid Throughputs
High-Throughput
| Lumit® Flex Key Features | Your Advantage |
|---|---|
| Fast: total assay time is ~5–90 minutes | Save time |
| Flexible Format | Flexibility in the sample type, analyte choice, assay format and workflow |
| Homogeneous, add-mix-read format | Reduce resource needs, manual error and re-test rate |
| Superior sensitivity with large dynamic range and low background | Improved detection of your desired target |
| Only requires a standard luminescent-capable microplate reader | Save on large capital equipment investment and overnight cleaning steps (cross-contamination) |
| No washes or multiple incubation steps | Improve consistency in your data |
| Directly measures antibody binding to antigen | Provides superior sensitivity and specificity |
| Scalable | Amenable for point-of-care and high-throughput applications |
| Robust stability and lyophilization compatibility | Room temperature stable, all-in-one assays |
| Suitable for difficult targets and sample types | Easier detection and superior sensitivity compared to other technologies |
Manufacturing and OEM Services
With 40+ years of manufacturing experience and a track record of serving more than 100 global IVD companies, you can trust us to produce your assay. We offer manufacturing expertise in a variety of areas including:
- Fermentation
- Custom Manufacturing
- Amplification and Human Identify
- cGMP Contract Manufacturing
- Nucleic Acid Chemistry
- Bioluminescence
- Cell Manufacturing
- Protein Purification
As a primary manufacturer of molecular technologies, we can adapt our products and technologies to suit your unique needs. We’ll modify product formulations and packaging to your specifications, all under quality systems that ensure consistent performance and on-time delivery.
Our manufacturing infrastructure features:
- Room to grow for future needs: over 450,000 square feet (41,000m2) of manufacturing space.
- Strong relationships: Over half of our suppliers are located within 50 miles of our Madison, Wisconsin manufacturing facilities.
- Deep knowledge: The average tenure of our manufacturing leaders is 15+ years.
- Exemplary customer experience: surveyed customers have >99% satisfaction rate.
Committed to Quality and Support
Our rigorous quality system ensures we can develop, manufacture, test and deliver high-quality products around the world. Our global supply chain, product quality, design and quality documentation are managed in-house, providing you greater peace of mind.
To demonstrate our commitment to meeting industry standards, we maintain ISO certifications at all global manufacturing sites.
- ISO 9001:2015 Provides general quality management system requirements
- ISO13485:2016 Provides quality management system requirements for medical devices
- ISO18385:2016 Minimizes the risk of human DNA contamination in products
- MDSAP (Medical Device Single Audit Program)
- ISO 13485:2016
- Canada – Medical Device Regulations – Part 1 – SOR 98/282
- USA – 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 – Subparts A to D
Let's Partner to Develop Your Next Assay
We welcome the opportunity to develop your next assay. Whether you have a project in mind or simply want to get more details about how our capabilities can meet your needs, please request a conversation with our CADS Team by filling out the form linked below.
References and Intended Use Statement
- Torio, E.A. et al. (2022) Development of a rapid, simple, and sensitive point-of-care technology platform utilizing ternary NanoLuc. Front. Microbiol. 13. This article is distributed under the Creative Commons Attribution 4.0 International License.
GloMax® Microplate Readers are for research use only. Not for use in diagnostic procedures.