Clinical Assay Development Services

Bring your assays to market faster. 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

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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.

Learn More about our Lumit® Technology >

How Lumit® Flex Works

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.

Add-Mix-Read Workflow

Lumit® Flex is an easy, no-wash workflow for automation-friendly analyte detection.

Flexible Formats

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

Single Samples

Low-to-Mid Throughputs

High-Throughput

Key Benefits

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.