Contract Research
Global Access Diagnostics (GADx) offers a comprehensive range of lateral flow immunoassay development services to researchers, developers and manufacturers of rapid point-of-care assays. We are ISO13485 certified and experienced in developing rapid tests for human, animal and agricultural applications.
Assay Development
Our team of scientists has extensive experience in dealing with simplex or multiplex lateral flow tests using visible or fluorescent labels for qualitative or quantitative tests. Whether single strips, or strips in housings, we can cover your needs. Housing design, prototyping and testing is all part of the service we offer to make your product distinct and suited for your target market.
Over many years developing lateral flow assays for inflammatory biomarkers where up to five test lines are required, we have built an enviable competency in algorithm creation and incorporation into reader systems. These tools make a powerful addition to result interpretation in multiplex assay systems and are all part of our service.
GADx can help with everything from identifying the right proteins and antibodies, to designing the most effective device and scaling up low- to mid-volume manufacture.
All of our work is carefully stage-gated, from proof of concept to launch. We review progress together and ensure we’re making the right decisions to develop your assay or product.
Reagent Development
GADx has produced hundreds of rare biomolecules for clients and for our own in-house development. Our expertise is in the production of highly specific and well characterised reagents including those used in immunoassays where performance is directly related to reagent sensitivity, specificity and purity. We have deep experience in developing or sourcing high affinity antibodies and controlling methods for production of recombinant binding molecules that are directed toward your analyte of interest. In addition, we’ve developed methods for increasing the immunogenicity of your antigen with the inclusion of virus like particles (VLP) in the immunisation strategy.
We can also provide epitope mapping of the antigen to confirm the specificity of the response through peptide libraries. GADx offers peptide and antigen synthesis, nanoparticle / enzyme conjugation and additional reagent development services related to:
- Epitope design
- Antibody and Nanobody production
- Antibody screening and binding characterisation
- Exploratory recombinant protein production (E. coli and yeast)
Reagent Enrichment / Process Development
Affinity purification is an ideal way to increase reagent specificity. GADx can provide detailed purification strategies or deliver highly purified material based on your target antigen. We offer additional process development services relating to enrichment of recombinant proteins and monoclonal antibodies. Our experience in immunoassay design has allowed us to optimise and develop procedures for biomolecule conjugation, including scale-up for manufacture.
Reagent Analysis
Impure reagents can lead to downstream design flaws and finished product instability, so it is crucial we ensure reagents are free of contaminants. GADx has invested heavily in both staff and equipment capability to fully assess reagent purity. To do this, we utilize chromatography tools (for example FPLC, HPLC), electrophoresis tools (for example SDS-PAGE/ Western blot) and spectrometry tools (for example UV/VIS, fluorimetry, dynamic light scattering, and mass spectrometry).
The characterisation of biomolecule activity is paramount to its utility and allows for appropriate downstream inclusion. Our capability uses information gathered from peptide epitope mapping, bioactivity testing, flow cytometry / imaging microscopy and label free kinetic analysis (which is superior to SPR results) to optimize the reagent’s ability to function exceptionally well in the finished product.
Our development packages (immunoassay, antibody, recombinant protein) include a range of analytical testing methods to ensure quality and activity of critical reagents specifically relating to identity, purity, and stability. We are also able to offer reagent analysis as a standalone service to provide characterization for already-developed materials.
Device Format Development
Immunoassays come in many shapes, sizes, and forms. GADx has been involved in them all, from microwell EIA testing, to dipstick lateral flow tests, to fully integrated over the counter disposable systems. Our experience can help ensure the housing design and assay choreography is supportive of assay performance and usability, whatever the application. Working with a carefully selected group of creative industrial designers we can help you ensure products have the desired ‘market presence’ and the required functionality. During early stages of the project we rapidly prototype (3D printing) custom housings for exploring usability and function.
Evaluation & Validation Services
GADx’s core competency is in delivering immunoassays that meet a market need. This involves verifying clinical utility with confirmed samples, characterization and elimination of sample matrix effects, and product shelf-life stability. These important activities are included with any of our contract development offerings and can be utilised separately, for your specific needs. We are ISO 13485:2016 certified and can provide design history files, batch records and other required regulatory documentation. We have strong links to the clinical community and have undertaken numerous trials, so we can facilitate small scale clinical trials as well as training sets and user simulation sessions.
Connected Diagnostics
GADx is committed to enabling tests to be digitally connected to support more accurate diagnoses and better use of data to support surveillance and other public health needs. We can work with you ensure the tests we develop together are readable by a variety of readers, and can help you select the right partners to develop companion apps, middleware and other data management services.
Who Benefits from GADx Contract Research Services?
Diagnostic companies and Academic partners
You are looking for innovation and scientific excellence to help advance your R&D agenda and ensure your devices are the best on the market.
Pharma and Life Sciences Companies
You are looking for a rapid pre-clinical diagnostic to stratify patients or to monitor biomarker trends.
Global Health R&D Funders
You are looking for a company that prioritizes impact to address a pressing global health need, safe in the knowledge that our incentives are aligned to continue to provide products with access and impact prioritized above profit.
Concept to Customer Made Easy
Exploration
Let’s find out if we are the best fit. We discuss your needs and explore the best possibilities to meet them. This no-obligation consulting phase will lead to a Scope of Work defining technical, regulatory and market requirements, resulting in a quote.
Prototyping and validation
Upon your approval we continue to the initial production and verification phase with carefully structured stage gating, excellent project management and ongoing quality assurance.
Production
When all requirements are met we transfer to manufacturing and will meet your objectives in flexible volume, time, quality and cost.
Distribution
We ship to you directly or can help you distribute your product through our established international distribution network.
CASE STUDIES & NEWS ARTICLES
By Dr Alison Wakeham
How in-field diagnostics can reduce waste on farms and promote sustainable agriculture
Did you know that on a global scale up to 40% of crops are lost to pests and diseases? This article provides an overview on the waste associated with…
By Dr Julia Rogers
Cystatin C test: Developing a rapid test to allow users to track kidney function
Working with Bloom Diagnostics, Global Access Diagnostics (GADx) developed a Kidney Test to measure cystatin C level, a well-established indicator of kidney function. What is CKD? Kidneys play a…
Get In Touch
How can GADx help you get tests to people to take charge of their health?
For sales inquiries please contact sales@globalaccessdx.com
For technical support please contact technicalsupport@globalaccessdx.com
UK: +44 (0) 1234 780020
USA: +1 (888) 381-6870
Frequent testing is invaluable and so it is vital to find ways to drive down the cost of kits and increase production levels. As a social enterprise, GADx can transform this process because it ‘breaks the link’ of ‘having to make profit for shareholders’.
Paul Davis
Co-founder of Mologic and pioneer of lateral flow diagnostics.