Global Access Diagnostics

What Global Access Diagnostics does

Global Access Diagnostics (GADx), trading under Mologic Ltd, is a Bedford, UK-based contract research organisation specialising in lateral flow immunoassay (LFIA) and rapid point-of-care diagnostic technologies. Founded in 2003 by Professor Paul Davis (co-creator of the Clearblue pregnancy test) and Mark Davis, the company was acquired in 2021 by a social-impact consortium led by the Soros Economic Development Fund with Bill & Melinda Gates Foundation support for £30M+ ($41M), transitioning it into a social enterprise under Global Access Health that reinvests all surplus profits into expanding diagnostic access in low- and middle-income countries. The company operates across human, veterinary, and agricultural health verticals, offering end-to-end diagnostic development services from feasibility studies and assay design through clinical validation, regulatory affairs (CE, UKCA, FDA), and technology transfer, supported by ISO 13485-accredited quality systems and a strategic manufacturing capacity exceeding 2 million tests per day through partners.

GADx's commercial product portfolio includes COVI-Go (FDA EUA-granted COVID-19 antigen self-test), IT LEISH (visceral leishmaniasis rapid diagnostic), BotrytisAlert (vineyard Botrytis detection), Liver Fluke Test (livestock Fasciola hepatica detection), and the world-first CCHF antigen rapid diagnostic test developed with the Liverpool School of Tropical Medicine. The firm derives revenue through project-based CRO contracts with pharmaceutical companies, global health organisations (WHO, FINDdx, Gates Foundation), and research institutions, alongside direct product sales to enterprise, distributor, and global health procurement channels. Notable customers include The Pirbright Institute, Presymptom Health (NHS PRECISION trials), Bloom Diagnostics, Alamar Biosciences, and the University of Liverpool. The business is supported by a 51–100 person team with deep specialisation in antibody engineering and bioconjugation chemistry, and operates from UK headquarters, a US subsidiary in Maine, and a Bedfordshire manufacturing facility, with distribution reach into 12+ countries across Europe, North America, East/West Africa, and the Middle East.

Name

Global Access Diagnostics

Legal name

Mologic Ltd

Website

https://globalaccessdx.com

Company type

Private

Founded year

2003

Operating status

Operating

Headcount range

51–100 employees

Short description

UK-based contract research organisation developing lateral flow and rapid point-of-care diagnostic tests for human, veterinary, and agricultural health; serves pharmaceutical companies, global health organisations, and research institutions with end-to-end services from feasibility through regulatory approval and technology transfer.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics Contract Research and Manufacturing

NAICS

Scientific Research and Development Services (5417), Medical Laboratories (621511)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Medical Laboratories (8071)

akta.pro primary industry

Companion Diagnostics (CDx) Development & Trial Testing Support (HLAGAEAJ)

akta.pro secondary industries

Companion Diagnostic (CDx) Co-Development Services (biopharma partnerships, clinical strategy) (HLAAAMAB), GxP Audits & Supplier Qualification (GMP/GCP/GLP/GDP) (HLAGAKAE)

Keywords

• Rapid diagnostic tests
• Lateral flow assays
• Contract research services
• Point-of-care diagnostics
• Diagnostic test development

Headquarters

HQ city

Bedford

HQ country

United Kingdom

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Supply Chain, Marketing or Sales, Infrastructure

Revenue model

1. Contract Research & Development Services: GADx provides end-to-end diagnostic commercialisation and development services for clients from early-stage startups to global pharmaceutical companies. Services include feasibility studies, assay development, reagent analysis, device prototyping, clinical validation, technology transfer, and regulatory affairs. Revenue is earned through project-based professional service contracts.
2. Diagnostic Product Sales: Sale of manufactured diagnostic test kits including IT LEISH (visceral leishmaniasis), COVI-Go (COVID-19), BotrytisAlert (agricultural), and liver fluke tests. Revenue generated from product sales to global health organisations, healthcare providers, and agricultural sector customers.
3. Technology Transfer & Scale-Up Services: Technical transfer of products from R&D bench to scaled manufacture with strategic manufacturing partners, including process validation, QC documentation, and regulatory submission support.
4. Social Enterprise Reinvestment Model: As a social enterprise owned by Global Access Health, GADx reinvests all surplus profits into impact-led development programs that deliver rapid diagnostic tests prioritising pressing unmet health needs in low- and middle-income countries.

Pricing tiers

Go-to-market motion1 record

Distribution channels5 records

Marketing channels6 records

Core offering

Global Access Diagnostics (GADx) is a contract research organisation that designs, develops, validates, and manufactures lateral flow and rapid diagnostic tests for human, veterinary, and plant health applications. It sells an end-to-end diagnostic development service from feasibility studies through clinical validation, regulatory affairs, and technology transfer, alongside a portfolio of in-house diagnostic products such as COVI-Go, IT LEISH, BotrytisAlert, a liver fluke test, and the CCHF antigen RDT.

Product overview

Global Access Diagnostics (GADx) operates as a contract research organisation offering end-to-end diagnostic commercialisation services, combining scientific excellence with proven commercialization expertise. The company's product portfolio centers on lateral flow immunoassay (LFA) technology for rapid point-of-care diagnostics across human, veterinary, and agricultural applications. Key products include COVI-Go (FDA-authorized COVID-19 self-test), IT LEISH (rapid test for visceral leishmaniasis), BotrytisAlert (agricultural pathogen detection), Liver Fluke Test, and Cystatin C Kidney Test. GADx provides comprehensive contract research services including assay design, product development, clinical validation, technology transfer, and regulatory affairs. The company also develops companion diagnostics and therapeutic support tests, and manufactures over 2 million tests per day capacity through strategic partnerships.

Differentiator

Problem solved

Functional benefit

Brands

• COVI-Go: COVID-19 rapid antigen self-test that received FDA Emergency Use Authorization for home use
• IT LEISH
• BotrytisAlert
• Liver Fluke Test
• AgriAlert

Products and services

• COVI-Go COVID-19 Self-Test FDA EUA-authorised rapid antigen COVID-19 self-test with a novel two-component all-in-one design featuring an integrated buffer, delivering results in 20 minutes for individuals aged 2 and above with or without symptoms. Commercialised via partner organisations to serve US OTC and LMIC distribution.
• IT LEISH Rapid Diagnostic Test High-performance immunochromatographic rapid diagnostic test for visceral leishmaniasis (VL), a life-threatening neglected tropical disease. UKCA-marked, generates results in 20 minutes, can be performed in field settings with minimal training, and is independently verified as the most sensitive VL test available in East African and South American settings. Manufacturing rights acquired from Bio-Rad in September 2022.
• BotrytisAlert Lateral Flow Test Rapid lateral flow diagnostic test for detecting Botrytis bunch rot (Botrytis cinerea) in wine grapes and horticulture. Enables farmers to objectively assess Botrytis concentration at the vineyard without laboratory equipment, supporting targeted crop protection decisions and reducing prophylactic pesticide use.
• Liver Fluke Rapid Diagnostic Test Rapid antibody detection test for Fasciola hepatica (liver fluke) infection in sheep and cattle. Uses a blood droplet from the ear and delivers results in 10 minutes on-site without laboratory equipment, enabling farmers to implement targeted treatment programmes and combat anthelmintic resistance. Developed with the University of Liverpool with support from AHDB and BBSRC.
• CCHF Rapid Diagnostic Test World's first rapid diagnostic test capable of detecting Crimean-Congo Haemorrhagic Fever (CCHF) viral antigens. Developed in partnership with the Liverpool School of Tropical Medicine with funding from the Medical Research Council, demonstrating clinical sensitivity and specificity exceeding WHO Target Product Profile minimum thresholds. Deployed in multi-site prospective studies across Turkey and Iraq (~500 patients).
• Cystatin C Kidney Test (for Bloom Lab Platform) Custom-developed rapid kidney function test measuring cystatin C levels for incorporation into Bloom Diagnostics' Bloom Lab platform. Delivered with analytical verification testing, design history file documentation, and device card manufacturing/QC support to enable Bloom's market launch.
• Lateral Flow Diagnostic Development Services (CRO) End-to-end contract research services covering feasibility studies, assay development, reagent analysis, device prototyping, clinical validation, technology transfer, and regulatory affairs for human, veterinary, and plant health lateral flow diagnostics. Engagements use a phased methodology with bite-sized work packages and explicit Go/No-Go decision points to manage sponsor risk, delivered by an ISO 13485-accredited team.
• Technology Transfer and Scale-Up Services Technical transfer of diagnostic products from the R&D bench to scaled manufacture with strategic partners. Includes process validation, QC testing procedures, analytical and clinical validation, and preparation of manufacturing, regulatory, and quality documentation, with manufacturing capacity exceeding 2 million tests per day through partners.
• Regulatory and Clinical Affairs Services Clinical trial management and regulatory submission support covering trial design, trial centre management, patient recruitment, data evaluation, study reporting, and preparation of regulatory dossiers for CE, UKCA, and FDA pathways across global trial networks.

Quantifiable outcome

• CCHF rapid diagnostic test achieved 90.4% sensitivity and 96.2% specificity in Türkiye clinical samples, exceeding WHO Target Product Profile minimum thresholds
• +4 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature9 records

Partnerships

14 partnerships are on record, tiered core and minor.

• BBI SolutionscoreStrategic or Co-development Partner · 10 October 2025Strategic collaboration announced October 2025 to accelerate rapid lateral flow product development and manufacturing for commercial customers. Combines GADx's assay design, product development, and clinical validation expertise with BBI Solutions' world-class manufacturing infrastructure. Aims to deliver seamless technology transfer, reduced time-to-market, enhanced manufacturing capacity, de-risked supply chain, and regulatory excellence (CE, UKCA, FDA).
• HOLICARE ConsortiumcoreStrategic or Co-development Partner · 11 September 2024GADx partnered with an international consortium to improve diagnosis in low- and middle-income countries through the HOLICARE project — a groundbreaking initiative for epidemic surveillance.
• ARPA-H Investor Catalyst Hub (managed by VentureWell)minorStrategic or Co-development Partner · 18 June 2024GADx selected as a spoke for ARPA-H Investor Catalyst Hub, a regional hub of ARPANET-H, the US nationwide health innovation network. Spoke membership provides access to potential funding, flexible contracting for faster award execution, networking, and input on challenge priorities.
• DIDIDA Consortium (14 partners across 8 countries)coreStrategic or Co-development Partner · 10 October 2022GADx participates in the EU-funded DIDIDA project (Digital Innovations and Diagnostics for Infectious Diseases in Africa). Consortium of 14 partners from Kenya, Senegal, Tanzania, Uganda, UK, France, Netherlands, and Italy developing mobile phone-connected multiplex diagnostics for infectious diseases and NCDs in sub-Saharan Africa. Funding: ~€6M from EU Horizon Europe and £2M from UKRI. GADx contributes lateral flow and diagnostic development expertise.
• FINDdxcoreStrategic or Co-development Partner · 13 May 2022Partnership for schistosomiasis rapid test development. Neglected Tropical Diseases affect more than one billion people worldwide, and schistosomiasis is a disease of poverty targeted by WHO for elimination.
• Alamar BiosciencesminorStrategic or Co-development Partner · 4 May 2022Collaboration to develop a next-generation COVID-19 antigen test combining Alamar Biosciences' proteomics platform with GADx's lateral flow expertise.
• Liverpool School of Tropical Medicine (LSTM)coreStrategic or Co-development Partner · 1 January 2022Over two years, GADx partnered with LSTM to translate a CCHF rapid diagnostic concept into a scalable and deployable product. LSTM developed the initial proof-of-concept RDT. GADx contributed monoclonal antibody development, lateral flow test design, optimisation, and training. Funded by Medical Research Council. Resulted in world-first CCHF antigen RDT with clinical sensitivity/specificity exceeding WHO TPP thresholds.
• Iraq Centres for Disease ControlcoreStrategic or Co-development Partner · 1 January 2022Partner in the CCHF rapid diagnostic test development program alongside LSTM and Turkey Ministry of Health. Iraq contributed to multi-site clinical validation and epidemiological expertise.
• Ministry of Health TurkeycoreStrategic or Co-development Partner · 1 January 2022Partner in CCHF RDT development, conducting prospective multi-site pre-clinical and usability studies across secondary health clinics in hyperendemic regions of Turkey with approximately 500 patients enrolled during the 2026 outbreak season.
• Bloom DiagnosticsminorStrategic or Co-development Partner · 1 August 2021Working with Bloom Diagnostics, GADx developed a Cystatin C Kidney Test for incorporation into Bloom's existing Bloom Lab platform. GADx provided assay development, analytical verification testing, preparation of documentation for design history file, and device card manufacturing/QC support.
• University of LiverpoolcoreStrategic or Co-development Partner · 1 January 2021University of Liverpool sought GADx expertise to develop a liver fluke rapid diagnostic test. GADx carried out market review, developed industry questionnaire, merged industry data with production needs, and developed the test detecting antibodies in blood droplet from the ear, delivering results in 10 minutes on-site. Project supported by AHDB and BBSRC.
• The Pirbright InstitutecoreStrategic or Co-development Partner · 1 January 2021Long-term collaboration for developing lateral flow assays for rapid avian influenza detection and Nipah virus detection in pigs. GADx team applied expertise to troubleshoot and design assays overcoming challenges encountered. Demonstrates exceptional technical excellence and responsiveness advancing translational research from lab to field.
• Presymptom HealthcoreStrategic or Co-development Partner · 1 January 2021GADx supported Presymptom Health since 2021 delivering the multi-site PRECISION clinical trial across the NHS despite challenging COVID conditions. Professional, responsive, and efficient approach led to continued partnership for PRECISION 2.0 trial advancing toward mainstream clinical use.
• Manufacturing Partners in Africa and South AsiacoreStrategic or Co-development Partner · 1 January 2021Local manufacturing partnerships enabling delivery of high-quality affordable diagnostics to underserved populations in Africa and South Asia. GADx transfers technology to low-middle income countries, supporting decentralised manufacturing as part of its social enterprise mission.

Scale indicators13 records

Recent moves9 records

Expansion highlights7 records

Broad incumbents

• Eurofins Scientific: Global bioanalytical testing and contract research services group serving pharma, food, and clinical diagnostics. Comparable to GADx in providing outsourced diagnostic development and testing services, but at vastly larger scale.
• QuidelOrtho: Major global IVD and lateral flow test developer (e.g., QuickVue, Sofia). Overlaps with GADx in rapid lateral flow diagnostics but operates at much broader scale and across many more disease areas.
• Bio-Rad Laboratories: Global IVD and life science research company; former manufacturer of IT LEISH before transferring rights to GADx. Overlaps with GADx in lateral flow IVDs and clinical diagnostics reagents.
• Abbott Diagnostics (now including Alere): Global diagnostics leader with extensive lateral flow / rapid test portfolio (Binax, Panbio, etc.). Competes broadly in the same rapid POCT categories as GADx but at significantly greater scale and commercial reach.

Direct peers

• EKF Diagnostics: UK-based point-of-care diagnostics developer and manufacturer with both proprietary products (e.g., hemoglobin, HbA1c, COVID tests) and contract manufacturing services. Comparable mid-sized diagnostics business with overlapping POC lateral flow capabilities.
• Abingdon Health: UK-based lateral flow contract development and manufacturing organization offering end-to-end assay development, scale-up, and regulatory support. Direct comparable to GADx as a lateral flow CRO serving diagnostics and veterinary markets.
• Sona Nanotech: Developer of lateral flow rapid diagnostic tests for human and animal health applications. Competes in the same lateral flow point-of-care development space, particularly for NTD and infectious disease targets.
• DCN Diagnostics (parent of BBI Solutions / Novarum DX): Provides lateral flow contract development, reagents, and manufacturing services including via BBI Solutions, GADx's strategic manufacturing partner. Highly comparable business model combining CDx/IVD development with scale-up manufacturing.

Others

• FIND (Foundation for Innovative New Diagnostics): Global non-profit that drives development and delivery of affordable diagnostics for poverty-related diseases. Direct NTD/global health diagnostics partner to GADx, shaping the same target market rather than competing commercially.

Regional players

• Mestrelab Research / Mast Group: UK/Europe-based IVD and microbiology diagnostic developer with point-of-care lateral flow tests for human and veterinary use. Comparable regional diagnostics player overlapping with GADx's lateral flow focus across European markets.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/GlobalAccessDx
• LinkedInlinkedin.com/company/globalaccessdx

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Global Access Diagnostics