Highfield Diagnostics

What Highfield Diagnostics does

Highfield Diagnostics is a UK-based point-of-care diagnostics company that has developed and commercializes flowDx, a proprietary laser-based platform technology for manufacturing advanced lateral flow tests. Founded in 2017 and formally spun out from the University of Southampton's Optoelectronics Research Centre in April 2021 with pre-seed investment from Verge HealthTech Fund, the company uses laser patterning to engineer fluid-flow paths within the cellulose pads, glass-fibre pads, and nitrocellulose membranes that make up lateral flow test strips. This patterning enables capabilities not available in conventional lateral flow devices: multiplexed detection of multiple biomarkers in a single test, enhanced sensitivity with up to 240% signal improvement and 800% improvement in lower limit-of-detection, and semi-quantitative measurement through pre-loaded test-line architectures. The company is targeting a sub-penny per-test manufacturing cost at scale via its SCIENION GmbH partnership, with patterning speeds of approximately one device per second at 250 micrometer resolution.

The company's first commercial product, the Hi-Sens CRP/SAA Rapid Test, received CE Mark approval in September 2024 for simultaneous qualitative detection of C-Reactive Protein and Serum Amyloid A biomarkers in whole blood, serum, or plasma, marking its entry into European markets. Its primary end-users are healthcare providers managing chronic inflammatory conditions, point-of-care testing facilities, and public health programs in epidemic-prone regions, with stated adaptability into adjacent verticals including veterinary medicine, water quality testing, and food and beverage safety. Active pipeline programs include a six-channel lung cancer lateral flow test developed under a £1 million Innovate UK consortium grant announced in December 2023 and a tuberculosis triage test under development in partnership with Sri Devrajurs Academy in India.

Highfield's business model combines three revenue streams: direct sales of proprietary diagnostic products, licensing of flowDx technology to global diagnostics manufacturers (with active Chinese manufacturer collaborations to enhance existing colloid gold and fluorescent LFT products), and contract manufacturing through SCIENION. Distribution combines direct enterprise sales to healthcare providers with OEM and consortium partnerships for global reach. The team of approximately 1-10 employees is anchored by four scientific founders from Southampton's Optoelectronics Research Centre with more than 50 years of combined experience, alongside CEO Rene Schuster, who brings prior executive experience at KPMG, Vodafone, and Telefonica, and commercialization support from US-based venture development firm Ambershore Group.

Name

Highfield Diagnostics

Legal name

Highfield Diagnostics Ltd

Website

https://highfielddiagnostics.co.uk

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

1–10 employees

Short description

Highfield Diagnostics is a UK-based point-of-care diagnostics company that has developed flowDx, a proprietary laser-based platform for manufacturing advanced lateral flow tests with multiplexing, enhanced sensitivity, and semi-quantitative capabilities, serving healthcare providers, epidemic-response programs, and adjacent verticals.

Ownership category

akta.pro rank

Product category

Point-of-Care Diagnostics (Lateral Flow Devices)

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Rapid Antigen/Antibody Lateral Flow Tests (General Platform Category) (HLAHAOAH)

Keywords

• Lateral flow diagnostics
• Point-of-care testing
• Multiplexed diagnostics
• Laser-patterned microfluidics
• Paper-based diagnostic devices

Headquarters

HQ city

Southampton

HQ country

United Kingdom

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic Device Sales: Sale of proprietary diagnostic products including the CE Mark-approved Hi-Sens CRP/SAA Rapid Test. Products are sold to healthcare providers, clinics, and point-of-care testing facilities.
2. Technology Licensing: Licensing of flowDx technology to global diagnostics companies and manufacturers for enhancing their existing lateral flow devices. Collaboration with Chinese manufacturers to demonstrate and validate hi-sens technology applications on colloid gold-based and fluorescent lateral flow products.
3. Contract Manufacturing Services: Partnership manufacturing through Scienion for mass production of flowDx-enabled lateral flow tests at scale.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

Highfield Diagnostics manufactures and licenses proprietary laser-patterned lateral flow diagnostic devices through its flowDx® platform technology, which engineers fluid-flow paths within paper-based test components to enable multiplexed, high-sensitivity, and semi-quantitative point-of-care testing. Its first CE Mark-approved commercial product is the Hi-Sens CRP/SAA Rapid Test for simultaneous detection of inflammatory biomarkers, with the platform additionally licensed to global diagnostics manufacturers for integration into their existing LFT products.

Product overview

Highfield Diagnostics is a point-of-care diagnostics company that offers a platform-plus-products architecture. The core offering is the proprietary flowDx® laser-based platform technology, which patterns and engineers fluid-flow paths within lateral flow test components to enable multiplexed, high-sensitivity, and quantitative diagnostic testing. The company commercializes this platform through its first CE-marked product, the Hi-Sens CRP/SAA Rapid Test for inflammatory biomarker detection. Additional pipeline products include TB triage tests and lung cancer diagnostic tests (developed in partnership with UK and international collaborators). The flowDx platform is also being licensed to global diagnostics manufacturers to enhance their existing lateral flow products.

Differentiator

Problem solved

Functional benefit

Brands

• flowDx: Laser-based platform technology for manufacturing lateral flow tests that enables flow control, multiplexing, enhanced sensitivity, and semi-quantitative results. Used for patterning fluid-flow paths in lateral flow test components.
• Hi-Sens
• Hi-Sens CRP/SAA Rapid Test

Products and services

• flowDx® Platform Technology A proprietary laser-based platform technology for patterning the building blocks of lateral flow tests (cellulose pad, glass-fibre pad, nitrocellulose membrane). It creates uniquely shaped fluid-flow paths at specific locations within these materials to enable multiplexed, high-sensitivity, and semi-quantitative lateral flow devices. The platform is licensed to global diagnostics manufacturers and integrated into CE Mark-approved products, with non-contact patterning at 1 device per second and ~250 µm resolution.
• Hi-Sens CRP/SAA Rapid Test An advanced high-sensitivity Lateral Flow Assay (LFA) for simultaneous qualitative detection of C-Reactive Protein (CRP) and Serum Amyloid A (SAA) biomarkers in whole blood, serum, or plasma. Built on proprietary flowDx® Hi-Sens technology, it enhances colour intensity at test lines and improves sensitivity and limit-of-detection compared to traditional LFTs, aiding early detection and management of inflammatory conditions and differentiation between viral and bacterial infections. Intended for healthcare providers, hospitals, clinics, and point-of-care testing facilities.

Quantifiable outcome

• Signal enhancement of up to 240% compared to conventional lateral flow tests
• +4 more outcomes

Named customers3 records

Segments6 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Ten partnerships are on record, tiered major, minor and core.

• Life Science GroupmajorStrategic or Co-development Partner · 1 December 2023Lead partner in £1 million Innovate UK consortium for early lung cancer diagnostic test development. Managing director Jenny Murray serves as Project Lead for the consortium.
• Aberystwyth UniversitymajorStrategic or Co-development Partner · 1 December 2023Research partner providing lung cancer biomarker research. Professor Luis Mur leads biomarker identification work with six biomarkers achieving 90% accuracy for early-stage lung cancer diagnosis.
• ProTEM ServicesminorStrategic or Co-development Partner · 1 December 2023UK company partner in Innovate UK consortium for lung cancer diagnostic test development.
• Valley DiagnosticsminorStrategic or Co-development Partner · 1 December 2023UK company partner in Innovate UK consortium for lung cancer diagnostic test development.
• Sri Devraj Urs Academy of Higher Education and ResearchcoreStrategic or Co-development Partner · 1 October 2023Collaboration with Prof Prabhakar and Dr Anitha's team for TB triage test development. MoU signed for long-term partnership with access to extensive clinical samples from semi-urban India. Collaboration resulted in promising findings to refine prototype TB lateral flow test.
• Chinese Lateral Flow Test ManufacturersmajorChannel Partner/ Reseller/ Distributor · 1 October 2023Multiple Chinese test developers and manufacturers collaborating to demonstrate and validate hi-sens technology application for enhancing performance of their existing colloid gold-based and fluorescent lateral flow products.
• Scienion GmbHcoreStrategic or Co-development Partner · 5 July 2022MoU signed for cooperation in development and implementation of mass manufacturing processes for Highfield's flowDx platform. Scienion provides world-class design and manufacturing capabilities including precision dispensing equipment and high-volume LFT production capacity. Partnership aims to achieve cost impact of less than one penny per test while maintaining existing manufacturing speeds.
• Ambershore GroupcoreImplementation/ SI/ Consulting PartnerUS-based venture development firm that accelerates growth and improves readiness for investment. Manages commercialization of core technology and development of early applications. Provides governance, operational and commercial support.
• University of Southampton Optoelectronics Research CentrecoreStrategic or Co-development PartnerSource of spin-out technology. More than seven years of academic research conducted through EPSRC funding. Continued partnership with Faculty of Medicine for developing proprietary point-of-care diagnostic solutions.
• Hywel Dda University Health BoardminorStrategic or Co-development PartnerWelsh health board partner in consortium for lung cancer diagnostic test development including involvement in clinical validation.

Scale indicators10 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Mologic: UK-based developer of lateral flow and rapid diagnostic tests with academic spin-out origins, focused on point-of-care and global health applications. Highly comparable in size, focus, and platform-based approach to Highfield Diagnostics.
• Abingdon Health: UK-based lateral flow contract development and manufacturing organization serving diagnostics companies globally. Comparable as a UK-headquartered LFT specialist offering both proprietary products and contract services.
• DCN Diagnostics: Custom lateral flow assay developer and contract manufacturer serving diagnostic test developers. Highly comparable as a developer of novel LFT technologies and contract manufacturing services similar to Highfield's Scienion partnership model.
• Senova: German developer and manufacturer of lateral flow tests including novel immunoassays for point-of-care applications. Comparable as a European LFT innovator of similar scale focused on novel assay formats.

Broad incumbents

• Abbott Rapid Diagnostics: Global leader in rapid diagnostics including the BinaxNOW and Panbio lateral flow product lines. Represents the dominant incumbent competing across all major LFT segments Highfield targets.
• Becton Dickinson (BD): Global medical technology company with the BD Veritor lateral flow platform serving point-of-care testing markets. Competes broadly across LFT segments targeted by Highfield.
• Sekisui Diagnostics: Global diagnostics company offering lateral flow and rapid test products across clinical and non-clinical segments. Comparable as a broad incumbent with overlapping LFT capabilities.
• QuidelOrtho: Major diagnostics company with extensive lateral flow product portfolio including Sofia and QuickVue brands. Directly competes in rapid diagnostics and POCT markets that Highfield serves.

Regional players

• Zhejiang Orient Gene Biotech: Major Chinese lateral flow test manufacturer with global distribution; comparable to the type of manufacturer Highfield is partnering with to license flowDx technology into Chinese LFT products.

Emerging players

• Fujirebio: Japanese diagnostics company developing immunoassays including lateral flow-based tests for infectious disease and other biomarkers. Comparable as an emerging diagnostics specialist expanding lateral flow capabilities.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/highfielddiagnostics
• LinkedInlinkedin.com/company/highfield-diagnostics

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds1 record

Investors1 record

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 Highfield Diagnostics