Cambridge Life Sciences

What Cambridge Life Sciences does

Cambridge Life Sciences Ltd is a UK-based in vitro diagnostic (IVD) manufacturer and contract development partner founded in 1985 and headquartered in Ely, Cambridgeshire. The company develops, manufactures, and distributes enzymatic and colorimetric assay kits for therapeutic drug monitoring (paracetamol K8003/K8004 and salicylate K9001), the Endosc-HP® rapid urease test for Helicobacter pylori detection during endoscopy, the AUTOZYME ELISA range for autoimmune disease diagnostics, and the AMiDot® multiplex autoantibody test. All products are manufactured in-house under ISO 13485:2016 quality systems with UKCA marking and are validated for compatibility with major clinical chemistry analyser platforms from Roche, Siemens, Abbott, and Beckman.

The company monetizes through three revenue streams: direct sale of diagnostic kits and calibrators via e-commerce and global distributors (including MedScience Distribution Ltd for the UK from February 2023), contract product development and OEM/white-label supply for diagnostic and life science companies, and specialized services spanning reference lab testing, third-party quality controls, custom reagent formulation, and technical support. Customers include NHS hospitals, private laboratories, and international healthcare partners, with a global distributor network of 8+ partners. Cambridge Life Sciences operates as an associate of MedScience Group following a 2021 group partnership, with UK distribution fully consolidated under MedScience Distribution.

The business is structured around three primary use cases: clinical laboratories and hospitals requiring therapeutic drug monitoring for overdose diagnosis and routine drug level checks; gastroenterology departments needing rapid H. pylori detection during endoscopy; and immunology/autoimmune testing laboratories using ELISA-based autoantibody detection. Quantitative signal includes support for more than 1.8 million therapeutic drug monitoring tests per year. Strategic positioning emphasizes regulatory compliance, instrument-platform interoperability, and 40+ years of brand credibility as primary differentiators in a niche segment of the IVD market.

Name

Cambridge Life Sciences

Legal name

Cambridge Life Sciences Ltd

Website

https://clsdiagnostics.com

Company type

Private

Founded year

1985

Operating status

Operating

Headcount range

1–10 employees

Short description

Cambridge Life Sciences is a UK-based in vitro diagnostic manufacturer founded in 1985, producing enzymatic and ELISA assay kits for therapeutic drug monitoring, H. pylori detection, and autoimmune diagnostics, serving NHS hospitals, private laboratories, and international partners via direct sales, OEM partnerships, and a global distributor network.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical and Diagnostic Laboratories (62151)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)

akta.pro primary industry

Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI)

akta.pro secondary industries

IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM), Quality Control, Calibrators, Standards & Proficiency Testing (IVD Consumables) (HLAHAAAL), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB), Biomarker Assay & Reagent Development (LDT/IVD assay design, antibodies/standards/controls) (HLAAAMAL)

Keywords

• In vitro diagnostics
• Therapeutic drug monitoring
• Autoimmune diagnostics
• Clinical chemistry assays
• Diagnostic manufacturing

Headquarters

HQ city

Cambridge

HQ country

United Kingdom

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic Products Sales: Sale of therapeutic drug monitoring kits (Paracetamol, Salicylate), autoimmune ELISA assays, and rapid H. pylori tests. Products include assay kits, calibrator kits, and reagents sold directly or through distributors.
2. Contract Product Development & OEM Supply: End-to-end development of diagnostic products from concept to commercialisation for organisations seeking to design, formulate, and produce diagnostic assays. Flexible partnership models including co-development, OEM, or white-label arrangements.
3. Specialised Services: Reference lab services, quality control services, technical support solutions, and tailored support services provided to laboratories and diagnostic facilities.

Pricing tiers

Go-to-market motion3 records

Distribution channels3 records

Marketing channels5 records

Core offering

Cambridge Life Sciences develops, manufactures, and distributes in vitro diagnostic assay kits and reagents for clinical laboratories. Its product portfolio includes therapeutic drug monitoring assays (Paracetamol and Salicylate kits), the Endosc-HP® rapid urease test for Helicobacter pylori detection during endoscopy, the AUTOZYME ELISA range for autoimmune disease diagnostics, plus associated calibrators and specialised services such as contract product development, OEM/white-label supply, custom reagent formulation, reference lab services, and third-party quality controls. All products are manufactured in the UK under ISO 13485:2016 certified quality systems and validated for use with major clinical chemistry analysers (Roche, Siemens, Abbott, Beckman).

Product overview

Cambridge Life Sciences develops, manufactures, and distributes innovative in vitro diagnostic products as a unified portfolio of diagnostic assays, reagents, and laboratory services. The product suite comprises: (1) Therapeutic Drug Monitoring assays including Paracetamol (K8003/K8004) and Salicylate (K9001) assay kits with corresponding calibrators; (2) Rapid Helicobacter Pylori Test (Endosc-HP®); (3) AUTOZYME ELISA range for autoimmune diagnostics; and (4) specialised services including Custom Reagents & Formulations, Third Party Quality Controls, Contract Product Development, Reference Lab Services, Technical Support Solutions, and Tailored Support. All products are manufactured in the UK under ISO 13485:2016 certified quality systems and are validated for compatibility with major clinical chemistry analysers (Roche, Siemens, Abbott, Beckman). The portfolio serves NHS hospitals, private laboratories, and international partners through a global distribution network.

Differentiator

Problem solved

Functional benefit

Brands

• AUTOZYME ELISA: Highly sensitive and specific enzyme-linked immunosorbent assays for autoimmune disease diagnosis and monitoring.
• Endosc-HP®
• AMiDot®

Products and services

• Paracetamol Liquid (Acetaminophen) Assay Kit (K8004) Liquid ready-to-use in vitro diagnostic enzymatic/colorimetric assay for quantitative measurement of Paracetamol (acetaminophen) concentration in human serum or plasma, used by clinical laboratories for therapeutic drug monitoring and overdose diagnosis. Contains approximately 1000 tests per kit and is compatible with major clinical chemistry analysers.
• Endosc-HP® Rapid Urease Test (U1021) In vitro diagnostic assay for rapid detection of Helicobacter pylori from gastric biopsy samples during endoscopy. Uses a twin-well cartridge containing urea, phenol red, and buffer salts; produces a color change from yellow to magenta within minutes. Room temperature-stable; each kit contains four ready-to-use tests.
• AUTOZYME ELISA Range Highly sensitive and specific enzyme-linked immunosorbent assays for the diagnosis and monitoring of autoimmune diseases. Detects autoantibodies across all three isotypes (IgA, IgM, IgG) and is compatible with standard ELISA platforms. Developed in-house under ISO-certified quality systems.
• Custom Reagents & Formulations Tailored chemical and biological reagents designed to meet specific research and diagnostic requirements. Includes fully customisable formulations, OEM and white-label supply options, and formulation consultation services for laboratories and healthcare organisations.
• Third Party Quality Controls Independent, high-quality control materials designed to validate the accuracy and reliability of diagnostic and analytical systems. Manufactured independently to provide true third-party verification and are compatible with multiple assay platforms and instruments.
• Contract Product Development End-to-end development of diagnostic and research products from concept to commercialisation. Includes R&D support, assay design, reagent formulation, product optimisation, and flexible partnership models such as co-development, OEM, or white-label arrangements.
• Reference Lab Services Independent laboratory testing and validation services covering assay validation, method comparison, proficiency studies, and product performance verification using state-of-the-art instrumentation and accredited methodologies.
• Technical Support Solutions Comprehensive hands-on guidance across assay implementation, troubleshooting, and product optimisation. Includes on-site or remote assistance, customised training, and protocol development for laboratories and diagnostic companies.
• Salicylate Enzyme Assay Kit (K9001) Enzymatic/colorimetric in vitro diagnostic assay for quantitative measurement of Salicylate concentration in human serum or plasma. Uses Salicylate Hydroxylase to catalyse conversion of salicylate and NADH to catechol and NAD+, with absorbance decrease at 340nm proportional to Salicylate concentration. Compatible with Roche, Siemens, Abbott, and Beckman clinical chemistry analysers and manual spectrophotometric methods.
• Salicylate Standard Calibrator Kit (K7107) Standard calibrator kit for use with Salicylate assays, providing traceable reference materials for accurate quantification of salicylate in clinical samples.
• Paracetamol Sera Calibrator Kit (K8100) Sera-based calibrator kit for Paracetamol assays providing traceable reference materials in human serum matrix for accurate quantification of paracetamol in clinical samples.
• Paracetamol Aqueous Calibrator Vial (K7101) Aqueous calibrator vial for Paracetamol assays providing traceable reference materials in aqueous matrix for accurate quantification of paracetamol in clinical samples.

Quantifiable outcome

• 1.8 million+ therapeutic drug monitoring tests conducted annually
• +2 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration4 records

Feature5 records

Partnerships

Four partnerships are on record, tiered core and minor.

• MedScience Distribution LtdcoreChannel Partner/ Reseller/ Distributor · 1 February 2023From 1st February 2023, Cambridge Life Sciences partnered with MedScience Distribution Ltd to take over all UK distribution, support, and customer service. This partnership ensures stronger reach, infrastructure and service in the UK market, with MedScience providing logistics, sales, and customer support capabilities alongside Cambridge Life Sciences' manufacturing excellence.
• MedScience GroupcoreStrategic or Co-development Partner · 1 January 2021In 2021, Cambridge Life Sciences became part of a larger group (MedScience Group), embedding its diagnostic strengths within a broader healthcare network. By 2025, Cambridge Life Sciences is fully positioned alongside MedScience Distribution as associates of MedScience Group.
• UK NEQAS (UK National External Quality Assessment Service)minorStrategic or Co-development PartnerCambridge Life Sciences partners with UK NEQAS, the UK's national external quality assessment service, to ensure diagnostic accuracy and participate in quality assurance programs for clinical laboratories.
• British In Vitro Diagnostics Association (BIVDA)minorStrategic or Co-development PartnerCambridge Life Sciences is a member of BIVDA, the UK's leading IVD industry association representing 97% of the in vitro diagnostics industry. This membership provides industry representation and networking opportunities.

Scale indicators5 records

Recent moves9 records

Expansion highlights4 records

Market position

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

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 Cambridge Life Sciences