diagnostics.ai

What diagnostics.ai does

diagnostics.ai (formerly Azure PCR) is a UK-based private company founded in 2009 that builds AI-powered software for automated analysis of real-time PCR (polymerase chain reaction) diagnostic data. Its core product, PCR.AI, applies patented shape-based curve recognition machine learning to interpret fluorescence amplification curves and applies quality control rules including Westgard checks, Levey-Jennings monitoring, and cross-contamination validation, achieving over 99.9% interpretation accuracy validated across more than 250,000 samples at multiple independent clinical sites. The platform is CE-IVDR certified and MHRA registered as a Class A medical device, ISO 27001 accredited, and HIPAA compliant, supporting deployment across NHS trusts, commercial diagnostic laboratories, and OEM partners.

The product portfolio spans four components: the Integrated Workbench (full laboratory workflow management), the AI Analysis Engine API (CE-IVDR certified programmatic access for OEM and developer integration), Device Manager (centralized monitoring of PCR instruments across manufacturers including Bio-Rad, Roche, Thermo Fisher, Qiagen, and ABI), and the underlying PCR.AI analysis engine. Revenue is generated through tiered subscriptions: Device Manager on monthly volume-based billing, Enterprise Edition on multi-year contracts with deployment-based pricing and dedicated technical account management, and OEM/embedded licensing on volume-based API agreements with long-term partnership terms. The company serves clinical diagnostic laboratories, NHS and hospital labs, and diagnostic equipment manufacturers, with a horizontal segmentation approach targeting enterprise laboratory customers through direct field sales.

The company operates with a lean team of 1–10 employees from London, is founder-owned with no disclosed institutional funding, and is led by CEO/CTO Aron Cohen, Founding Director Ze'ev Russak (40+ patents in digital processing), President David Nitsan, and Chairman Prof Brian Glenville. Geographic footprint covers the United Kingdom and United States, with commercial validation from Quest Diagnostics, multiple NHS trusts including NHS Greater Glasgow & Clyde and NHS Kings College Hospital, and peer-reviewed clinical studies published in the Journal of Clinical Virology and Journal of Virological Methods.

Name

diagnostics.ai

Legal name

Diagnostics.ai Ltd

Website

https://diagnostics.ai

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

1–10 employees

Short description

diagnostics.ai builds CE-IVDR certified AI software that automates real-time PCR result interpretation, quality control, and LIMS integration for clinical diagnostic laboratories, NHS hospital labs, and diagnostic equipment OEM partners in the UK and US.

Ownership category

akta.pro rank

Product category

Clinical Laboratory Diagnostics Software

NAICS

Software Publishers (513210)

SIC

Laboratory Analytical Instruments (3826)

akta.pro primary industry

SaMD – Imaging & Signal Analysis (AI/ML) (HLACANAG)

akta.pro secondary industry

Digital & AI-Enabled Diagnostics (algorithmic interpretation, decision support tied to assays) (HLAAALAO)

Keywords

• PCR curve analysis
• Molecular diagnostics software
• QPCR result interpretation
• Clinical laboratory automation
• Laboratory quality control

Headquarters

HQ city

London

HQ country

United Kingdom

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

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

Revenue model

1. Device Manager Subscription: Cloud-based subscription model for Device Manager with pricing based on testing volume. Includes standard email support with defined SLAs.
2. Enterprise Edition: Enterprise deployment with pricing based on deployment scope and implementation services. Includes priority support with faster response times, phone support, and dedicated Technical Account Manager.
3. OEM/Partner API Model: Volume-based API access model for OEM integration partners, software developers, and diagnostic equipment providers. Long-term partnership agreements with flexible commercial terms.
4. API Services: Pure API access for integration without interface components. OEM Partner API services offer 99.9% availability SLAs.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

Diagnostics.ai sells CE-IVDR certified AI-powered software that automates the interpretation, quality control, and reporting of real-time PCR data for clinical diagnostic laboratories. The platform analyzes fluorescence curves using shape-based pattern recognition (hundreds of data points per curve) to deliver over 99.9% interpretation accuracy, automated Westgard/Levey-Jennings QC, and bidirectional LIMS integration. Offerings are delivered as a SaaS workbench, an OEM/embedded API, and a centralized device-monitoring module.

Product overview

Diagnostics.ai offers a modular AI-powered molecular diagnostics platform consisting of PCR.AI as the primary product, with three integrated components: the Integrated Workbench for comprehensive laboratory workflow management, the AI Analysis Engine (PCR.AI API) for programmatic OEM integration, and Device Manager for centralized PCR platform monitoring. The platform provides end-to-end capabilities from thermocycler file import through automated AI analysis, quality control, LIMS integration, and compliance monitoring.

Differentiator

Problem solved

Functional benefit

Brands

• PCR.AI: AI-powered automated PCR diagnostic interpretation platform with over 99.9% accuracy for real-time PCR curve analysis, quality control, and reporting.
• Integrated Workbench
• AI Analysis Engine (PCR.AI API)
• Device Manager

Products and services

• PCR.AI CE-IVDR certified AI-powered platform that automates the analysis, quality control, and reporting of real-time PCR data. Uses machine learning to interpret fluorescence curves, applies Westgard rules, and generates standardized reports at >99.9% interpretation accuracy for clinical diagnostic laboratories.
• Integrated Workbench Complete end-to-end laboratory management platform integrating AI-powered curve analysis, advanced rules engine and QC (repeats and Westgard rules), flexible LIMS integration for fully-automated resulting, and device monitoring and data management for clinical diagnostic laboratories.
• AI Analysis Engine (PCR.AI API) CE-IVDR and MHRA registered Class A medical device software providing pure RESTful API access for programmatic integration. Designed for OEMs, software developers, LIMS vendors, and diagnostic equipment providers, with raw run file parsing for any qPCR file format and transparent AI learning, tuning, and inferencing.
• Device Manager Centralized web-based management and monitoring solution for all laboratory PCR devices. Connects sample-to-answer platforms and laboratory-developed tests (LDTs), reviews data across multiple devices, provides integrated trends and alert monitoring, and allows tests to be adapted to follow laboratory-defined rules.

Quantifiable outcome

• Over 99.9% interpretation accuracy validated in clinical studies
• +4 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

Integration5 records

AI capability4 records

Feature9 records

Scale indicators6 records

Recent moves5 records

Expansion highlights5 records

Broad incumbents

• Bio-Rad Laboratories: Bio-Rad's CFX family of real-time PCR systems is supported by diagnostics.ai's integration; Bio-Rad's CFX Maestro software and broader life-science research portfolio put it in adjacent competition for lab AI interpretation work.
• Roche Diagnostics: Roche manufactures the LightCycler qPCR systems that diagnostics.ai integrates with and offers its own analysis software; it competes in CE-IVDR regulated molecular diagnostics and could bundle competing AI with its thermocycler installed base.
• Thermo Fisher Scientific: Thermo Fisher's QuantStudio qPCR platforms and Design & Analysis software target the same diagnostic and research labs as diagnostics.ai; its scale, cloud platform, and AI investments make it a credible threat to bundle competing AI interpretation.
• BioMérieux: BioMérieux's BioFire molecular diagnostic systems operate in regulated IVD workflows overlapping with diagnostics.ai's NHS and hospital lab customers; its scale in clinical microbiology diagnostics makes it a strategic alternative or partner.
• Cepheid (Danaher): Cepheid's GeneXpert sample-to-answer molecular diagnostic systems serve hospital and clinical labs — comparable customer profile to diagnostics.ai — and Danaher's broader diagnostic platform ambitions could include competing AI interpretation.
• QIAGEN: QIAGEN's QIAquant and Rotor-Gene Q PCR systems are directly supported by diagnostics.ai's integration; QIAGEN also offers sample-to-result molecular workflows and could expand its own AI interpretation layer into CE-IVDR regulated diagnostics.
• Siemens Healthineers: Siemens Healthineers operates a broad clinical diagnostics portfolio (including molecular and lab automation) that serves many of the same regulated hospital and reference lab customers as diagnostics.ai and could build or acquire AI interpretation capabilities.

Direct peers

• SOPHiA GENETICS: SOPHiA GENETICS builds an AI platform for clinical genomics and molecular diagnostic interpretation, serving hospital and reference labs via subscription and OEM partnerships — directly comparable to diagnostics.ai's position as an AI interpretation layer for molecular diagnostic data.

Emerging players

• DNAnexus: DNAnexus provides a cloud platform and APIs for genomic and clinical diagnostic data analysis with OEM-style enterprise access — comparable to diagnostics.ai's API-first OEM/embedded distribution model for molecular data interpretation.
• Fabric Genomics: Fabric Genomics applies AI/ML to clinical genomic and NGS variant interpretation for hospital labs — overlapping with diagnostics.ai's mission of algorithmic interpretation of molecular diagnostic data, though it focuses on sequencing rather than qPCR.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/diagnosticsai
• LinkedInlinkedin.com/company/azure-pcr

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

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 diagnostics.ai