IVD testing laboratory in Doncaster, UK
Where your samples are tested matters as much as how.
Doncaster facility
A laboratory dedicated to IVD testing
Our laboratory in Doncaster is dedicated to performance evaluation and testing work, with a specialism in in vitro diagnostics (IVDs), controlled sample receipt, storage and data handling. With excellent transport links, the site supports sponsors across the UK and EU, with US projects delivered via Abingdon Health’s commercial office and laboratory in Madison, Wisconsin.
Capability and quality
Our laboratory
Laboratory capability
Laboratory zones include analytical testing laboratories, sample storage areas, environmental chamber facilities, cold-storage areas, and associated supporting quality-controlled laboratory workspaces. Equipment is calibrated and maintained under our ISO 17025 quality system, with records linking each result to the instrument, method, reagent lot and analyst.
Sample management
Specimens are received, logged and stored under documented chain of custody protocols, in dedicated, secure temperature-monitored storage covering a wide array of ranges, for example -80°C, -20°C and 2 to 8°C. Every sample batch is traceable from receipt to disposal, protecting the integrity of your data.
Quality system
Our quality management system will control documents, training, deviations and corrective action, with internal audits and management review built in. Clients are welcome to audit the laboratory before and during their study.
Equipment
Core instrumentation and laboratory platforms
Microplate luminometer system
Refrigerated centrifugation systems
Environmental and stability chambers
Biological safety cabinet facilities
Microplate washing and incubation equipment
Environmental monitoring systems
Refrigerated, frozen and ultra-low temperature sample storage infrastructure
People
Our team
The laboratory is headed up by Dr Baranse Ozturk, Site Lead, and Liz Lees, Clinical Performance Lead, supported by our quality assurance team, performance evaluation leads, clinical trial manager and scientists experienced in immunoassay, molecular and lateral flow testing. Chris Yates, President & CCO, and Candice Vendettuoli, Director, lead commercial and project delivery, supported by our Senior Clinical Programme Manager.
Our group
Part of Abingdon Health plc
As part of Abingdon Health plc (AIM: ABDX | OTCQB: ABDXF), an IVD developer and contract manufacturer, we bring extensive experience of a CDMO’s approach to device design, technical transfer, scale-up and commercial timelines.
Our independence and objectivity as an accredited test house are safeguarded through robust management controls and a documented impartiality framework. We enforce a strict separation between technical testing operations and commercial management.
From the Knowledge Centre
Read more on Doncaster facility
Practical guidance from the specialists who deliver this work every day.
Article
Performance Evaluation for FDA 510(k): Building Your Substantial Equivalence Case
What FDA 510(k) performance evaluation requires and how to build a strong case for substantial equivalence in IVD submissions.
Also worth reading
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Article
Breaking Down Analytical Performance Studies under IVDR: Methodologies and Best Practices
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Guide
Abingdon Analytical Performance Evaluation Brochure
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Article
Analytical Performance and Clinical Evaluation: synchronised for success
Frequently asked questions
Doncaster facility FAQs
The Doncaster facility supports organisations developing diagnostics, medical devices and healthcare technologies through laboratory testing, evidence generation and product development activities. These services can support regulatory, analytical and commercialisation programmes throughout the product lifecycle.
The Doncaster facility operates an ISO/IEC 17025 accredited laboratory, demonstrating technical competence and recognised quality processes for laboratory testing activities. Accreditation provides confidence in the reliability and traceability of testing data used to support development and regulatory objectives.
Testing and evidence generated at the Doncaster facility can support technical documentation, performance evaluation activities and regulatory submissions. Robust laboratory data can help manufacturers prepare for FDA submissions, MDR compliance and IVDR requirements.
Yes. The facility supports assay development, assay optimisation and validation activities for diagnostics and in vitro diagnostic products. These studies help organisations generate the evidence required for product development, performance evaluation and regulatory review.
The facility supports startups, scale-ups and established organisations developing medical devices, diagnostics, digital health technologies and related healthcare products. Services can be tailored to organisations at different stages of product development, from early feasibility studies through to regulatory submission readiness.
Start the conversation
Discuss your Performance Evaluation study
Tell us about your device, its intended purpose and the markets you are targeting, and we will map the studies your submission needs.
- ISO/IEC 17025 accredited (UKAS 32723)
- CLSI, ICH and ISO referenced protocols
- Evidence for IVDR, UKCA and FDA