TISSUE ANALYSIS
Immunohistochemistry
H&E, PD-L1, HER2, P10, CLDN-18, MTAP, P16, KRAS
Health Institution & ARC Laboratories
Following consultation with the UK MHRA, ARC Laboratories meets the definition of a Health Institution under the IVDR framework. Northern Ireland’s unique position under this framework enables ARC to support eligible UK and EU clinical trial testing through the Article 5(5) Health Institution pathway.
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ARC Laboratories provides specialist laboratory services to support clinical trials, precision medicine programmes, and diagnostic development across the UK, Europe, and global markets. Combining scientific expertise with regulatory understanding, we help sponsors generate high-quality data, reduce complexity, and accelerate study delivery.
Our in-house laboratory capabilities support a wide range of testing requirements, from biomarker and molecular analysis to clinical trial sample management and specialised diagnostic services. By integrating laboratory operations with clinical, regulatory, and project delivery expertise, we provide a seamless experience from study start-up through to final reporting.
Following consultation with the UK MHRA, ARC Laboratories has self-designated as a UK Health Institution under the IVDR Health Institution Exemption. This enables compliant testing of both UK and EU clinical trial samples, providing sponsors with greater flexibility, reduced timelines, and enhanced support for precision medicine and diagnostic-led studies.
Supported by robust quality systems and internationally recognised standards, ARC Laboratories delivers reliable results underpinned by quality and trusted by sponsors.
Following consultation with the UK MHRA, ARC Laboratories meets the definition of a Health Institution under the IVDR framework applicable in Northern Ireland. This enables eligible UK and EU clinical trial samples to be tested in accordance with the Article 5(5) Health Institution Exemption.
For sponsors, this provides an alternative pathway for eligible precision medicine and diagnostic-led clinical trials, helping to reduce administrative burden, support faster study initiation and, where applicable, avoid the need for a formal performance study application while maintaining compliance with relevant IVDR requirements.
Health Institution Status
IVDR Article 5(5)
UK & EU Clinical Trial Testing
Faster Study Start-Up
* This document outlines how ARC Laboratories, in its capacity as a Health Institution offering testing for precision medicine clinical trials, meets the applicable requirements set out under IVDR Article 5(5).
The Health Institution Exemption provides an alternative pathway for eligible precision medicine and diagnostic-led clinical trials. By reducing regulatory complexity and streamlining testing, ARC Laboratories helps sponsors accelerate study delivery while maintaining compliance with the IVDR framework.
Commitment to Quality
ARC is committed to delivering accurate, reliable, and high-quality testing services through technical excellence and a robust ISO 13485 and ISO 14971 compliant quality management system. We maintain globally recognised medical laboratory accreditations, including ISO 15189 (UKAS awarded) and College of American Pathologists (CAP), with all laboratory processes also GCP and GLP compliant.
UKAS-awarded accreditation for medical laboratory quality and competence.
College of American Pathologists accreditation supporting international laboratory standards.
Our commitment to accurate, reliable, compliant, and continuously improving laboratory services.
Key services
From assay validation and revalidation through to clinical trial testing and regulatory support, ARC Laboratories helps sponsors generate reliable evidence for precision medicine and diagnostic-led studies.
Transfer your in-house biomarker assays to ARC Laboratories and generate robust analytical performance data to support regulatory requirements, including US FDA IDE submissions and EU IVDR compliance.
Efficiently move assays from Research Use Only (RUO) status to Investigational Use Only (IUO), while generating the evidence required for IVDR compliance across new sample types, indications, and clinical applications.
Design and execute laboratory-to-laboratory reproducibility studies to demonstrate assay robustness, support diagnostic manufacturers, and generate the evidence needed for successful product commercialisation.
Conduct clinical testing within accredited UK and EU laboratory environments under Health Institution Exemption pathways, enabling early-phase clinical studies without the immediate need for full IVDR regulatory approval.
Comprehensive support for IVDR performance evaluation studies, including study design, regulatory strategy, evidence generation, technical documentation, and submission readiness and of course clinical testing.
ARC Laboratories offers a growing portfolio of validated Health Institution Exemption (HIE) assays to support precision medicine, companion diagnostics, and clinical trial programmes. Download the relevant user guide below or contact our laboratory team to discuss additional biomarkers and assay development requirements.
H&E, PD-L1, HER2, P10, CLDN-18, MTAP, P16, KRAS
EGFR
AAV-9
MSK-Impact- Flex (MTAP), NGSgo®-MX6-1 HLA (HLA-A, HLA-B, HLA-C, HLA-DRB1, HLA-DQB1, HLA-DPB1)
People who put patients first
Meet the team dedicated to guiding you through complex healthcare regulations with clarity, empathy, and expertise. Our multidisciplinary team brings together laboratory scientists, quality specialists, and regulatory experts with extensive experience supporting precision medicine, companion diagnostics, and clinical trial programmes.
Working collaboratively with sponsors, we deliver the scientific expertise, technical excellence, and regulatory confidence needed to advance innovative diagnostics.
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Founder with 17 years’ experience leading IVD design engineering projects globally.
Pharma leader with 10 years’ experience managing IVD clinical research programmes.
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Chartered Accountant with 10+ years’ experience leading finance and governance functions.
10+ years’ experience delivering digital products across healthcare, data and regulated industries.
Brings over 10 years’ experience in clinical, quality and regulatory consulting for global precision medicine studies.
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30+ years’ expertise in people leadership, organisational development and culture.
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9 years assay development & validation experience. 3 years early phase clinical trials.
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20+ years’ expertise in global regulatory affairs and clinical compliance across pharmaceuticals and diagnostics.
12+ years of experience in diagnostics, clinical trials, NGS, and biomarker discovery.
Research operations leader experienced in diagnostics, pharmaceuticals, quality assurance, and project management.
Research operations leader experienced in diagnostics, regulated laboratories, biomarkers, and project delivery.
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Quality leader with 20+ years’ experience in regulated healthcare environments.
Chartered Biologist experienced in laboratory operations, technical management, quality, and regulatory compliance.
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IVD specialist with 14 years’ experience developing small molecules and ADA programmes.
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10 years commercial experience across pharma, sterile IV manufacturing and precision diagnostics.
ARC Laboratories collaborates with leading technology providers to deliver high-quality laboratory services and support precision medicine, companion diagnostics, and clinical trial programmes. Our partnerships enable access to validated platforms, innovative technologies, and trusted scientific expertise.
Discover the latest insights, laboratory innovations, and practical guidance from ARC specialists.
We provide specialist laboratory testing for precision medicine, companion diagnostics, biomarkers, and clinical trial programmes.
It provides a compliant pathway for eligible clinical trial testing under Article 5(5) of the IVDR framework.
Yes. We support eligible UK and EU clinical trial testing through our Health Institution designation.
Download user guides from the Available Assays section or contact our laboratory team for assistance.
No. We only perform testing linked to approved clinical trials organised by study sponsors or clinical sites.
Use the contact form or email arclabs@arc-regulatory.co.uk. We aim to respond within 48 business hours.
Connected Programme Support
ARC brings together regulatory, clinical, laboratory and technology expertise to support diagnostic programmes from development through delivery.
For laboratory enquiries, study-related testing questions, complaints, or feedback, please contact ARC Laboratories directly.
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