Scope
Reference
CAV-DIR (25-26) 99
Description
The All Wales Medical Genomics Service (AWMGS) is awarding a direct contract for the supply of PCR mastermixes and associated reagents required for B and T cell clonality testing. These assays are critical for diagnosing and monitoring haematological malignancies such as lymphoma and must include validated clonal and polyclonal controls, as well as a control gene, to ensure accurate and reproducible results. In addition to product supply, the contract includes technical support to maintain continuity of service. Changing supplier would require extensive revalidation and re-accreditation of all assays, which would be a major undertaking and cause significant disruption to diagnostic services. This would lead to delays in patient testing, risking late or missed diagnoses and potentially endangering patient health and outcomes. The direct award is therefore essential to safeguard patient safety, maintain compliance with UKAS standards, and ensure uninterrupted delivery of critical genomic testing services across Wales.
Contract 1. PROVISIONS OF PCR MASTER MIXES – CLONALITY TESTING
Supplier
Contract value
- 355550.00 EUR excluding VAT
- 426659.98 EUR including VAT
Above the relevant threshold
Earliest date the contract will be signed
15 December 2025
Contract dates (estimated)
- 1 January 2026 to 31 December 2026
- 1 year
Main procurement category
Goods
CPV classifications
- 33696500 - Laboratory reagents
Contract locations
- UKL22 - Cardiff and Vale of Glamorgan
Other information
Description of risks to contract performance
The main risks to contract performance include supply chain disruption, single supplier dependency, and potential delays in delivery or technical support. These risks could impact continuity of testing and patient care. Mitigation measures include strict service level agreements, proactive communication requirements, and performance monitoring through AWMGS's Quality Management System.
Conflicts assessment prepared/revised
Yes
Procedure
Procedure type
Direct award
Direct award justification
Single supplier - technical reasons
The All Wales Medical Genomics Service (AWMGS) requires PCR mastermixes and associated reagents for B and T cell clonality testing, which are critical for diagnosing and monitoring haematological malignancies such as lymphoma. These assays must include validated clonal and polyclonal controls and a control gene to ensure accurate and reproducible results. Changing supplier would necessitate full revalidation and re-accreditation of all existing assays under UKAS ISO 15189:2022 standards-a process that is highly complex, resource-intensive, and time-consuming. This would cause significant disruption to diagnostic services, resulting in delays to patient testing and reporting. Such delays pose a serious risk to patient safety, as timely diagnosis is essential for initiating treatment and improving clinical outcomes. Any interruption could lead to missed or late diagnoses, directly endangering patient health and potentially impacting survival rates. To avoid these unacceptable risks and maintain continuity of service, a direct award is the only viable option, service resilience, and safeguarding patient care across Wales.
Supplier
Invivoscribe Technologies SARL
- Public Procurement Organisation Number: PXNH-7642-BTWQ
Zeppelinstraße 1
Hallbergmoos
85399
Germany
Small or medium-sized enterprise (SME): No
Voluntary, community or social enterprise (VCSE): No
Contract 1. PROVISIONS OF PCR MASTER MIXES - CLONALITY TESTING
Contracting authority
Cardiff and Vale University Health Board
- Public Procurement Organisation Number: PPPR-7969-BTJG
Woodland House, Maes y Coed Road
Cardiff
CF14 4HH
United Kingdom
Contact name: Nicola Williams
Email: Nicola.williams33@wales.nhs.com
Website: http://nwssp.nhs.wales/ourservices/procurement-services/
Region: UKL22 - Cardiff and Vale of Glamorgan
Organisation type: Public authority - sub-central government
Devolved regulations that apply: Wales
Other organisation
These organisations are carrying out the procurement, or part of it, on behalf of the contracting authorities.
NHS Wales Shared Services Partnership (hosted by Velindre University NHS Trust)
Summary of their role in this procurement: The NHS Wales Shared Services Partnership (NWSSP) plays a vital role in supporting NHS Wales by delivering a wide range of professional, technical, and administrative services. It is hosted by Velindre University NHS Trust, which means Velindre provides the governance and infrastructure to support NWSSP's operations, but NWSSP itself serves all NHS organisations across Wales.
- Public Procurement Organisation Number: PXWV-6492-CGMN
4-5 Charnwood Court Heol Billingsley
Cardiff
CF15 7QZ
United Kingdom
Region: UKL15 - Central Valleys