PROVISIONS OF PCR MASTER MIXES – CLONALITY TESTING

Procurement reference

CAV-DCO (25-26) 99

Procurement 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

Cardiff and Vale University Health Board

Invivoscribe technologies SARL

Procedure type

Direct award

Description of how these justifications apply

The requirement relates to a highly specialised product/service where only a limited number of suppliers in the market can meet the necessary technical and clinical requirements. The selected supplier provides a defined solution that is compatible with existing systems and meets specific performance standards. Due to these technical constraints and the need for continuity of service, no alternative supplier is capable of delivering the required specification without significant disruption or risk

Direct award justification

Single suppliers technical reasons