The HTLV pathology service will support the diagnosis, prognosis and<br/>monitoring of:<br/><br/>• HTLV infection with the provision of assays to detect, type and<br/>quantify HTLV infection, and<br/>• HTLV associated diseases particularly detection of high risk for or<br/>early disease and the monitoring of interventions to inform disease<br/>management.

This is a Provider Selection Regime (PSR) confirmation of contract award notice. This contract has been awarded under the Health Care Services (Provider Selection Regime) Regulations 2023. For the avoidance of doubt, the provisions of the Public Contracts Regulations 2015 do not apply to this award.'<br/>Decision makers details are followed, no conflict of interests were declared:<br/>Gemma Fahey -Senior Sourcing Manager, Simon Rooney - Senior Sourcing Manager, Nicola Sinnett - Head <br/>of Category – Diagnostics and Pathology, Keith Hinchcliffe - Category Director, Gillian Stevens - Operational Lead, Patricia Reyes - Director of Operations, Alexandra Bowyer - Finance Business Partner and Jazz Thind - Chief Financial Officer.

The HTLV pathology service will support the diagnosis, prognosis and<br/>monitoring of:<br/><br/>• HTLV infection with the provision of assays to detect, type and<br/>quantify HTLV infection, and<br/>• HTLV associated diseases particularly detection of high risk for or<br/>early disease and the monitoring of interventions to inform disease<br/>management.<br/>An award has been made under PSR direct award process A.<br/>Total contract value of £376,268.00 between 05/10/26-04/10/28.

Public Contracts Regulations 2015 (Directive 2014/24/EU)

Award procedure without prior publication of a call for competition The Molecular Diagnostic Unit (MDU) at Imperial College London <br/>is the only capable provider. <br/>The MDU provides NCHR with bespoke diagnostic assays that <br/>have been developed and validated for NCHR by the Section of <br/>Virology for patient benefit. These assays are essential for the <br/>assessment of HTLV-1-associated disease risk and are used to <br/>determine the frequency of clinic visits, (optimizing the use of <br/>clinical services), detect and allow early treatment of HTLV-1<br/>associated disease and monitor treatment responses. <br/>Continued provision of these assays by the MDU is justified on <br/>the following grounds: <br/>• The assays were developed by the MDU as part of the <br/>HTLV National Service provision. <br/>• The assays are either only available in the UK at the <br/>MDU (HTLV proviral quantification) or are only available <br/>in the World at the MDU (HTLV Clonality Assay). <br/>• The assays would not have been developed without the <br/>partnership between ICHNT/ICL. <br/>• Samples sent for proviral load quantification are stored <br/>viably to allow access to cells for the HTLV clonality <br/>Assay later (once the proviral load is known). <br/>• The MDU is uniquely placed to provide interpretation and <br/>clinical support. <br/>• All patients in England receive the same standard of care, which <br/>is world leading. The Direct Award Process A justification is <br/>based on the provider’s specialist HTLV assay capability, <br/>validated methodology, continuity of stored viable samples, <br/>UKAS-accredited laboratory provision, and clinical integration <br/>with the National Centre for Human Retrovirology. (Supporting <br/>evidence available and retained to demonstrate that there is no <br/>realistic alternative provider for the full requirement)

Lot 1: Bids: 1