C253996 DHSC NHS Human Leucocyte Antigen Typing - Advanced Rapid High Resolution

The Department of Health and Social Care is issuing this Prior Information Notice (PIN) to inform the market of an early market engagement exercise, available to any organisations which have expertise in the provision of HLA typing assays for the purposes of clinical use in organ transplantation.

The purpose of the exercise is to inform the Implementation Steering Group for Organ Utilisation (ISOU) Histocompatibility & Immunogenetics Sub-Group about the future direction and capabilities of assays which produce a high resolution HLA type of organ donors for transplantation purposes.

This information will then be used to form recommendations within the ISOU framework and guide the future direction of HLA typing of organ donors in the UK.

This exercise seeks to engage with the market to enable the ISOU subgroup to: Primary Requirement: 1.

Understand the commercial assays capable of rapidly producing a type for HLA-A,B,C,DRB1/3/4/5, DQB1, DQA1, DPB1, DPA1 with a resolution of 2nd field (minimum).

Currently the timeframe allocated for deceased donor typing is set at 4 hours, however this timeframe may be slightly relaxed in future, if for example a slightly longer timeframe produces a higher resolution type or clinically relevant information extending beyond the HLA loci is obtained.

The ISOU subgroup seeks to understand the assays and technologies which are currently available or will be brought to market in timeframe of 5 years which can fulfil the above remit.

Secondary Requirements: 2.

Availability of IT solutions for direct transfer of donor HLA typing results, including the use of Histoimmunogenetics Markup Language (HML) where appropriate, which would support the primary requirement.

3.

Demonstrate compliance with in vitro diagnostic medical devices regulations (IVDR) for typing assays and software as required.

4.

Indicate if typing beyond the HLA loci is being considered / developed with the capabilities of assays designed for rapid high resolution HLA typing. e.g. inclusion of HNA or MICA typing.

Market Engagement Event will take place virtually on Friday 5th July 2024 Please register your interest below no later than 17:00 Friday 31st May https://forms.office.com/e/WUxAMxbUkT This PIN may result in a future procurement for the Provision of HLA typing assays that can produce an HLA type to the 2nd field (minimum) within a 4 hour period.

The assay may not be currently available but should be implementable within a five to ten year time frame.

However, at this time we have no commitment to spend, this is an activity to scope the market only.