Molecular Equipment, Transfer, Commissioning and Maintenance Services for the new children’s hospital

Type of Contract: Supplies (incl. services) Description: This is a voluntary ex ante transparency (VEAT) notice. This notice acknowledges that CHI proposes to contract with Thermo Fisher Scientific Ireland Ltd for the supply, transfer, commissioning, maintenance and continued provision of support for primarily existing molecular equipment and the addition of specialist equipment to enable the service to continue providing paediatric diagnostics nationally. The contract includes the provision existing and new equipment for Molecular Histopathology and Microbiology for the setup, processing and resulting of tests. The following sections highlight the reasons for the requirement of the specialist equipment. The Oncomine Childhood Cancer Research Assay (OCCRA) is a comprehensive, targeted NGS assay designed to assist researchers in the understanding of childhood and young adult cancer. OCCRA was designed and manufactured by Thermo Fisher Scientific for research use only. Molecular Histology includes the OCCRA DNA and RNA panels described above, which are part of comprehensive in-house validated test procedures, permitting one-assay approaches to ancillary diagnosis, prognostication and increasingly also need for theranostics on the paediatric solid tumour samples that come through CHI, the only paediatric oncology centre for children in Ireland. There is currently an agreement to proceed with an SLA for the Northern Irish paediatric cancer samples to be handled by the CHI laboratory. As the RNA fusion panel also covers all fusion transcripts identified in sarcomas, be they adult- or paediatric-type sarcomas, CHI have furthermore been in a position to critically support in the diagnosis and care of adult sarcoma patients whose biopsies have been referred from several of large teaching hospitals around in the country. CHI in-house validated Oncomine Childhood Cancer Research Assay (OCCRA) panels, while including all sarcoma-relevant molecular genetic findings, were developed to increase understanding of paediatric solid tumours and indeed do allow us to comprehensively interrogate for all relevant fusions, copy number changes, SNVs and indels relevant to paediatric solid tumours and propose optimal treatment of these patients from diagnosis and at relapse. As the Oncomine Childhood Cancer Research Assay (OCCRA) panel runs on the S5 platform only, other platforms are not taken into consideration at this point, as no other platforms have this comprehensive capability and it is not possible to piece together assays on other alternative platforms to achieve the same range of molecular genetic tests to cater to the requirements of CHI cancer patients. Additionally, the Irish Meningitis and Sepsis Reference Laboratory based at CHI at Temple St and the Molecular Microbiology Laboratory at CHI at Crumlin run a series of in-house developed INAB accredited tests for the diagnosis of a variety of infections. All of these tests were developed, validated, and run routinely on Thermo Fisher Scientific real-time PCR instruments. Changing from current Thermo Fisher Scientific technology to an alternative technology during the transfer and commissioning into the new children’s hospital would not be possible due to the onerous and extensive revalidation requirements of these tests, which include a high risk that the tests would not achieve acceptable results as compared to the test in use on Thermo Fisher platforms that will transfer and be upgraded into the new children’s hospital. In summary, there are no technically, clinically, financially or administratively reasonable or viable alternative or substitute solutions that could be implemented other than transferring the existing and if required, complement or replace with new Thermo Fisher platforms, that can meet the requirements of CHI for the aforementioned service and diagnostic testing.