Purchase of DPYD (dihydropyrimidine dehydrogenase) testing kits

Concepts

• cardiff
• laboratory reagents
• awmgl
• purchase of dpyd
• elucigene dpyd assay
• test
• dpyd gene
• established dpyd service
• dihydropyrimidine dehydrogenase
• testing kits

Location

Cardiff and Vale of Glamorgan: All Wales Medical Genomics Service, Institute of Medical Genetics, University Hospital of Wales, Heath Park, Cardiff, CF14 4XW

Description

All Wales Genomics Laboratory (AWMGL) has been providing testing for DPYD (dihydropyrimidine dehydrogenase) deficiency since July 2020. Germline variants in the DPYD gene can confer an increased risk of severe or fatal toxicity for cancer patients being treated with common fluoropyrimidine based chemotherapies, 5-fluoruracil and/or capecitabine. Therefore results allow clinicians to assess if the treatment is suitable for the patient. Due to considerable increase in the demand for the test the AWMGL intends to award a two year contract (for a period of 12 months with the option to extend for a further 12 months) to ensure continuity of service to the patients of NHS Wales.

Total Quantity or Scope

The test has continued to grow in demand across Wales for an established DPYD service and as a consequence AWMGL is now required to advertise their intention award a contract to Yourgene Health UK without prior advertisement. The Elucigene DPYD assay provided by Yourgene Health UK Limited is deemed the only technology suitable for meeting the lab requirements for the following reasons; The test has already been validated by the laboratory as it has been used for a number of years, therefore meets the standards required to deliver the service. A change in technology or provider would require a considerable validation process which would have considerable cost and time implications to the laboratory and would be extremely detrimental to patient care. The technology used for the test is also used for other services provided by the AWMGL. This further provides evidence that the technology is already suitable for use and also allows streamlining of in house testing. The equipment needed for the test is already in place. Change in technology may incur considerable extra costs from requirement to purchase and maintain new equipment. Elucigene DPYD assay is IVD marked; thereby future-proofing the test for any future requirements for the lab to use IVD approved technologies for this test. Test was cost assessed by the department at the point of validation and has been deemed the most cost effective method of testing (taking into consideration all the points above) NWSSP Procurement Services intends to award a contract on behalf of Cardiff and Vale University Health Board, AWMGL, for the supply of a The Elucigene DPYD assay provided by Yourgene Health UK Limited, for the unique reasons outlined above. The contract is estimated to commence in July 2021, for a period of two years (to be awarded for 12 months with the option to extend for a further 12 months) for estimated quantity of 144 kits (3600 samples) per annum. The contract will include all associated services.

Award Detail

CPV Codes

• 33696500 - Laboratory reagents

Legal Justification

All Wales Genomics Laboratory (AWMGL) has been providing testing for DPYD (dihydropyrimidine dehydrogenase) deficiency since July 2020. Germline variants in the DPYD gene can confer an increased risk of severe or fatal toxicity for cancer patients being treated with common fluoropyrimidine based chemotherapies, 5-fluoruracil and/or capecitabine. Therefore results allow clinicians to assess if the treatment is suitable for the patient. The Elucigene DPYD assay provided by Yourgene Health UK Limited is deemed the only technology suitable for meeting the lab requirements for the following reasons; The test has already been validated in the lab and is confirmed as being suitable for use. A change in technology or provider would require a considerable validation process which would have considerable cost and time implications to the lab and be extremely detrimental to patient care. The technology used for the test is also used for other services provided by the AWMGL. This further provides evidence that the technology is already suitable for use and also allows streamlining of in house testing. The equipment needed for the test is already in place and maintained. Change in technology may incur considerable extra costs from requirement to purchase and maintain new equipment. Elucigene DPYD assay is IVD marked; thereby future-proofing the test for any future requirements for the lab to use IVD approved technologies for this test. Test was cost assessed by the department at the point of validation and has been deemed the most cost effective method of testing (taking into consideration all the points above)

Other Information

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