Request for information: IG/TCR clonality and somatic hypermutation assay.

Description du marché

This is not a call for tenders and does not obligate the Acquisition Unit of the Joint Authority of the Helsinki and Uusimaa Hospital District for any actions. The responses to this information request do not obligate the acquisition unit to any service acquisitions. Responding to this request for information is not a prerequisite for participation in the future procurement. Interested parties will not be prejudiced by any failure to participate in this preliminary market consultation. HUS will not charge, nor reward any costs of the market consultation. HUSLAB Laboratory of Genetics at HUS (Helsinki University Hospital) Diagnostic Center is an SFS-EN ISO 15189:2022 accredited laboratory providing diagnostic genetic testing services to all patients at Helsinki University Hospital area. The services include analysis of both constitutional samples and malignancies. The laboratory provides sequencing services mainly using multiple diagnostic laboratory processes. The laboratory performs yearly approximately 250 immunoglobulin gene rearrangement studies, 400 T-cell receptor rearrangement studies, and 100 immunoglobulin gene V-region hypermutation studies. The laboratory is currently seeking for these studies analysis kits, which can be run on either IonTorrent S5 prime instrument or Illumina NovaSeq instrument. Regarding the kit you are providing, please provide information on the following questions: 1. Is the kit compatible with Ion Torrent Ion GeneStudio™ S5 Prime instrument? Yes/No 2. Is the kit compatible with Illumina’s NovaSeq 6000 instrument? Yes/No 3. Does the kit have CE-IVD marking? Yes/No 4. Does the kit have IVDR marking? Yes/No. If yes, what risk class (A/B/C/D)? What is the intended use? Which sample types the IVDR marking covers? 5. Is there a plan to obtain IVDR marking for the kit? Yes/No 6. Is the kit validated for both paraffin-embedded and fresh tissue samples? Yes/No 7. In the kit compatible with automated DNA extraction method (Maxwell/Qiasymphony)? 8. Which gene regions does the kit cover for T-cell receptors (TCRA, TCRB, TCRG, TCRD)? Are these regions analyzed in the same or separate amplification reactions? 9. Which gene regions does the kit cover for immunoglobulins (IGH, IGK, and IGL)? Are these regions analyzed in the same or separate amplification reactions? 10. Does the kit cover both complete and incomplete rearrangements? 11. Does the hypermutation kit cover the entire V gene segment (primers on the leader region), and if not, what proportion of the V gene region can be examined? 12. How many index/barcode sequences are available for the kit? 13. Is it possible to combine immunoglobulin rearrangement, T-cell receptor rearrangement and hypermutation samples on the same sequencing chip/flow cell? 14. Does the kit include in-tube quality control, which can be used to correct the number of sequencing reads per input molecule to get exact estimation of the clonal abundance? 15. What is the sensitivity of the method, when performed in the diagnostic phase? 16. How many samples can be analyzed per chip (530/540/550) or flow cell (SP) when studying diagnostic phase samples? 17. Can the method provide clonal rearrangement sequence information for minimal residual disease (MRD) monitoring purposes? Yes/No 18. Can the method be used for MRD monitoring, and what is the sensitivity in that case? 19. How many samples can be analyzed per chip (530/540/550) or flow cell (SP) when analyzing MRD? 20. Does the kit include positive and negative control for monitoring the amplification/sequencing performance? Yes/No 21. Does the manufacturer provide analysis software for the kit? Yes/No 22. Is the analysis software free of charge? Yes/No 23. Can results be analyzed using a third-party analysis software? If yes, please list. The procured product must comply with HUS IT functional and security requirements. It should operate according to the SFS-EN ISO 15189:2022 standards that guide laboratory activities. Additionally, it must meet other industry guidelines as specified by the given requirements. The response to this request information should include description of fusion test offered. An estimation of the turn-around-time and cost of service should also be included. All information obtained will be held confidential. RESPONSES TO THE REQUEST FOR INFORMATION The response to this request for information should include descriptions to the above questions. Responses are requested to be submitted latest on 15.8.2024 at 12.00 (UTC +2) to kilpailutus.laboratorio@hus.fi

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