Tenders Are Invited For Research Laboratory Services - 107.2026 Liquid Biopsy Testing Service For The Depart ... in Poland

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Research Laboratory Services - 107.2026 Liquid Biopsy Testing Service For The Department And Clinic Of Bone Marrow Transplantation, Oncology And Pediatric Hematology Of The Medical University Of Warsaw. Silesian Piasts In Wrocław. 1. The Subject Of The Order Is: Liquid Biopsy Testing Service For The Department And Clinic Of Bone Marrow Transplantation, Oncology And Pediatric Hematology Of The Medical University Of Warsaw. Silesian Piasts In Wrocław. 2. Brief Description Of The Subject Of The Order: The Subject Of The Order Is The Service Of Performing Liquid Biopsy Tests As Part Of The Project Liquid Biopsy And Comprehensive Molecular Tests Of Soft Tissue Sarcomas In Children In Poland In Order To Improve Diagnosis, Risk Stratification And Treatment Results. 3. The Service Will Be Provided As Part Of A Project Financed By The Medical Research Agency, Contract No. 2024/Abm/02/00030. 4. The Subject Of The Order Was Described In Detail In The Detailed Cost Estimate (Appendix No. 2 To The Swz) And In The Contract Template (Appendix No. 3 To The Swz). 5. The Service Will Include The Following Activities, Hereinafter Referred To As Research: 1) Library Preparation And Sequencing A) Whole Genome Sequencing, Determination Of The Methylation Class And Detection Of Residual Cancer Disease (Mrd) B) Sequencing On Dedicated Equipment, In A Validated Process And Quality Control Of This Process; C) Taking Into Account Internal Controls - Positive/Negative Controls. 2) Bioinformatics Analysis A) Preliminary Analysis, Identification Of Bases And Identification Of Variants; B) Detection Of Fusions, Single-Nucleotide Variants (Snvs) And Copy Number Variations (Cnvs); C) Ctdna Quantification; D) Assessment Of Minimal Residual Disease (Mrd) With Specific Sensitivity Thresholds; E) Documentation Of Analytical Processes, Reference Genomes And Quality Control Indicators. 3) Reporting A) Structured Clinical Reports Summarizing Detected Changes, Ctdna Levels, Mrd Status And Quality Control Results; B) Interpretation Of Results In The Context Of Rms Biology And Known Molecular Factors, Indication Of Positive/Negative Results; (C) Notification Of Clinically Important Or Study-Critical Results. 4) Data Delivery A) Provision Of All Raw And Processed Data, Including Fastq, Bam/Cram, Vcf Files And Variant Tables With Annotations In Pdf And Csv Formats B) Secure Data Transfer, Compliant With Gdpr C) Specified Implementation Time From Receiving The Sample To Preparing The Report; D) Final Delivery Of The Complete Data Set At The End Of The Predetermined Analysis Period. 5) Communication And Support A) Willingness To Provide Technical Explanations And Participate In Data Review And Analysis Meetings; B) Limitations Of The Study - Keeping The Ordering Party Informed About Factors That May Influence The Result. 6) Quality And Compliance Requirements (A) Use Of Validated Tests Suitable For Small Volume Pediatric Samples; B) Ensuring Full Traceability Of Samples And Documentation Of Analytical And Post-Analytical Stages At Every Stage; C) Ensuring Compliance With Gdpr And Applicable Regulations Regarding Clinical Trials. 7) Delivery Of Results A) Providing Analytical Results And Quality Control Documentation For Each Sample; B)

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