Poland – Research laboratory services – 107.2026 Usługa wykonania badań biopsji płynnej dla Katedry i Kliniki Transplantacji Szpiku, Onkologii i Hematologii Dziecięcej Uniwersytetu Medycznego im. Piastów Śląskich we Wrocławiu

The subject of the contract is: The service of performing liquid biopsy tests for the Department and Clinic of Bone Marrow Transplantation, Paediatric Oncology and Haematology, Wrocław Medical University named after Piastów Śląskich. 2. Short description of the subject of the contract: The subject of the contract is the service of performing liquid biopsy tests as part of the project „Liquid biopsy and comprehensive molecular analysis of soft tissue sarcomas in children in Poland to improve diagnostics, risk stratification and treatment outcomes”. 3. The service will be provided as part of a project funded by the Medical Research Agency, contract no 2024/ABM/02/00030. 4. The subject of the contract is described in detail in the Detailed Cost Estimate (Annex 2 to SWZ), and in the Contract Template (Annex 3 to SWZ). 5. The service will cover the following activities, hereinafter referred to as Tests: 1) Preparation of the library and sequencing a) whole genome sequencing, determination of methylation class and detection of minimal residual disease (MRD) b) sequencing on dedicated equipment, in a validated process and with quality control of that process; c) inclusion of 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) quantitative assessment of ctDNA; d) assessment of minimal residual disease (MRD) with specified sensitivity thresholds; e) documentation of analytical processes, reference genomes and quality control indicators. 3) Reporting a) structured clinical reports summarising 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 result; c) notification of clinically significant or critical results for the study. 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, in accordance with the General Data Protection Regulation (GDPR) c) specified time of realisation from receipt of sample to preparation of report; d) final delivery of the complete data set at the end of the predefined analysis period. 5) Communication and support a) readiness to provide technical explanations and participation in meetings related to data review and analysis; b) study limitations – ongoing information to the ordering party about factors that may affect the result. 6) Quality and compliance requirements a) use of validated tests suitable for small-volume paediatric samples; b) ensuring full traceability of samples and documentation of analytical and post-analytical stages at every stage; c) ensuring compliance with the GDPR and applicable regulations regarding clinical trials. 7) Delivery of results a) delivery of analytical results and quality control documentation for each sample; b) delivery of structured clinical reports containing at least:  Patient and sample data – date of collection, date of sample receipt by the laboratory  Sample number/identifier and report number  Ordering physician/centre data  Type of material tested and type of tube/anticoagulant  Analysis method – name and version of the test (panel) used  Quantitative assessment of total ctDNA (e.g. ng/ul)  Gene and variant names (according to HGVS nomenclature) along with the reference sequence  Variant assessment according to clinical classification (pathogenic, likely pathogenic, VUS) % VAF (variant allele frequency)  Quantitative determination or information about the absence of the monitored genetic marker  Interpretation of results in the context of RMS biology and known molecular factors, indication of positive/negative result;  Comparison with previous results (in the case of assessment of a subsequent sample from the same patient), including assessment of dynamics/trend (e.g. molecular assessment of disease activity, increase/decrease in VAF over time)  Study limitations – factors that may affect the result  Date of analysis and signature of the responsible person  Qualifications of the responsible person (e.g. specialist in medical laboratory genetics) 8) Transport of samples from the centre in Łódź to the Contractor with assurance of appropriate transport conditions (8 collective transports during the project period in conditions ensuring sample stability) within 2 weeks from the ordering party's request. 2. The deadline for performing the Tests referred to in § 1, paragraph 1, points 1-7, is 21 working days, counted from the day of receipt of the given batch of samples by the Contractor from the centre in Łódź. 3. The maximum number of samples on which the Tests will be performed will be 2400. The actual number of samples will depend on the course of treatment, observation time and the patient's risk group. Settlement will only be made for tests actually performed and documented. 4. The biological material intended for analysis will be peripheral blood (for ctDNA analysis) or isolated tumour DNA/RNA. 5. The maximum number of collective transports of samples from the centre in Łódź (Medical Laboratory of Paediatric Oncology and Haematology Oncolab im. WOŚP, Central Clinical Hospital of the Medical University of Łódź, Building BRAIN A5, ul. Czechosłowacka 4, 92-216 Łódź) to the Contractor's headquarters will be 8.