Oncohematology – Haematology OncoKitDx

NGS kit for the screening for the main molecular biomarkers associated with ALL, AML, CML, MDS, MPN, and other hematologic neoplasms).

Characteristics:

• NGS panel for the study of the the following oncohematological diseases: acute myeloid leukemia (AML), chronic myeloid leukemia (CML), myeloproliferative neoplasms (MPN), acute lymphoid leukemia (ALL), and myelodysplastic syndromes.
• Uses a single DNA sample to detect SNVs, indels, gene fusions, CNVs, and pharmacogenetic variants.
• Bioinformatics analysis with the Data Genomics software and semiautomated generation of reports, including functional and clinical classification of the identified variants.
• STIDs can be included: Integrated sample identification and tracking system.
• Based on high sensitivity RNA-probe technology with UMI barcoding (unique molecular identifiers).
• Coverage (at depth >100x), specificity, sensitivity, repeatability, and reproducibility of this test are greater than 99%. The uniformity of bases covered at >20x is 98.4%.
• Limit of detection: SNVs and Indels: 2%, CNVs: 20% for copy losses and 10% for copy gains
• Compliant with quality specifications by the ISO 13485 and ISO 14001 standards regarding manufacturing materials.
• CE-IVD-marked kit and analysis software.