Myeloid neoplasms comprise a biologically and clinically heterogeneous group of clonal disorders characterized by ineffective hematopoiesis, excessive proliferation of hematopoietic stem cells, and defective differentiation. The diagnosis and management of these malignancies, which include Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), and Myeloproliferative Neoplasms (MPN), have significantly evolved with the integration of genomic data. Current World Health Organization (WHO) and European LeukemiaNet (ELN) guidelines emphasize the importance of genetic characterization of key driver genes—such as JAK2, CALR, MPL, FLT3, NPM1, CEBPA, TP53, and SF3B1—for accurate diagnosis, prognostic stratification, and treatment selection.
This comprehensive panel covers relevant regions in genes associated with Myeloid Neoplasms and Acute Lymphoblastic Leukemia (ALL), in accordance with international guidelines.
The assay allows for the simultaneous detection of Single Nucleotide Variants (SNVs), Insertions and Deletions (Indels), Copy Number Variations (CNVs), and structural alterations (translocations/fusions) from a DNA sample. Probe design has been specifically optimized for challenging regions, such as the CEBPA gene and internal tandem duplications (ITDs) in FLT3, to overcome common sequencing limitations and ensure reliable detection of complex variants.
The use of this kit enables precise genetic characterization of patients, supporting medical decision-making and personalized medicine applications.
The NGS on!® Myeloid Panel is a semi-automated kit for Next-Generation Sequencing (NGS) of relevant regions in genes associated with Myeloid Neoplasms (MN) and Acute Lymphoblastic Leukemia (ALL), using genomic DNA extracted from bone marrow or whole blood. The kit includes reagents for the preparation of DNA libraries enriched in target sequences for use on Illumina NGS sequencing platforms.
The intended purpose of the product is the identification of Single Nucleotide Variants (SNVs), Insertions and Deletions (Indels), Copy Number Variations (CNVs), and structural alterations to support the diagnosis, prognostic stratification, and treatment selection for malignancies such as Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), and Myeloproliferative Neoplasms (MPN).
This testing may be performed on patients suspected of having a myeloid malignancy or who require medical treatment based on their genetic characteristics. The results of this test should not be the sole basis for therapeutic decisions and should be used as an aid to diagnosis together with the results of other disease markers.
The intended user of this kit is technical personnel trained and qualified to perform the protocol described in the instructions for use and to interpret its results.
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