IntelliGEN® Myeloid
Also known as: cobas® EZH2 Mutation Test
Use
The intended use of this multi-gene genomic panel is in patients with myeloproliferative neoplasms (MPN), myelodysplastic syndrome (MDS), and acute myelogenous leukemia (AML). These disorders are clonal disorders of hematopoietic stem cells and share clinicopathologic features and underlying molecular drivers. Emerging evidence supports the clinical value of simultaneous detection of somatic mutations in multiple genes as markers for neoplastic clonal populations to guide 1) diagnosis, 2) prognostic risk assessment, and 3) therapeutic options.
Special Instructions
Please provide a clinical indication or related ICD‑10 code on the requisition. Test will be delayed if the clinical indication is not received. Please direct any questions regarding this test to customer service at 800‑345‑4363.
Limitations
The sensitivity of this assay is 5 to 10% variant allele fraction for single nucleotide variants (SNV) and insertion/deletions (InDels). Insertions up to 126 bp and deletions up to 52 bp have been detected in clinical specimens. Mutations outside the targeted regions and gene rearrangements will not be detected. Variants are categorized into Tiers based on their clinical impact, following AMP/ASCO/CAP consensus recommendations with four levels (A‑D) based on clinical significance, and results should be interpreted in conjunction with clinical and other laboratory findings.
Methodology
NGS (Targeted)
Biomarkers
Result Turnaround Time
10-14 days
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
3‑5 mL
Minimum Volume
3 mL
Container
Lavender‑top (EDTA) tube, green‑top (sodium heparin) tube, tan‑top (K2‑EDTA) tube or pink‑top (K2‑EDTA) tube
Storage Instructions
Refrigerate.
Causes for Rejection
Specimen does not meet criteria for sample type, container, minimum volume, collection and storage; frozen whole blood or marrow; leaking tube; clotted blood or marrow; grossly hemolyzed specimen or otherwise visibly degraded; contaminated specimen; contains suspicious foreign material
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