CAT #: 14120019
FLT3 ITD MRD Assay
This Research Use Only assay targets the juxtamembrane (JM) region of the FLT3 gene to identify ITD mutations using the Illumina® MiSeqTM platform.
Summary and Explanation of the Test
Mutations in the fms-like tyrosine kinase 3 (FLT3) gene are the most prevalent mutations found in acute myeloid leukemia (AML) and are characterized by an aggressive phenotype with a high prevalence of relapse.1 Internal tandem duplications (ITD) within the juxtamembrane domain are the most common mutations of the FLT3 gene and occur in about 25% of newly diagnosed AML patients.2,3 The development of a sensitive and specific assay to estimate the variant read frequency (VRF) of FLT3 ITD MRD represents a significant advancement for AML research.
Invivoscribe’s FLT3 ITD MRD Assay is an NGS-based, targeted, deep-sequencing assay that detects and monitors DNA sequences specific to identified mutations from the primary sample identified at diagnosis at an allelic sensitivity level of 5×10-5. This assay enables clinicians to identify subjects with no overt evidence of disease that may benefit from continuation or modification of treatment.4
MRD detection by Next-Generation Sequencing has demonstrated utility in predicting clinical outcomes and in generating clinically actionable results, allowing early intervention, confirmation of disease status prior to transplant, and increased confidence in remission status.
Principles of the Procedure
Polymerase chain reaction (PCR) amplification for the detection of the FLT3 ITD mutation is used on DNA isolated from the sample. Barcoded primers amplify the sequences of interest. The ITD wild type produces a fragment that is 327 bp, while the presence of an insertion produces a fragment that is ≥ 330 bp. This assay has an analytical sensitivity of 5 x 10-5 mutant alleles per total alleles. Note, this analytical sensitivity was validated for an ITD size of 30 bp. While the maximum ITD size detectable by this assay is 252 bp, the detectable size and sensitivity vary depending on an ITD’s insertion location and sequence.
This RUO assay tests genomic DNA isolated from peripheral blood or bone marrow. The minimum input quantity is 700 ng of high quality DNA.
1. The Cancer Genome Atlas Research Network. (2013) New England Journal of Medicine. 368: 2059–2074.
2. Konig, H et al. (2015) Expert Opinions in Therapeutic Targets. 19:37-54.
3. Daver N et al. Leukemia. (2019) 33:299-312.
4. Levis, MJ et al. (2018) Blood Advances. 2: 825-831.
This product is for Research Use Only; not for use in diagnostic procedures.
Warranty and Liability
Invivoscribe, Inc. (Invivoscribe®) is committed to providing the highest quality products. Invivoscribe® warrants that the products meet or exceed the performance standards described in the Instructions For Use, as to products with such an insert. If a product is covered by product specifications and does not perform as specified, our policy is to replace the product or credit the full purchase price. No other warranties of any kind, expressed or implied, are provided by Invivoscribe®. Invivoscribe® liability shall not exceed the purchase price of the product. Invivoscribe® shall have no liability for direct, indirect, consequential or incidental damages arising from the use, results of use, or inability to use its products; product efficacy under purchaser controlled conditions in purchaser’s laboratory must be established and continually monitored through purchaser defined and controlled processes including but not limited to testing of positive, negative, and blank controls every time a sample is tested. Ordering, acceptance, and use of product constitutes purchaser acceptance of sole responsibility for assuring product efficacy and purchaser agreement to the limitation of liability set forth in this paragraph.
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