Product Availability Key

  • Mexico and Canada flagMexico and Canada
  •  Outside North America flag Outside North America
  •  US flag US
  • Mexico and Canada flag
  •  Outside North America flag
  •  US flag

CAT #: 14120019


Assay Use

This Research Use Only assay targets the juxtamembrane (JM) region of the FLT3 gene to identify ITD mutations using the Illumina® MiSeqTM platform.

Product Details

  • 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.1 About 75% of FLT3-ITDmut+ AML demonstrate an ITD mutation at relapse.2 The presence of a FLT3-ITD mutation in relapsed/refractory disease is associated with shorter duration of remission, increased risk of relapse,3 disease progression, a worse prognosis4 and decreased overall survival following standard-of-care therapy3. Furthermore, in a study evaluating MRD prior to alloHCT, detection of mutated FLT3-ITD and/or NPM1 at an allele fraction ≥0.01% was associated with relapse and worse survival.5  

    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 with an allelic sensitivity level of 5×10-5.  This assay identifies and reports  ITD insertions in subjects with no overt evidence of disease. In addition, the FLT3 ITD MRD Assay can be multiplexed with the NPM1 MRD Assay to improve throughput and reduce cost.

    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 FLT3 ITD mutations is used on DNA isolated from the specimen. Barcoded primers target the area around the juxtamembrane (JM) region of the FLT3 gene to amplify the sequences of interest. The PCR products are then purified and prepared for sequencing on the MiSeqTM  instrument.  Sequencing results are interpreted by the FLT3 MRD Software, generating a TSV output.

    This assay detects ITDs from 9 base pairs up to a length of 252 base pairs and insertions from 3 base pairs to less than the maximum ITD size with an analytical sensitivity of 5 x 10-5* mutant alleles per total alleles. The detectable size and sensitivity vary depending on the insertion location and sequence. *Note, this analytical sensitivity was validated for an ITD size of 30 bp.

  • Specimen Requirements

    This RUO assay tests genomic DNA isolated from peripheral blood or bone marrow. Assay sensitivity is dependent on DNA input and read count. Minimum input quantity is 700 ng of high quality DNA.

    Baseline sample is not required for MRD testing.


  1. The Cancer Genome Atlas Research Network. (2013) N Engl J Med. 368: 2059–2074.
  2. Kronke et al. (2013). Blood. 122 (1): 100–108.
  3. Daver N et al. (2019) Leukemia. 33:299-312.
  4. Warren et al. (2012). Modern Pathology. 25, 1405-1412.
  5. Dillon et al. (2023). JAMA. 329(9):745-755.


This product is for Research Use Only; not for use in diagnostic procedures.

Legal Notice

Now Available

Our New Document Search Feature

Need Help Placing an Online Order?

Contact our Customer Service Team

Now Available

Our New Document Search Feature

Need Help Placing an Online Order?

Contact our Customer Service Team