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Introduction FDA-cleared FISH probes Featured resources

Hematology FISH probes for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS)

AML and MDS are neoplastic hematological disorders that arise from myeloid progenitor cells in the bone marrow. AML is characterized by the clonal expansion of myeloid blasts in the peripheral blood, bone marrow or other tissues, while MDS is characterized by the simultaneous proliferation and apoptosis of hemopoietic cells1.

According to the World Health Organization (WHO), the global incidence for MDS is 3-5 cases per 100,000 (non-age corrected) with approximately 10,000 new cases of MDS diagnosed annually in the USA1. The Surveillance Epidemiology and End Results (SEER) statistics present a similar picture for AML with a USA incidence of 4.3 per 100,000 (non-sex specific)2.

Our range of CytoCell® FDA-cleared Class II IVD FISH probe test kits have been specifically designed to detect common chromosomal rearrangements reported in AML and MDS.

  • Reduce the validation burden for your laboratory: proven safe and effective probes
  • Ensure optimal FISH test performance: FISH probe, DAPI, detailed protocol and analysis guidelines
  • Reduce retest rates: high-intensity signals with excellent contrast 
  • Simplify processing and minimize chance for error: easy-to-use, pre-mixed probes 
Watch the recommended protocol for our CytoCell FDA-cleared hematology FISH probes for AML and MDS

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Discover our FISH probes for AML and MDS

AML1/ETO Translocation, Dual Fusion

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CBFß/MYH11 Translocation, Dual Fusion

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Del(5q) Deletion

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Del(7q) Deletion

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Del(20q) Deletion

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EVI1 (MECOM) Breakapart

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MLL (KMT2A) Breakapart

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P53 (TP53) Deletion

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Featured resources for our CytoCell FDA-cleared probes

Validation Of Signal Pattern Cut Off Levels In Cytocell FDA Cleared AML MDS Probe Kits

Validation of signal pattern cut-off levels in CytoCell FDA-cleared AML/MDS probe kits

Scientific Literature

Recommended FISH protocol for CytoCell AML and MDS FISH probe kits

Prodedure

Reducing your FISH probe validation burden

Scientific Literature

References

  1. Swerdlow, et al (eds). WHO Classification of Tumours of Haematopoietic and Lymphoid Tissue, Lyon, France, 4th edition, IARC,2017.
  2. Noone AM, Howlader N, Krapcho M, Miller D, Brest A, Yu M, Ruhl J, Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA (eds). SEER Cancer Statistics Review, 1975-2015, National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/csr/1975_2015/, based on November 2017 SEER data submission, posted to the SEER web site, April 2018.

Disclaimer

CytoCell®: For In Vitro Diagnostic Use. Rx only. This product has not been validated for use on sample types other than bone marrow specimens, and has not been validated on disease types other than AML or MDS. The CytoCell AML/MDS range of FISH probe test kits are fluorescence in situ hybridization (FISH) tests used to detect common chromosomal rearrangements in fixed bone marrow specimens from patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The tests are indicated for the characterization of patient specimens consistent with World Health Organization guidelines for Classification of Tumours of Haematopoietic and Lymphoid Tissues (Revised 4th Edition) and in conjunction with other clinicopathological criteria. The assay results are to be interpreted by a qualified pathologist or cytogeneticist. The tests are not intended for use as a stand-alone diagnostic, disease screening, or as a companion diagnostic.

Refer to individual test kit Package Insert for the specific intended use and limitations.

The CytoCell AML/MDS range of FISH probe test kits are for sale in the US only. These products have not been licensed in accordance with Canadian law.

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