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FDA-cleared IVD

Acute myeloid leukemia (AML) and myelodysplastic syndromes (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.

Introducing Cytocell Aquarius® FDA-cleared Class II IVD FISH probe test kits

https://youtu.be/VNdmbO08MW4

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

Probe

 AML

MDS

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AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion FISH Probe Kit

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CBFβ (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit

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Del(5q) Deletion FISH Probe Kit

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Del(7q) Deletion FISH Probe Kit

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Del(20q) Deletion FISH Probe Kit

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EVI1 (MECOM) Breakapart FISH Probe Kit

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MLL (KMT2A) Breakapart FISH Probe Kit

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P53 (TP53) Deletion FISH Probe Kit

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FDA-cleared IVD AML and MDS FISH probe kits provide:

  • Proven safe and effective probes—reduce the validation burden for your laboratory

  • FISH probe, DAPI, detailed protocol and analysis guidelines—ensure optimal FISH test performance

  • High-intensity signals with excellent contrast—reduce retest rates

  • Easy-to-use, pre-mixed probes—simplify processing and minimize chance for error

All backed by expert support from our technical specialists enabling you to focus on delivering high quality, rapid results.

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

The Cytocell Aquarius 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

For In Vitro Diagnostic Use. Rx only.

Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representatives for availability.

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