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Myeloid-NDC

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Our first 2024 product, the Myeloid-NDC assay is intended for the integrated and qualitative detection of chromosomal translocations, copy number variants (CNV) and sequence variants from suspected or confirmed cases of myeloid malignancies. The Myeloid-NDC assay has been validated for use with high molecular weight (HMW) genomic DNA (gDNA).

The Myeloid-NDC assay has been designed as an integrated tool covering most genomic alterations recommended for the analysis of acute myeloid leukaemias (AML), myelodysplastic syndromes (MDS) and myeloproliferative neoplasms (MPN). The Myeloid-NDC assay provides a simple solution to allow laboratories to produce integrated reports according to the newest guidelines and recommendations, using just a single DNA sample (with no need for an RNA sample).

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Composition of Myeloid-NDC assay

The Myeloid-NDC assay contains most guidelines-recommended genomic regions covering chromosomal translocations and fusion genes, copy number variants (CNV) and sequence variants from suspected or confirmed cases of AML, MDS and MPN.

List of genes with select regions for mutation assessment on Myeloid-NDC

Additional Regions & Additional Chromosome Regions Assessed

Performance specifications of the Myeloid-NDC

Expected Metrics:

The table below shows the approximate expected metrics of the Myeloid-NDC assay based on 16 samples per hybridisation reaction (plus controls) and run on a NextSeq500/550 (Mid- Output 150 cycles cartridge) at 2 x 75bp. These can vary depending on DNA quality and quantity, technical factors in each laboratory, differences in equipment, performance of libraries, etc.

 

ParameterExpected value
Library yield (ng)3,000 (range: 1,000-6,000)
Library average Library average
fragment size (bp)
330 (range: 275-450)
Average on/near
target bases (%)
80% (range: 70%-85%)
Duplicate reads (%)25% (range: 15%-35%)
Mean target unique
coverage (reads)
1,000x (range: 500x-1,500x)

Observed Analytical Performance:

The following table represents the observed analytical performance for the Myeloid-NDC assay:

 

SensitivitySpecificityLimit of Detection
SV>95%>99%5%
VAR>99%>99%4%
CNV*>95%>97%40% (tumour cells)

SV: structural variants, VAR: sequence variants, CNV: copy number variants. *The threshold baseline fold-change for deletions detected by Myeloid-NDC is 0.8 and 1.3 for losses and gains, and 0.7 and 2.0 for deletions and amplifications, respectively.

Myeloid-NDC Copy number variant (CNV) analysis

Example of a good quality CNV profile from a sample with normal male karyotype

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