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Myeloid Backdrop

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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

Gene NameRegion Covered
ABL1All coding
ANKRD26Exon 1
ARAFExons 4, 7, 10, 15
ASXL1All coding
ASXL2Exons 9-13
ATG2BExon 1
ATRXAll coding
BCORAll coding
BCORL1All coding
BRAFExons 11, 12, 15
CALRExons 8, 9
CBLExons 4-9
CBLBExons 8-17
CCND2All coding
CCND3Exon 5
CDKN1BAll coding
CDKN2AAll coding
CDKN2BAll coding
CDY1BExon 1 (partial)
CEBPAAll coding
CHEK2All coding
CREBBPAll coding
CSF3RExons 14-17
CSNK1A1All coding
CTCFExons 3 (partial), 4-8
CTNNA1Exons 6-17
CUX1All coding
DDX41All coding
DHX15Exons 2-5
DIS3All coding
DNMT3AExons 4-23
EP300All coding
ERBB3Exons 3-8, 15, 22-24
ETNK1Exon 3
ETV6All coding
EZH2All coding
FBXW7All coding
FLT3Exons 11, 13-15, 16, 20
GATA1All coding
GATA2All coding
GATA3Exon 6
GNASAll coding
GNB1Exons 5-6
HRASExons 2-4
IDH1Exon 4
IDH2Exon 4
IKZF1All coding
JAK2Exons 8-19
JAK3Exons 11-22
KDM6AAll coding
KDRExons 11, 12, 23
KITExons 8-11, 13, 17-18
KMT2AExons 6-27
KMT2CAll coding
KMT2EAll coding
KRASExons 2-4
MAP2K1Exons 2-3
MAP3K1Exons 14-20
MAPK1Exons 4, 7
MBD4All coding
MGAExons 3, 9, 18
MPLExons 10-12
MST1Exons 7-14
MYCExon 2
NF1All coding
NFE2All coding
SRP72Exons 6-10
SRSF2Exon 1
STAG2All coding
STAT5BExons 14-16
TERCExon 1
TERTAll coding and promoter
TET2All coding
NPM1Exons 10-11
NRASExons 2-4
NSD1All coding
NUP98All coding
PHF6All coding
PIK3CAExons 10, 21
PIK3CDExons 9-11
PMLExon 6
PPM1DExon 6
PTPN11Exons 3, 8, 12-13
RAD21All coding
RB1All coding
RIT1Exon 5
RUNX1Exons 4-9
RUNX1T1All coding
SAMD9Exon 3
SAMD9LExon 5
SETBP1Exon 4
SF3B1Exons 13-18
SH2B3Exons 2 (partial), 3-8
SMC1AAll coding
SMC3All coding
TP53Exons 2-10
U2AF1Exon 2
UBA1Exon 3
WT1All coding
ZBTB7AExon 2
ZRSR2All coding

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


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