EuroClonality-NDC

Euroclonality backdrop

Why settle for less
when you can have it all?

Our first product, the EuroClonality-NDC assay allows you to detect immunoglobulin (IG) and T-cell receptor (TR) rearrangements and translocations, as well as mutations and copy number alterations in clinically relevant genes for most lymphoproliferative disorders.

EuroClonality-NDC has been designed and developed by the EuroClonality-NGS working group (an independent subdivision of EuroClonality) and validated in a multi-centre international study involving expert clinical and academic laboratories across Europe.

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What our customers say

“We incorporated the EuroClonality-NDC assay for routine IG and TCR marker identification for MRD studies about a year ago. We have analysed more than 1000 samples so far and we are very happy with the results.” Prof. Monika Brüggemann from Kiel University, Germany

“The EuroClonality-NDC assay is a really convenient and useful tool for lymphoma testing. In our institution, we started with a pilot research project and after few months we incorporated it into routine use.” Dr Sarasquete and Dr Alcoceba, Salamanca University Hospital, Spain

“The EuroClonality-NDC assay offers and integrated and comprehensive assessment of the most important genomic aberrations required for routine diagnostic haematopathology practice, streamlining the request and reporting process. We can now simultaneously detect mutations, structural aberrations and assess clonality in FFPE specimens, achieving excellent correlation with legacy molecular tests. Since we incorporated the assay into our workflow, EuroClonality-NDC results have facilitated a more robust diagnosis in many cases, and in some cases have enabled diagnoses and distinctions that we were previously unable to render. This includes, for example, identifying emerging lymphoproliferations such as BCL3 translocated lymphomas, and distinguishing between plasmablastic myeloma and plasmablastic lymphoma. The failure rate of the assay is low and regularly obtain viable results on decalcified bone marrow specimens. Overall, we are delighted with the performance of the EuroClonality–NDC assay and thoroughly recommend it to other haematopathologists” Dr Matthew Pugh, Consultant Haematopathologist, Birmingham and Wales, UK

Composition of EuroClonality-NDC assay

The EuroClonality-NDC assay contains a series of genomic regions covering all the IG (including IGH switch regions) and TR genes, intronic regions of some commonly translocated genes, coding regions of clinically-relevant genes and specific regions for copy number variation (CNV) analysis.

List of genes with full coding regions mutation assessment on EuroClonality-NDC

ARID1A	EP300	MAP3K14	SAMHD1
ATM	ERG	MAPK1	SOCS1
B2M	FAT1	MYC	TCF3
BCL2	H1-5	PAX5	TENT5C
BTG1	H1-2	PHF6	TET2
BTK	H1-3	POT1	TNFAIP3
CDKN2A	H1-4	PTEN	TP53
CDKN2B	ID3	PTPRD	TRAF2
CDKN2C	KLF2	RHOA	TRAF3
CKS1B	KMT2D	RUNX1	WT1

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

Gene Name	Region Covered
ABL1	Exons 4-9
ASXL1	Hotspot in last exon
BIRC3	Exons 8 and 9
BRAF	Exons 11 and 15
CARD11	Exons 2-16
CCND1	Exon 1
CCND3	Exon 5
CD79A	Exons 4 & 5
CD79B	Exons 4-6
CREBBP	Exons 2-30
CXCR4	Hotspot in exon 2
DIS3	Exons 1-3 and 9-18
DNMT3A	Exons 8-23
EGR2	Hotspot in exon 2
EZH2	Exons 15-17
FBXW7	Exons 1-12
FOXO1	Exon 1
IDH1	Exon 4
IDH2	Exons 4 and 7
IKZF1	Exons 2-7
IL7R	Exon 6
IRF4	Exons 2-3
JAK1	Exons 12-15
JAK2	Exons 12-15
JAK3	Exons 11-24
KIT	Exons 9, 11, 13, 17 and 18
KRAS	Exons 2, 3 & 4
MAP2K1	Exons 1-8
MEF2B	Exons 2-4
MYD88	Exon 3-5
NFKBIE	Exon 1
NOTCH1	Exons 26, 27 & 34
NOTCH2	Exon 34
NRAS	Exons 2-4
NT5C2	Exons 9-15
PIK3CA	Exons 2, 5 10 & 21
PLCG1	Exons 1, 11, 15-17, 19 and 29
PLCG2	Exons 19, 20 & 24
SF3B1	Exons 12-17
STAT3	Exons 10-16 and 20-21
STAT5B	Exons 13-19
STAT6	Exons 5, 9, 11, 12 and 14
XPO1	Exons 15-16

Additional Regions & Additional Chromosome Regions Assessed

List of additional regions assessed for translocations on EuroClonality-NDC

List of additional chromosome regions assessed for copy number variation on EuroClonality-NDC

Performance of the EuroClonality-NDC assay

The expected metrics for library preparation and hybridisation performance ensure sufficient coverage of all targets to obtain robust and reliable results.

Analytical sensitivity varies according to the type of alterations, from >95% for CNV up to >99% for sequence variants at >4% VAF. Analytical specificity also varies from >97% for CNV and IG/TR rearrangements up to >99% for sequence variants at >4% VAF.

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Expected metrics & Analytical Performance