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The National Genomic Test Directories specify which genomic tests are commissioned by the NHS in England, to be delivered by Genomic Laboratory Hubs.

Clinical Indication ID & Name

M94

Chronic Lymphocytic Leukaemia

Test Group

Haematology

Specialties

Test code

M94.1

Test name

Multi-target NGS panel - small variant (TP53,BTK, PLCG2, BCL2)

Target genes

TP53, BTK, PLCG2, BCL2

Test scope

Small variant detection

Test method/ technology

Panel

Optimal Family Structure

n/a

Eligibility Criteria

Patient with CLL about to undergo treatment (NB can be any line of treatment)
Also in cases previously classified as B-PLL, now considered to be CLL/SLL which has undergone prolymphocytic progression, are also eligible for testing under this clinical indication.

Test code

M94.2

Test name

Multi-target NGS panel - copy number variant (TP53,ATM, DLEU2/7, RB1, trisomy 12)

Target genes

TP53, ATM, DLEU2/7, RB1, trisomy 12

Test scope

Copy number variant detection to exon level resolution

Test method/ technology

Panel/Array

Optimal Family Structure

n/a

Eligibility Criteria

Patient with CLL about to undergo treatment (NB can be any line of treatment)
Also in cases previously classified as B-PLL, now considered to be CLL/SLL which has undergone prolymphocytic progression, are also eligible for testing under this clinical indication.

Test code

M94.4

Test name

del(17p) TP53 copy number FISH

Target genes

TP53

Test scope

Copy number variant detection to genomewide resolution

Test method/ technology

FISH

Optimal Family Structure

n/a

Eligibility Criteria

Patient with CLL about to undergo treatment (NB can be any line of treatment)
Also in cases previously classified as B-PLL, now considered to be CLL/SLL which has undergone prolymphocytic progression, are also eligible for testing under this clinical indication.

Test code

M94.5

Test name

Ig gene (heavy & light chain) rearrangement & hypermutation detection multiplex seq

Target genes

IGH, IGK, IGL

Test scope

Complex variant detection

Test method/ technology

Complex targeted mutation testing

Optimal Family Structure

n/a

Eligibility Criteria

Patient with CLL about to undergo treatment (NB can be any line of treatment)

Test code

M94.6

Test name

Ig gene (heavy & light chain) rearrangement & hypermutation detection NGS

Target genes

IGH, IGK, IGL

Test scope

Complex variant detection

Test method/ technology

Panel

Optimal Family Structure

n/a

Eligibility Criteria

Patient with CLL about to undergo treatment (NB can be any line of treatment)

Test code

M94.7

Test name

TP53 seq

Target genes

TP53

Test scope

Small variant detection

Test method/ technology

Single gene sequencing

Optimal Family Structure

n/a

Eligibility Criteria

Patient with CLL about to undergo treatment (NB can be any line of treatment).
Also in cases previously classified as B-PLL, now considered to be CLL/SLL which has undergone prolymphocytic progression, are also eligible for testing under this clinical indication.

Test code

M94.8

Test name

11q copy number FISH

Target genes

ATM

Test scope

Copy number variant detection to genomewide resolution

Test method/ technology

FISH

Optimal Family Structure

n/a

Eligibility Criteria

Patient with CLL about to undergo treatment (NB can be any line of treatment)

Test code

M94.9

Test name

13q copy number FISH

Target genes

RB1

Test scope

Copy number variant detection to genomewide resolution

Test method/ technology

FISH

Optimal Family Structure

n/a

Eligibility Criteria

Patient with CLL about to undergo treatment (NB can be any line of treatment)

Test code

M94.10

Test name

chromosome 12 copy number FISH

Target genes

chr12

Test scope

Copy number variant detection to genomewide resolution

Test method/ technology

FISH

Optimal Family Structure

n/a

Eligibility Criteria

Patient with CLL about to undergo treatment (NB can be any line of treatment)

Commissioning group

n/a

Overlapping idications

n/a

Address for samples/request forms

South East HMDS
c/o Central Specimen Reception
Synnovis Analytics
Ground Floor Bessemer Wing
King’s College Hospital
Denmark Hill, London SE5 9RS

Contact with queries

kch-tr.sehmdsreception@nhs.net

Supporting documents

n/a

Education resources

n/a

Turn around times

All our turnaround times are listed on our specific turn around page https://southeastgenomics.nhs.uk/professionals/service-turn-around-times/

Request form download

Cancer Haematology Order Form Haematology Sample Log Form Record of Discussion Form

Consent record

See consent guidance in test request form

Sample requirements

Samples may be rejected for the following reasons: 1.Samples and request form do not show at least three identical patient identifiers 2.The sample is in the incorrect collection media 3.The request form is not sufficiently completed 4.The sample is not of sufficient volume 5.The sample is too old