Roche BenchMark XT/LT Interpretation Guide

Brand: Roche

Model: BenchMark XT/LT

Type: Interpretation Guide

This manual is also suitable for

BenchMark ULTRA

Refer to the corresponding VENTANA MMR RxDx Panel package

inserts for manufacturer contact information.

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VENTANA and the VENTANA logo are trademarks of Roche.

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VENTANA MMR RxDx Panel Quick Reference Guide for EC 1020377EN Rev A

Challenging Cases

VENTANA MMR RxDx Panel Quick Reference Guide for EC 1020377EN Rev A

Non-specific background consistent with

focal DAB trapping in MLH1 Loss Status

should be disregarded for interpretation of

status

Cytoplasmic staining and focal

cytoplasmic speckling in MSH2 Intact

Status should be disregarded for

interpretation of status

MSH6 exhibits focal unequivocal nuclear

staining within tumor cells in the presence

of acceptable internal positive control

cells and therefore is interpreted as

Intact

Absence of

staining in

tumor cells

Focal

staining in

tumor cells

Strong nuclear punctate staining in some

tumor cells. No unequivocal nuclear

staining in tumor in MLH1 Loss Status

PMS2 Loss Status EC with no nuclear

staining in tumor cell exhibits cytoplasmic

speckling which should be disregarded

for interpretation of status

Fixation gradient artifact in tumor cells

and internal positive control cells can

been seen in this MLH1 Intact Status

MSH2 Intact Status in EC exhibiting

heterogeneous nuclear staining intensity

in tumor cells in the presence of

appropriately stained internal controls

Hemosiderin pigment deposition adjacent

to appropriately staining tumor and

internal positive controls should be

disregarded for interpretation of status in

MSH6 Intact Status EC

Non-evaluable MSH2 in EC exhibiting

only membranous staining (blue arrows)

with no appropriately stained internal

controls

MMR Panel: Proficient (mNRC: acceptable mouse negative reagent control, rNRC:

acceptable negative reagent control, MLH1: Intact, PMS2: Intact, MSH2: Intact and MSH6:

Intact)

H&E 20x

mNRC 20x

rNRC 20x

MLH1 20x PMS2 20x

MSH2 20x MSH6 20x

VENTANA MMR RxDx Panel Quick Reference Guide for EC 1020377EN Rev A VENTANA MMR RxDx Panel Quick Reference Guide for EC 1020377EN Rev A

Table 4: VENTANA MMR RxDx Panel Interpretation of Protein Expression

Intact Protein Expression Loss Protein Expression

Unequivocal nuclear staining in viable tumor cells in the

presence of acceptable internal positive controls (e.g.

nuclear staining in lymphocytes, fibroblasts or normal

epithelium in the vicinity of the tumor)

Unequivocal loss of nuclear staining or focal weak

equivocal nuclear staining in the viable tumor cells in the

presence of acceptable internal positive controls. Punctate

nuclear staining is considered negative

Table 5 VENTANA MMR RxDx Panel Interpretation for MMR Status

Proficient Deficient

All four proteins (MLH1, PMS2, MSH2, and MSH6) in the

panel exhibit intact expression

At least one protein (MLH1, PMS2, MSH2, and MSH6) in

the panel exhibit loss of expression

Table 3: Internal Control Staining Criteria

Evaluable Not Evaluable

Presence of unequivocal nuclear staining in normal tissue

elements (e.g. lymphocytes, fibroblasts or normal

epithelium) in the vicinity of the tumor

Absence of unequivocal nuclear staining in normal tissue

elements (e.g. lymphocytes, fibroblasts or normal

epithelium) in the vicinity of the tumor

Table 2: Evaluable and Non-Evaluable Criteria

Clinical Interpretation Staining Pattern Criteria

Evaluable (all must be true)

1. H&E has ≥ 50 viable tumor cells

2. Negative Reagent Control Slide is acceptable

3. Morphology is acceptable

4. Background is acceptable

5. Internal positive controls have unequivocal nuclear

staining

Not Evaluable (if one criteria in this section is true the

slide staining should be repeated or the case rejected,

where applicable)

1. H&E has < 50 viable tumor cells

2. Negative Reagent Control Slide is unacceptable

3. Morphology is unacceptable

4. Background is unacceptable

5. Internal positive controls do not have unequivocal

nuclear staining

6. Interpretation is not possible due to tissue loss, tumor

absence, artifacts and/or edge artifacts

Table 1: Morphology and Background Acceptability Criteria

Criteria Acceptable Unacceptable

Morphology

Cellular elements of interest are

visualized, allowing clinical interpretation

of specific staining

Cellular elements of interest are not

visualized, compromising clinical

interpretation of specific staining

Background

Background does not interfere with

clinical interpretation of specific staining

Background interferes with ability to interpret

specific staining

VENTANA MMR RxDx Panel Staining Characteristics and Algorithm

MMR Panel: Deficient (mNRC: acceptable mouse negative reagent control, rNRC: acceptable negative reagent control, MLH1: Loss,

PMS2: Loss, MSH2: Intact and MSH6: Intact)

H&E 20x mNRC 20x

rNRC 20x

MLH1 20x

PMS2 20x

MSH2 20x

MSH6 20x

MMR Panel: Deficient (mNRC: acceptable mouse negative reagent control, rNRC: acceptable negative reagent control, MLH1: Intact,

PMS2: Intact, MSH2: Intact and MSH6: Loss)

H&E 20x

mNRC 20x

rNRC 20x

MLH1 20x

PMS2 20x MSH2 20x

MSH6 20x

MMR Panel: Deficient (mNRC: acceptable mouse negative reagent control, rNRC: acceptable negative reagent control, MLH1: Intact,

PMS2: Intact, MSH2: Loss and MSH6: Loss)

H&E 20x

mNRC 20x

rNRC 20x

MLH1 20x

PMS2 20x

MSH2 20x

MSH6 20x

Roche BenchMark XT/LT Interpretation Guide

Brand: Roche

Model: BenchMark XT/LT

Type: Interpretation Guide

This manual is also suitable for

BenchMark ULTRA

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Roche BenchMark XT/LT Interpretation Guide

This manual is also suitable for

Roche BenchMark XT/LT Interpretation Guide

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