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BenchMark XT/LT

Roche BenchMark XT/LT, BenchMark ULTRA Interpretation Guide

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Refer to the corresponding VENTANA MMR RxDx Panel package
inserts for manufacturer contact information.
www.roche.com
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International, Inc. All rights reserved.
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
EC
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
EC
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
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