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Automated processing of fluorescence in-situ hybridization slides for HER2 testing in breast and gastro-esophageal carcinomas.
[esophageal carcinoma]
HER
2
fluorescence
in
-situ
hybridization
(
FISH
)
is
used
in
breast
and
gastro-
esophageal
carcinoma
for
determining
HER
2
gene
amplification
and
patients
'
eligibility
for
HER
2
targeted
therapeutics
.
Traditional
manual
processing
of
the
FISH
slides
is
labor
intensive
because
of
multiple
steps
that
require
hands
on
manipulation
of
the
slides
and
specifically
timed
intervals
between
steps
.
This
highly
manual
processing
also
introduces
inter-run
and
inter-operator
variability
that
may
affect
the
quality
of
the
FISH
result
.
Therefore
,
we
sought
to
incorporate
an
automated
processing
instrument
into
our
FISH
workflow
.
Twenty
-
six
cases
including
breast
(
20
)
and
gastro-
esophageal
(
6
)
cancer
comprising
23
biopsies
and
three
excision
specimens
were
tested
for
HER
2
FISH
(
Pathvysion
,
Abbott
)
using
the
Thermobrite
Elite
(
TBE
)
system
(
Leica
)
.
Up
to
12
slides
can
be
run
simultaneously
.
All
cases
were
previously
tested
by
the
Pathvysion
HER
2
FISH
assay
with
manual
preparation
.
Twenty
cells
were
counted
by
two
observers
for
each
case
;
five
cases
were
tested
on
three
separate
runs
by
different
operators
to
evaluate
the
precision
and
inter-operator
variability
.
There
was
100
%
concordance
in
the
scoring
between
the
manual
and
TBE
methods
as
well
as
among
the
five
cases
that
were
tested
on
three
runs
.
Only
one
case
failed
due
to
poor
probe
hybridization
.
In
total
,
seven
cases
were
positive
for
HER
2
amplification
(
HER
2
:
CEP
17
ratio
>
2
.
2
)
and
the
remaining
19
were
negative
(
HER
2
:
CEP
17
ratio
<
1
.
8
)
utilizing
the
2007
ASCO
/
CAP
scoring
criteria
.
Due
to
the
automated
denaturation
and
hybridization
,
for
each
run
,
there
was
a
reduction
in
labor
of
3
.
5
h
which
could
then
be
dedicated
to
other
lab
functions
.
The
TBE
is
a
walk
away
pre-
and
post-hybridization
system
that
automates
FISH
slide
processing
,
improves
work
flow
and
consistency
and
saves
approximately
3
.
5
h
of
technologist
time
.
The
instrument
has
a
small
footprint
thus
occupying
minimal
counter
space
.
TBE
processed
slides
performed
exceptionally
well
in
comparison
to
the
manual
technique
with
no
disagreement
in
HER
2
amplification
status
.
Diseases
Validation
Diseases presenting
"esophageal carcinoma"
symptom
esophageal adenocarcinoma
esophageal carcinoma
esophageal squamous cell carcinoma
This symptom has already been validated