Michael Montalto, PhD, of GE Global Research, spoke
on GE's vision of the future at the June 2007 CAP Foundation conference,
"Futurescape of Pathology," in Chicago. Dr. Montalto spoke of how similarities
between pathology and radiology point to a digital future for pathology.
Dr. Montalto is the program leader for GE's molecular imaging and diagnostics
advanced technology program. His remarks follow.
The short story is, if you want to know where anatomic
pathology is going to be in the future, look at radiology. It's not that
much different. Many folks within GE, when they hear about the rumblings
within anatomic pathology, think to themselves: "We've heard that all
before. This is nothing new."
Fundamentally, pathology and radiology are very similar.
They use imaging devices. Their diagnoses are based primarily on anatomy.
A subset of cases is reviewed for molecular information. In the case of
anatomic pathology, we're talking about immunohistochemistry, which is
still the minority of cases in pathology, although we're all anticipating
there to be major growth in that space. Neither of the molecular techniques
is very quantitative. There's much room for improvement for quantitation
in all molecular techniques, whether it be noninvasive imaging or ex vivo.
One of the similarities—and this was a shock
to the folks within GE-is the image size for digitized anatomical pathology
slides. The average radiology exam is maybe 100 megabytes, and the volume
is about 200,000, for maybe 20 terabytes a year within the radiology department,
on average. Digital pathology slides are about one to five gigs in size
at the right kind of resolution for diagnostics. The case volume being
the same, you're looking at 10 to 20 times the amount of data-storage
and data-handling requirements than for radiology. So although both radiology
and pathology have very large image sizes, pathology is by far the heavyweight
in terms of the need for large images.
That is a wake-up call to a company like GE—that
if anatomic pathology were to go digital, we'd have to go way beyond what
we're already doing in radiology. Handling large volumes of images is
key. We knew that in radiology some 20 years ago. We understand that now
in pathology.
Another similarity with radiology is that workflow
can be improved. Many people say of radiology when it was digitized, "Well,
the real reason they went digital is because they got rid of film." But
it was the improvements in workflow in radiology then and that exist today
that drove the adoption of the technology.
So, can that happen in pathology? You bet. There is
an enormous amount of workflow inefficiencies in the current lab. You
have to get glass to a person with a microscope to do reviews, and then
if you want to get consultations, you need to marry the glass with the
patient data and move the glass to another microscope. In cases where
you're shipping the glass to reference labs, all the patient data and
glass have to go and come back. If everything were digital, all that work
would go away, and you would be able to access all of your cases and digital
images at the same time.
Other similarities with radiology: There's simply some
things that you just can't do unless you are digital. In the early days
of radiology, you couldn't convince a radiologist that they were going
to have 64-slice CT and they were going to have to hang all of those images
up on their light box. They would have looked at you like you had two
heads. There was just no way. Now, thinking about putting all those images
on light boxes is ridiculous. Could that happen in anatomic pathology?
Absolutely.
But this is really the bottom line: Can you improve
the quality of care with digital? I don't think anybody would argue that
the quality of care in radiology improved with digital imaging. With the
advent of CT, we know we can get much earlier diagnoses, and we can improve
the quality of care with that. One example—and there are tons of
examples— is a New England Journal of Medicine paper on
a study in which CT screening was done for lung cancer in asymptomatic
patients. Those patients went on to be treated surgically, and there was
a significant difference in outcomes in those who were or would have been
asymptomatic versus those who presented with symptoms.
There is an analogy in anatomic pathology in lung cancer
published in the New England Journal, not too long ago, where
they went way beyond the standard anatomic pathology kinds of measurements.
This was using, at Yale, automated image analysis of a particular biomarker
and showing that nuclear localization of that biomarker can stratify patients
in stage one non-small-cell lung cancer, and certainly those patients
could be treated in a different way. And this is fully automated. So the
quality of care can absolutely be increased if we have digital information.
The reasons why digital path won't happen could have
been "why digital radiology won't happen" 20 years ago. Five years ago,
a lot of this was very much true. A lot of people were not thinking that
digital anatomic pathology could happen, and there were great arguments
as to why it wouldn't happen. I think the tide is turning.
One of these examples is the technology myth, that
the technology simply isn't there to scan the volume of slides needed
to make a diagnosis, or that the quality isn't there, so the perception
is that the throughput isn't fast enough. But we can scan a standard slide
in 30 seconds. This is more than adequate for the majority of pathology
labs in the country. You could probably have two or three machines and
do more. And scan times will eventually get faster.
Another argument against it: We can't browse a slide
fast enough. I think that most browsing now has virtually no latency,
or the latency is sufficiently low enough that you can make a diagnosis.
We know that's true. There have been papers published to that effect.
And another: Data storage is too great and too expensive.
That's no longer true. It's about $1,000 per terabyte for storage, and
that will continue to drop precipitously over time. There is a cost associated
with going digital. If you want to know about it, talk to a radiologist.
They're a very capital-equipment-intensive department. This is not free,
so you have to be getting something out of it.
But how expensive is glass? I would ask you to go back
to your departments and pull out the numbers, if they exist. Somebody
is collating that glass for sign-out, preparing it for shipping, receiving
it, re-preparing it, re-collating it for sign-out again, re-packaging
it, sending it back to the originating institution, finding lost cases-which
nobody likes to talk about, preparing cases for tumor boards, which many
people are doing, waiting for lab results.
Of course, there is lost revenue to competitors who
are digital or are going digital. And there's the opportunity cost of
the throughput that you're not getting because you are doing these other
things. Add that up and ask, "How expensive is it to have glass?"
Another argument: The "no-value" myth. We think there
is probably very real value in both workflow efficiency, reading anytime
anywhere, doing QA and consults, load balancing in cases of multi-institutional
hospitals—which is becoming more prevalent, and retrieving secondary
reads. Just increasing diagnostic accuracy with real-time consultations.
Annotating, localizing, and computer-assisted review is going to be the
future if we go digital. There is real value, beyond monetary value. And
this is not just our perception. We've spent time trying to learn from
you about whether or not this is real.
If adoption is to occur, why, when, and how would it
take place? There has to be an evolution. There are certainly selective
pressures that are going to have to drive adoption of this technology
and the evolution of this market. One of the major pressures is that post-genomic
information has led to molecular diagnostics, some of which will not be
done in the anatomic pathology space, though much of it could be if anatomic
pathology embraces the technology.
You have to look to new ways to improve your throughput
and maintain your costs. The whole computational power and the space of
computation is growing, while the cost of storage is going down. That's
another pressure. That's not only existing for you but also for other
clinical departments. And, of course, a retiring workforce and a general
subspecialty shortage—or a growth of certain subspecialties that
are not always located where you need them.
Those are the pressures. How will it happen? Today,
many anatomic pathologists use a camera on a scope. That's the state-of-the-art
for the most part. Eventually the real gateway is going to be the enabling
of full digital, whole-slide imaging of whole cases. Whether or not the
entire volume of slides happens, or a select number of cases happens first—probably
the latter, we'll see whole-slide imaging potentially for secondary review.
Eventually, as people get more comfortable with the
technology and the technology is more readily available, it will be a
no-brainer to move into primary diagnostics for some of those cases that
you can do some other way, that do not require the comfort of the microscope.
And then eventually this could move into a 100 percent digital environment.
What we see now, in 2007, is the very beginning of
what potentially is the adoption of digital pathology within anatomic
pathology. I don't know if adoption will be fast or slow. I'm hesitant
to say it will be fast. There's a lot that has to be converted within
the anatomic pathology space for it to be fast. But if it's like radiology,
it will be slow but very steady.
When is this going to happen? I'm not sure we're 100
percent there yet with all the technology that's needed for labs to go
digital. We certainly have scanners, local storage to handle those images,
software that can do automated image analysis or semiautomated image analysis,
and imaging browsing. We have not built a total workflow infrastructure
to go along behind all of this—which we would look at, like we did
radiology, to be the foundation of widespread adoption and change.
But there's going to be the front face, which is going
to be the client side that you see, that's going to be specific to anatomic
pathology, or radiology or cardiology, or whatever the new 'ology' happens
to be that moves to adopt digital. So this is all built on one major seamless
network that's sharing data and sharing images. That alone could drive
more of the convergence or collaborative discussion between radiologists
and anatomic pathologists.
The infrastructure changes that have to happen in anatomic
pathology need to be outweighed—because they're not going to be
free—by the workflow efficiency and the enhancement in patient management
that are going to come. This is going to be the so-called tipping point
that would drive anatomic pathology into digital. And you can look to
companies like ours and others that look at this space and say, "When
will this happen?" And I think we have to look to you and say, "You tell
us when you think it will happen. Or you tell the companies that are interested
when you think it will happen." Because it's going to be investments,
and it's going to be your faith in the beginning that you will capture
workflow efficiencies and improve the productivity of your labs, that
will drive the adoption of the technology. I don't think it will be the
companies coming up with the technology. In fact, they won't—business
doesn't work that way. We don't make massive investments in technology
and then hold our breath to see if people will buy it. We need to have
pull for this to happen.
Some things are not like they were and are in radiology.
As I said, no real clinical infrastructure exists in anatomic pathology
for workflow reporting standardization. In terms of the technology, I
think we're almost there. The primary data are not digital. We'll never
go glassless. We may in the very distant future, but I think in the foreseeable
future we're going to have slides to deal with. So the primary data will
come from that.
The images are huge, and there are special challenges
in streaming and storing them. These are not insurmountable problems,
but they are issues that would have to be dealt with. The economics is
a biggie. The space will be capital-intensive. Hospital economics is going
to be a huge barrier. The cost-benefit has not necessarily been established.
I'm not sure how many of you are comfortable sitting
in your CIOs' and CEOs' office and telling them that you need to drop
a couple million dollars on massive infrastructure for anatomic pathology.
That's something that's probably going to have to change for something
like this to happen. If you talk to your radiology colleagues, they'd
probably be happy to walk you through how they do it.
And then there is customer acceptance. I'm probably
sitting in front of a technologically savvy group by virtue of the fact
that you're here. But many other pathologists are not here and probably
don't choose to be here, and are not necessarily too concerned with any
of this. There's a big learning curve that has to happen with anatomic
pathology in order for it to go digital.
So here's the summary: big similarities between radiology
and pathology. We understand this. There are great advantages to going
digital, including workflow efficiencies and improved patient care. Digital
will enable and drive advanced molecular diagnostics within AP. It's just
something that has to happen, like it happened in radiology, and then
you've got all these advanced techniques that were embraced once digital
occurred.
We believe anatomic pathology is poised for a digital
revolution because of the pressures that will drive change. From our perspective,
we think adoption is going to be slow, if it takes place, and dictated
by the benefits of the total end solutions that are connected to digital
and hospital infrastructure.
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