Greg Lucier: Well, first of all, I want to compliment Eric
and Rick for a tour de force in terms of a review of the landscape of what's going on
in genomics.
And as I stand here, I want to make sure I'm complementing what they say and not being
repetitive, so I have to be a little quick in terms of what to do.
It reminds me of saying that when I first went skydiving the instructor said, "Listen,
if both parachutes don't open, don't worry, you have the rest of your life to figure something
out."
So --
[laughter]
-- in a matter of a couple of seconds here, I'll try to make sure that I can say something
that I think adds to the body of discussion.
Let me just touch on a few points that I think both of them made quite well, but I can give
you at least an insider's baseball view of what it all means.
As both Eric and Rick referenced, there has been this very fast rush to miniaturization,
to faster speeds of sequencing, and to ever lower costs of getting the sequence itself.
And I think both of them did a nice job of giving this metaphor of the computer industry
moving from mainframes to midframes, where we were probably three or four years ago,
to now where it's down in that genome exhibit you're seeing basically on a desktop.
And this industry is tracking perfectly to what we saw in the computing industry.
I think what also, though, should be -- maybe I could give you some sense of, is what's
going on from an industrial perspective to do that.
And the pace of innovation, as has been said, is four times faster than the venerable Moore's
Law.
And what that then means is really interesting changes inside an organization, a corporation,
to deliver that rate of innovation.
And so our Ion Torrent team is now comprised of about 500 scientists, they work 24 by 7,
they have set up their schedules to do that.
They have huddles that are happening every eight hours in terms of reviewing technical
progress, and so the point I would simply say is that in our organization, and I'm sure
in our competitors' organizations, the pace of innovation, the method of organizational
approach is a real advantage, it's here in the United States, and I think it's one of
the great byproducts that's come out of this Human Genome Project and ultimately this race
towards creating that iSeq product that Rick challenges us to get to here in the next couple
of years.
You know, having said that, just to jump down, we believe that there has been an important
decision made at least by our organization in this technology race.
And there are three broad approaches to how you can do this bridge between the chemical
world, which is your genome, and the digital world, which is the information of what it
means.
And the three basic approaches are to use light, or essentially a camera or a laser,
to take a picture of it.
The second approach would be to thread it through a hole, if you will, and then read
it as it comes through, a nanopore approach.
Or the third approach is to use transistors or a semiconductor to basically be able to
read a change in pH, or -- that's what we do here -- onto a transistor, and instantaneously
then determine what it was: A, T,C, or G. And we chose that approach.
Others have chosen different approaches.
They all have their merits, they all have some consequences.
But they all are driving towards, is that point of miniaturization, faster speeds, lower
costs.
We're trying to take advantage of $1 trillion that goes into the semiconductor industry
and is making at a similar breakneck pace.
The other point I'd say in terms of industry ramifications is now the advent of an enormous
amount of venture capital going into the IT part of the genomics race.
There are probably no fewer than 40 companies that have been funded by various venture capital
entities to develop companies that will take this amount of information and then turn it
into something relevant.
And it's a very vibrant part of the industry that we see today, it's very exciting.
And it's very uncertain how it all -- in terms of will be structured.
Who will do these information systems?
Who will buy these information systems?
And so -- and it's a truly entrepreneurial phase that we find ourselves in in this genomic
race going on.
What I'd like to do is just jump down to a few points that maybe I can talk to in terms
of other aspects of the environment we're in right now of this genomics era.
And I'll just talk to a few of them around policy, funding, and then the practice of
medicine.
As I was saying the other day, once you can -- once something is possible, then you have
to do it.
And that's really the discussion going on now, of how do you take this incredible amount
of science, of research, of technology, and move it into the clinic to do good benefit
for patients.
And in order for that to happen, you have to create the right commercial environment
to be in place.
We need the right regulatory framework, we need the right reimbursement framework, because
we're talking health care, and many of those things aren't quite in place yet today in
the United States.
They're actually in place in other countries in a far better way.
But here in the United States, we've got some work to do to further clarify, further refine,
the regulatory environment to allow this commercial diagnostics, this commercial practice of medicine
to take place.
Specifically in the area of reimbursement, the basic regulatory scheme for reimbursement
in genomics is actually being leveraged off what was done in an earlier era of clinical
chemistry; it's completely inappropriate to support the level of work that would get done
in genomics.
And so right now, quite frankly, the economics aren't so great for running a human genome
at mass scale at a hospital near you.
And so that has to get rectified.
The other thing that's also in contention right now is just the regulatory framework
of what can be allowed.
And without overcomplicating it, there are two ways that diagnostic tests get done in
the United States.
One is directly overseen by the FDA, and the other is done by Medicare or CMS.
And the question is where will these genomic tests ultimately get practiced?
Will it be in this FDA-regulated environment, or in this Medicare/CMS regulatory environment?
They are very different, and, quite frankly, there is contention between the two bodies
that creates complication and uncertainty.
And, as you know, whenever you have uncertainty it's very hard, then, to launch a business
with more, you know, success.
The one point I would say about how these diagnostic tests will happen in the future
is something that Eric pointed out.
Up until now, virtually all the gene tests that were done have been monogenic, single
genes that you're looking for, simple test, and it's a fairly simple approach in terms
of getting some reimbursement for that.
All the things that both Eric and then Rick talked about are being multigenic are complex,
require lots of analysis, using very sophisticated IT tools, and are going to be more like how
a radiologist interprets a image.
And this is going to be much more in the mainstream of medicine, and our current regulatory approach,
reimbursement approach, doesn't support that.
And so these tests, and then how they have to be treated, are fundamentally different
as I say, than what was in the past.
Last point I would simply say on policy is just something Rick and Eric both also pointed
out, it is unfortunate that we find ourselves in this golden era of understanding of what
it means and what it can do in terms of outcomes for patients, and yet it comes at the very
same time that we're cutting back funding for the research in this space.
Again, I would point out, other countries are doing just the opposite.
So -- and, you know, the one thing I would like to share with you is actually an image.
This is the breast cancer genome.
It's fitting that we're looking at that given the ruling from the Supreme Court today on
the Myriad gene patents that center around the BRCA gene, relative and important to breast
cancer.
But the question I would give to you is, "What will the doctor of the future look at to determine
what problem you have genetically, and what can be done then therapeutically to solve
your problem?"
And we spend a lot of time about that in industry thinking about, "Somebody has to look at this
information, somebody has to then be able to quickly ascertain what's going on, and
then render a diagnosis."
And again, this is a fundamentally different workflow in medicine than has been done before,
and, you know, what I've often said to people, "This is an image, this is just like an MRI
or a CAT scan, and there is a medical specialty called radiology in that field that's been
trained up to look at those images."
That same specialty does not exist in the practice of medicine.
And so we've got some fundamental things to figure out in terms of what is the focal point
of this new genomic era in medicine because who's going to do the work, and who's going
to ultimately sit down with the patient and tell them what's going on?
You know, I don't know if this is quite true, you go do the work to do the final analysis,
but I've heard that in medical school here circa 2013, you're only getting two to three
works of training in genomics at the average medical school program today.
That's got to fundamentally change.
It probably has to be flipped on its ear.
So big changes have to come and, you know, in order to really support what we think is
an incredible era ahead of us.
What I'd just like to finish up with then, to be brief, is talking about what's next.
Our organization is on a fast pace to continue to innovate around this whole idea of reading
DNA.
Everything we've spoken to you about is about reading DNA.
And yet with its approaching now economics that make mass sequencing possible on many
fronts, it opens up a whole new chapter in terms of writing DNA, or creating synthetic
genes or genomes.
And this combination of reading DNA and writing DNA, I think, is going to be a massive economic
stimulus in the 21st century.
If the 20th century was about the physical sciences, creating of semiconductors and moving
electrons around, the 21st century is all about the understanding of life, and harnessing
the ability to read and write DNA.
And you don't have to go very far to think about the possibilities.
The chemical industry is based off of breaking down organic matter, ultimately, into chemicals,
into plastics and the like.
There is massive move underway in terms of research to create biological pathways in
microbes to have the same effect.
And when we have this ability to harness the power to read and write DNA, you can transform
big portions of the chemical industry, as an example.
That will change both the materials industry, change the energy industry, and, you know,
the possibilities are endless.
And so we're extremely excited not only about the innovation going on in reading DNA, but
in the case of our organization, we have a very large R&D effort geared up to figure
out how to write DNA in a very cost-effective way to make these transformations in different
industries possible, and to bring about this life sciences century here in the 21st century.
Thanks very much.
[applause]
Larry Thompson: So I just want you to stay for a second.
So what I was going to do was have our three people talking about the use of technology
to answer questions together, but why don't we see if, does anybody have a burning question
for Mr. Lucier, and if not, we will skip to the second panel because we are seeming to
run a bit behind.
Burning question from the reporters, anybody?
I think you're off the hook, sir.
What I'd like to do is ask Susan Dillon to come up, she's from Johnson & Johnson, and
can -- is an immunologist working in this area and using these technologies to figure
out how to get through the era of actual clinical care.