biocentury: Content meets conduit
By Steve Edelson
One of the problems with the new economy is that there’s
always been more bandwidth than content. The same can be said
for companies developing SNP genotyping technologies. A case
in point is Illumina Inc., which by all accounts has done a good
job executing its strategy of offering customers a complete set of
systems for SNP genotyping and gene expression. Indeed, first
quarter sales of the company’s products
came in at $23.3 million, up 91% from
$12.2 million in the same quarter in 2005.
But ILMN has always aspired to layer a
diagnostics capability on top of its
genotyping products, and that requires
content. The company last week took its
first major step down the DNA diagnostic
path via a deal with deCode genetics Inc.
The partnership combines ILMN’s SNP
genotyping products with biomarkers from
DCGN (Reykjavik, Iceland). Initially, the
companies plan to develop and commercialize diagnostics for
variants in three disease-related genes: the leukotriene A4
hydrolase gene, the gene for transcription factor 7-like 2 and the
gene encoding BARD1. The first gene is related to heart attacks,
the second is linked to Type II diabetes and the third is associated
with breast cancer.
The companies hope these diagnostics will be the tip of the
iceberg and that applying ILMN’s technologies to DCGN’s
population genetics database will yield additional genetic markers
of disease. The deal will also help ILMN’s near-term revenue
stream, as the company will install its SNP genotyping platform
at DCGN.
“This is our biggest system installation yet, and should be
online in six to eight weeks,” ILMN President and CEO Jay Flatley
told BioCentury.
ILMN (San Diego, Calif.) will be providing its full product line,
including Sentrix HumanHap 300 BeadChips for disease association
research; Infinium assay and laboratory information management
system; and BeadStudio software for data analysis and
visualization.
“To give a sense of scale, our list price in the U.S. is about
$900 per HumanHap 300 chip,” said ILMN spokesperson William
Craumer. “deCode has 100,000 samples — clearly they
won’t pay list price, but this is still the largest SNP genotyping
deal in the world.”
Flatley added that ILMN’s large deals for its systems typically
are done at about a 50% discount, and that DCGN’s discount
would likely be even more.
But in addition to the near-term revenues, ILMN’s longer term
focus includes the clinical diagnostics space, which requires
content. The company’s first content-related deal was in 2004,
when ILMN partnered to identify markers of metabolic syndrome
with Genomas Inc. (Hartford, Conn.).
“At that time, it was clear to us that it was only a matter of
time before we entered the clinical diagnostic market,” said
Craumer. “The deal with deCode is the first major plunge into
that space.”
ILMN has said it expects to sign at least one more major
diagnostic deal in 2006. But beyond the clinical diagnostics
space, the company wants to be a player in predictive diagnostics.
The difference is important, said Craumer. “Clinical diagnostics
will always be phenotype constrained,” he said. “You tell the
doctor your symptoms, they run a test, and patient and doctor
decide what to do about it. There’s a
broader and deeper market for predictive
diagnostics.”
An example would be testing African
Americans for variants of the gene encoding
leukotriene A4 hydrolase. According
to Flatley, that population has “a 3.5 times
higher relative risk of MI if they have that
marker. That group might want to have
the test at a much earlier age.”
Technically speaking, he added, developing
predictive diagnostics “is straightforward
— the breakthroughs will be on the reimbursement side.”
For its part, DCGN wants to use its content for dual purposes
— therapeutic development plus accompanying diagnostics for
its compounds. The company expects ILMN’s technology will
allow it to drill deeper into its population genetics databases and
will tease out more targets for therapeutic and diagnostic
development.
“Thus far, we’ve used our internal technology to pull out
disease-associated genes and their variants,” said CEO Kari
Stefansson. “Now, we want to dive in and look at our phenotypic
data in the context of high density SNPs,” which could help shake
more targets out of the data.
“You could argue that we’re trying to double-dip in the
usefulness of our data,” added Stefansson. “That’s because it has
value not only for developing therapeutics but also for diagnostics.”
DCGN expects that a single therapeutic could have multiple
accompanying diagnostics. A case in point is the company’s
DG031, a small molecule inhibitor of 5-lipoxygenase activating
protein (FLAP). Inhibition of FLAP results in decreased production
of leukotriene B4, a cytokine that causes inflammation in
atherosclerotic plaques.
Last week, DCGN started a Phase III trial of DC031 to prevent
heart attacks in African Americans with recent history of heart
attack. The trial will enroll patients with and without the
leukotriene pathway gene variants associated with MI (see B16).
On the diagnostic side, there could be multiple tests that
accompany DC031.
For example, said Steffanson, “a genetic test could be
used to identify a subset of individuals who can benefit from
a drug like DC031. But it doesn’t identify everyone who
could benefit — the leukotriene pathway could be upregulated
because of your genetics, but it also could be upregulated
because you have chronic infections. Thus, in
addition to the genetic test, I’d want a test that measures
actual output of the leukotriene pathway.” |
