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Applications
Disease Genotyping
Pharmaceutical companies
are leveraging advances in genomics and proteomics to
develop targeted medications for patients. While the
development of new drugs will heighten the efficacy of
therapy, the interference of the genetic make up of the
disease creates ongoing challenges for physicians
treating patients. Today, cancer can be diagnosed to a
specific tumor class for medical treatment, yet
successful therapy is dictated specifically by the
genetic abnormalities of the tumor cells. Treatment of
cancers and other genetic diseases is often slowed by
non-specific medications, which also typically generate
severe side effects. The medical community embraces the
ability to genotype disease for therapy yet few medical
institutions are currently using it as a result of cost
pressures. The introduction of a new technology capable
of rapidly sequencing genomes to identify specific
genetic characteristics of a disease will allow
physicians to prescribe the appropriate and most
efficient treatment for patients.
Disease Susceptibility
Despite the increasing
availability of genomic information, physicians still
have little means to determine a patient's risk to
disease. Currently, newborns are screened for health
deficiencies via bacterial inhibition assays, which
inherently limit the range of diseases screened and
which only provide a diagnosis of the current state of
the child. In fact, current medical technologies allow
diseases - in all age groups - to be diagnosed and
treated only at onset. The inability of the medical
community to diagnose a disease before onset commonly
leads to additional complications and even death.
While the U.S. records an
average annual birth rate of 4 million, cancer alone
accounts for 500,000 annual deaths. The American Cancer
Society attributes this mortality rate to late diagnosis
and delayed treatment, and concludes that early
diagnoses would reduce this rate significantly. In
addition, the 8 million undiagnosed diabetes patients in
the U.S. will likely be diagnosed with blindness, kidney
failure, and chronic heart failure if left untreated.
The large demand for early diagnosis can be met by a
technology capable of allowing rapid and affordable
human genetic analysis.
Homeland Security
Biological weapons are
among the most dangerous weapons in the world. With some
nations currently pursuing offensive biological warfare
programs and the ability of engineered pathogens to
evade current treatments, the urgent need to rapidly
sequence suspected biological warfare agents is
apparent. The ability to obtain sequence data for
genetically engineered pathogens can lead to the
development of new treatments, and will assist the
government in creating a library to identify the
ultimate source of those pathogens. The Department of
Defense is stepping up its efforts to combat terrorism.
The 2002 budget request for defense against terrorism
increased 7% to $10.3 billion, with $1.76 billion
devoted to the defense against weapons of mass
destruction. While the government has no current
solution to quickly identify novel biological warfare
agents, new technologies that can sequence pathogens in
minutes will assist in meeting this need.
Sequencing Services
Third party sequencing
services are provided by -600 Contract Research
Organizations (CROs). Despite a few major players, this
service market is highly fragmented, and competition is
fierce. To address the increasingly competitive space,
companies have sought strategies that include: (1)
merger and acquisition to diversify services (2) global
expansion (3) niche services, and (4) increasing
services on the front and back end. Given a new
technology that expands their capabilities and reduces
their cost structure, CROs can improve their respective
competitive advantages and generate stronger customer
loyalty.
Increasing Organism
Genome Sequencing
Researchers today are
busy sequencing whole genomes of model organisms and
infectious organisms, in hopes that such information
will help both identify new genes and understand the
biological mechanisms underlying disease. VisiGen's
performance capability will remove the inefficiencies
currently preventing large scale sequencing by a broader
group of researchers. The substantial cost and
time-savings will encourage more researchers to engage
in sequencing activities and support decisions to begin
sequencing projects on organisms currently considered
'non-viable' due to cost and effort concerns. The
National Human Genome Research Institute (NHGRI)
continues to prioritize the next organisms to be
considered for entry into the sequencing pipeline. As
researchers submit additional white papers to NHGRI,
more organisms will be added to the priority groups that
can be sequenced by the centers. Several institutes,
including the USDA, have already expressed interest in
supporting additional sequencing efforts in the future.
Agriculture
A growing demand for
sequencing information exists in both the plant and
animal agriculture markets; however, current
inefficiencies have not addressed the market needs.
Given greater sequencing capabilities, researchers can
begin sequencing projects that will lead to improved
crop production and plant utilization. The animal
agriculture market, a $240 billion worldwide market
(source: USDA), can benefit from sequencing information
that would improve productivity and pathogen resistance.
Comparative Genomics
Comparative genomics is
another growing genomics application requiring DNA
sequencing or genotyping. Comparative genomics involves
sequencing specific DNA regions in many organisms and
allows researchers to compare genetic variations across
and within species, yielding clues as to which
variations play a role in disease. VisiGen was invited
to present its technology at the August 2004 NIH
workshop addressing a large-scale human re-sequencing
effort.
More generally,
comparative genomics allows biologists to peruse
evolution's laboratory notebook-to identify conserved
functional features and recognize new innovations in
specific lineages. As an example, primates and other
organisms that will help define key developments along
the vertebrate and nonvertebrate lineages are being
sequenced.
Personalized Medicine
VisiGen
will target hospital applications over the longer term
as genome sequencing costs reach attractive price points
($10K-$1K). Given the ability to sequence genomes
rapidly and cost effectively, physicians will have
several capabilities that were never before possible:
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Doctor's will have the ability to diagnose a
patient's risk to disease from as early as birth.
This knowledge will assist physicians in developing
life-style maps that suggest to patients activities
that will address disease prevention
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Disease risk information will encourage regular
screening of disease to which a person is
susceptible. Early diagnosis of diseases, such as
cancer, will prevent additional complications that
would have otherwise occurred with late diagnosis.
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The
physician will have the capability to prescribe
medications that best suit a patient's genetic
profile and thus improve medical therapies.
The potential markets and
applications are almost limitless once genomic
information can be collected and analyzed quickly,
accurately, and economically.
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