| THE
MARKET
Upstream's initial genetic predisposition markers complement
existing detection tests, are targeted against liver, prostate, ovarian
and thyroid cancer with a market potential of over a billion dollars.
MARKET DRIVERS
Dr. Janet Woodcock, FDA Deputy Dir. Operations: "We hope ultimately
to bring pharmacogenomics to every healthcare professional's prescription
pad.”
– March 22, 2005
WHY NOW?
- Collapse in the cost of DNA testing
- 2000: $5-$10/SNP
- 2005: $0.05/SNP
- Critical mass of public data
- Next release of HapMap
- Land Rush to mine for IP
- Clinics adopting DNA Testing platforms
- Insurance reimbursement established
- Upstream’s Fast Follower Advantage
- Low cost of biomarker discovery
- Won’t have to invest in the testing platform
- Downstream diagnostic supply chain in place
- Post-FDA Mandate
DISEASE SUSCEPTIBILITY
Liver, Prostate, Ovarian, and Thyroid Cancer Early Detection
LIVER CANCER
There are more than 500,000 new cases of liver cancer worldwide each
year, with an overall 5-year survival rate of about 9%.* Liver Cancer
is one of the most aggressive types of cancer typically resulting in
death in under 4 months after diagnosis. Early detection could increase
the survival rate to 40%, since early surgical intervention can prevent
death. The current gold standard detection test is AFP – alpha
feto protein – and a predisposition test could complement it.
Physicians could use Upstream's liver cancer susceptibility test to
determine which patients need early detection AFP testing and the frequency
of testing. Family members of liver cancer victims represent a market
of 100M people worldwide.
- 90% of liver cancer discovered too late to
operate
- Liver cancer patient overall 5-year survival
rate is 9%
- If found early, 40% of patients could survive
PROSTATE CANCER
Prostate Cancer is the leading cause of cancer in men in the US and
according to the American Cancer Institute, prostate cancer is the second
leading cause of cancer death in men in the US . Upstream intends on
using its prostate cancer genetic markers to develop diagnostic tests
to complement the existing Prostate Cancer Antigen (PSA) screening method.
The PSA test is the most common test for prostate cancer and more than
40 million men in the US undergo PSA testing every year and spend >$200
million annually. The Centers for Disease Control reported that 75 percent
of men aged 50 and older reported that they have undergone PSA testing
at least once. According to the National Institute of Cancer, the PSA
test can fail to detect prostate cancer in some patients and lead to
unnecessary biopsies for many others. Only 25 to 30 percent of men who
have a biopsy due to elevated PSA levels actually have prostate cancer.
There are 230,000 men newly diagnosed with Prostate Cancer and 30,000
deaths each year in the US. The current prostate early detection test,
based on PSA levels, typically misses 60% of cancers and leads to unnecessary
biopsies. Upstream’s diagnostic markers could decrease the number
of unnecessary biopsies and increase the likelihood of early detection
by identifying which patients have a genetic risk of developing prostate
cancer. Physicians could use Upstream's prostate cancer susceptibility
test to complement PSA testing.
- Don’t know who to biopsy
- Prostate cancer PSA tests miss 60% of the
cases
- A predisposition test could personalize
PSA thresholds, reducing unnecessary biopsies and increasing accurate
diagnosis
OVARIAN CANCER
According to the American Cancer Society,
Ovarian cancer ranks fifth in cancer deaths among women, accounting
for more deaths than any other cancer of the female reproductive system.
It is estimated that there will be about 15,310 deaths from ovarian
cancer in the United States during 2006. Furthermore, the American Cancer
Society’s research states that if ovarian cancer is found early
and at a localized stage about 94% of patients will live more than five
years after the cancer is diagnosed, but presently only 20% of ovarian
cancers are found at an early stage. By finding cancerous cells
early it significantly improves the chances for successful treatment.
Upstream's diagnostic markers could potentially increase the likelihood
of early detection by identifying which patients have a genetic risk
of developing the disease.
THYROID CANCER
The American Cancer Society estimates
that in the year 2006 about 30,180 new cases of thyroid cancer will
be diagnosed in the United States. The disease is much more common in
women than men, and of the new cases diagnosed, about 22,590 will occur
in women, and 7,590 in men. Nearly two-thirds of people are diagnosed
between the ages of 20 and 55. In the United States alone, an estimated
870 women and 630 men will die of thyroid cancer during the year 2006.
UPSTREAM’S SOLUTION: Personalized Medicine
using Molecular Diagnostics
Big Opportunity in Diagnostics, Growing Fast
- The global molecular diagnostic market
$6.1 Billion (2003)*
$12.6 Billion (2009 projection)*
$100M’s revenue from each test*
- Cancer diagnostic market:
Expected to hit $7.4 billion by 2009. North America, with only 5 percent
of new cancer patients worldwide, accounts for nearly 44 percent of
the worldwide cancer diagnostics market.
- FDA requires validated biomarkers data submitted
with IND
Upstream uses its datamining pipeline and bioassay to develop
DNA diagnostics which:
- Predict patients’ reactions to drugs
- Drug Response
- Predict patients’ risks of disease
- Susceptibility
- Suggest early detection tests for at-risk
patients
- Suggest individualized course of treatment
The Molecular Diagnostics market is currently $6.1B annually and estimated
to reach $12.6B by 2009. A single diagnostic test can generate $100M
in annual revenues.*
|
