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Technical Info
The mission of Stage I Diagnostics is to commercialize a test system that can detect
cancers in the earliest stages of the disease – in effect, in stage I of the
disease. We believe that there is a significant market need for reliable early stage
screening tests for cancers of the reproductive tract, and especially, ovarian cancer.
Currently, ovarian cancer is only rarely detected in its early stages. However,
detection in stage I of the disease greatly enhances the treatment outcome for patients
as evidenced by the data in the accompanying chart. Using current technology, only
about 20% of all women have their ovarian cancers detected in stages I and II of
the disease, where it is the most treatable. According to the American Cancer Society,
of the 80% of women whose cancers are not detected until stages III and IV, only
20% survive for longer than five years. Ovarian cancer rarely exhibits noticeable
symptoms until it progresses to its latter stages and because of this, it is known
as the “silent killer.” There is a compelling need to develop reliable,
accurate test systems to detect ovarian cancer at its earliest stages, when treatment
options provide women a fighting chance at long term survival.
Stage I has an advantage in the development of screening tools for cancers of the
ovary, prostate, breast and cervix because of the breadth of our intellectual property.
We currently possess in-licensed proprietary rights to 14 tumor markers that we
have identified as being present in all four types of cancers that we have targeted.
Some of these antigens are also present in more than one type of cancer. Stage I
can use a panel of antigens to detect cancer in patients instead of relying on just
one single antigen and also develop several panels that cover different cancer types
from this set of tumor markers. By using a properly selected panel in our test systems,
we believe our test systems’ reliability will be superior to a single marker
test.
As of June 30, 2004, we had licensed the rights to 14 issued United
States patents; 6 issued foreign patents, 21 pending United States patent applications,
and 10 pending foreign applications. Our pending foreign filings will cover Europe,
Japan, North America and Australia.
Analysis of the data contrasts our panel of markers with the CA125 test system.
CA125 is the current marker of choice for ovarian cancer. Among our group of markers,
while no single one is present in all of the tested tumors, the marker group treated
as a panel or array is present in all of the 53 tested early stage tumors. The success
rate in detecting all tumor types, using CA125 alone, could be significantly lower
than the success rate of the entire group of markers comprising Stage I’s
OvaStage™ test system.
Our solution to the market need for more reliable early stage screening
tools for cancers is to use a panel of markers in our test systems. Using a panel
improves our chances for early detection of a tumor. Tumors have individual marker
profiles and as such several markers are necessary to accurately detect early stage
disease. With ovarian cancer there are four distinct major tumor types. Each of
these types produces a varying set of markers with some markers present in one type
and absent in another. The levels of expression of the markers are also very different
from type to type. Our panel, constituting the OvaStage™ test system, including
CA125, covers all four of the major types of ovarian cancer. By using the OvaStage™
panel, we believe that we can greatly improve detection capabilities, enabling earlier
and better treatment outcomes for the great majority of ovarian cancer patients.
ProStage™ will be our product for the early detection of prostate cancers.
ProStage™ will consist of a panel of our tumor markers that will enable us
to detect prostate cancer in its earliest stages and also to discern the difference
between benign prostate disease and malignant tumors. We know that a number of our
markers are prevalent in prostate cancer and we are conducting preclinical work
to determine the optimum panel to allow early detection of malignancy.
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