Mr. Hardison: Our company was founded back in 1995 by Stan Lapidus who had also founded Cytyc Corporation prior to EXACT Sciences. Shortly thereafter, he hired a very bright young scientist named Tony Shuber who is now our CTO. At that time they started working on the challenge of how to isolate human DNA from a stool sample, with the idea of developing a company focus that would be the early detection of colorectal cancer. So from that time up until August 13 of this year, when we launched our first major product, we have been working on improving the proprietary technology that came from those early days that will allow us to detect colorectal cancer early, and getting ready to bring this technology to the market. We are very fortunate that we now have our first major assay for the early detection of colon cancer, called PreGen-Plus_, on the market today.
TWST: Could you describe this product in layman's terms and tell us how
it differs from existing ones?
Mr. Hardison: Our product, in one sense, is very simple. What we do is
take a stool sample, isolate human DNA from that sample, and then look
for specific mutations in the sample that are known to be associated
with colorectal cancer. If you get a positive result on our test, you
should be referred to a colonoscopy, which becomes the diagnostic. So
our test is a screening test, much like a pap smear is a screening test
for cervical cancer. If you get a negative result on our test, you
should be told to come back in the next year to three years to be
screened again, much like women are told when they are screened with a
pap smear. Our test, PreGen-Plus, is more sensitive for colorectal
cancer than any other non-invasive test currently on the market. The
only other test that has a higher sensitivity for colorectal cancer is a
colonoscopy.
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