A keen interest in prolonging your life

Exact’s test is non-invasive and will be significantly less expensive than a colonoscopy, the current screening gold standard. As President and CEO Kevin Conroy explains in addition to saving lives, conservative estimates show a potential US market of more than $1bn.

Inside the laboratories bustling with activity at Exact Science’s
Madison, WI headquarters, my team’s mission is clear – to save lives by
making the detection of colorectal cancer patient-friendly and accurate.
Everyone who works at Exact Sciences knows the terrible statistics;
more than six hundred thousand people around the world die each year of
colorectal cancer. That’s the equivalent of fifteen hundred 747s
crashing with no survivors. The numbers are enormous, but each case also
represents a person, a parent, a spouse, a sibling, and that is
something that is never far from our minds.

Despite the enormous death toll from colorectal cancer, there is reason for hope. If detected at early stages before symptoms occur, cure rates are very high. And if pre-cancerous polyps can be detected, colorectal cancer can be effectively prevented. The tumour starts as a precancerous polyp, which typically grows over ten to 15 years before becoming a cancer. So, if such polyps can be detected, colorectal cancer can be prevented.

Today, more than half of all colorectal cancers are detected because the patient is experiencing symptoms. In most of these cases the tumours are at advanced stages, survival odds are decreased and treatment options are more costly and severe. The bottom line is that outcomes from this dreaded disease can be greatly improved with effective screening. We believe that a patient-friendly test that reliably detects cancers and pre-cancers will help save countless lives and create shareholder value in the process.

Recent data suggest that roughly 15 million colorectal cancer screening tests are performed each year in the US, which is just a fraction of the nearly 100 million Americans who under the current guidelines should be screened.

Exact Sciences has developed an advanced, affordable and patient-friendly means of detecting colorectal cancer and pre-cancerous polyps.  In fact, it is the only non-invasive way to reliably detect pre-cancers. Unlike colonoscopy, the Exact test requires no bowel preparation or medication restrictions. Patients will be able to use our test in the comfort and privacy of their own homes. There is no need for sedation or missed days of work. Access to the test will be virtually unlimited, as sample collection kits could be distributed to patients and returned to the laboratory by mail.

The Exact Sciences test is designed to detect altered DNA from pre-cancer and cancer, leading to early diagnosis and in many cases the actual prevention of colorectal cancer. By performing our test at regular intervals, most pre-cancers could be detected before cancer develops. As with the Pap smear test, which has nearly eliminated cervical cancer among those regularly screened, it is our ultimate goal to eradicate colorectal cancer with regular and widespread application of an effective and user-friendly screening tool.

We believe the market opportunity in the US alone is more than $1bn annually. This assumes only 30 percent of people over age 50 will receive one test every third year. We own exclusive rights to this test, which we fully expect will detect more than 85 percent of cancers and more than 50 percent of pre-cancers. There is no other test in molecular diagnostics that has as great a market potential as this one.

Currently, Exact Sciences is making tremendous progress toward bringing this test to patients.  Our scientists have been working in close collaboration with doctors at Mayo Clinic in Rochester, MN. In July, Exact Sciences released tissue data that showed using our unique combination of four methylated biomarkers we could detect 100 percent of both colorectal cancers and pre-cancers with 100 percent specificity.

We are unaware of any other markers or combination of markers that has achieved such complete discrimination. The early validation began this fall and we plan to begin our multi-site clinical trial in the second quarter of 2011 with a goal of submission to the Food and Drug Administration in 2012.

We plan to launch the product shortly after FDA approval. Exact Sciences is working with the Centers for Medicaid and Medicare Service to secure coverage of our test upon FDA approval. We are laying the groundwork to commercialise our test. There remain several significant tasks to complete before our test is launched, and these will be carefully planned and executed. The company has engaged key physicians, laboratorians, and payers.

These leaders continue to provide us with valuable insight into the market and how they expect it to change. We are coupling these important perceptions with a thorough review of several cancer screening success stories in our industry, including Digene and Cytyc.

Investors and analysts have been responding favourably to our focus and the preliminary scientific data we have been able to provide regarding our assay.  Piper Jaffray initiated coverage of Exact Sciences in June with an overweight rating.

“Our overweight rating reflects expectations for management’s successful execution of Exact’s next-generation colorectal cancer screening assay commercialisation strategy and we expect investors will be rewarded as near-term milestones are realied,” wrote Piper Jaffray Senior Research Analyst William Quirk. Four other analysts have also initiated coverage of Exact Sciences, each one listing the company as a buy for investors.

I am confident that Exact Sciences is on the right path toward successfully developing and marketing a non-invasive patient-friendly colon cancer screening test. And my confidence grows each time I speak with members of the Exact Sciences team, who have in a short time proven that they have the intellect, desire and commitment to achieve our plan. Working together, we can achieve our goal of reducing colorectal cancer incidence and mortality in the US and around the world.