Company: Exact Sciences, Madison, WI
Entry Submitted By: MSLGROUP
Company Description: Exact Sciences Corp. is a molecular diagnostics company headquartered in Madison, Wisconsin and focused on the early detection and prevention of colorectal cancer. The company developed and commercialized the first and only non-invasive stool DNA test approved by the FDA for colorectal cancer screening.
Nomination Category: New Product & Service Categories
Nomination Sub Category: Health & Pharmaceuticals - Product

Nomination Title: Exact Sciences' Cologuard

Tell the story about this nominated product or service (up to 650 words). Describe its function, features, benefits, and performance to date.

Cologuard, developed by Exact Sciences and approved by the FDA in August 2014, is a noninvasive screening test for colorectal cancer (CRC) designed to help increase rates of screening compliance and eradicate America’s second deadliest form of the disease.

CRC is the most preventable, yet least prevented cancer. Guidelines call for men and women at average risk to begin CRC screening at age 50 and earlier if there is a family history. Unfortunately, 23 million Americans in this age group skip life-saving screening, which is critical because CRC is highly treatable when caught early. As a result, more than 60 percent of all CRC cases are not detected until the late stages, making treatment difficult and survival rates low.

Colonoscopy is the standard for diagnosing CRC. It’s an invasive procedure that requires bowel preparation, including a clear liquid diet and laxatives, sedation, time off from work, and transportation to/from the test. As a result, many patients avoid it. Another tool, called sigmoidoscopy, takes less time, is still invasive, requires prep and sedation and doesn’t screen the entire colon.

Other options, such as the fecal occult blood test (FOBT) and fecal immunochemical test (FIT), were developed as noninvasive screening options. Both are designed to detect blood in the stool not seen by the naked eye. However, because there are unrelated conditions that can cause blood in the stool, and not all polyps or lesions bleed, these tests may not be reliable on their own for the detection of cancer.

What’s been lacking is an accurate, noninvasive screening option that will encourage people to comply with screening guidelines and improve the chances of early detection. Until now.

Cologuard is a game changer in the war on cancer. It looks not only for blood, but also for altered DNA from abnormal cancerous or precancerous cells that are shed into the stool as it passes through the colon. It is a completely new technology that uses a complex molecular process to capture DNA for analysis and search for 11 distinct biomarkers, including blood, known to be associated with CRC and precancerous polyps.

It is the combination of DNA and blood detection that makes Cologuard an accurate and powerful new tool. A pivotal study of 10,000 patients—the largest clinical trial in CRC screening ever conducted in the U.S.—found Cologuard was accurate in identifying 92 percent of cancers and 69 percent of the most advanced precancerous polyps in average risk patients with a specificity of 87 percent. The results were published in the New England Journal of Medicine in March 2014.

The Cologuard process is simple and easy. First, a physician prescribes the test and a collection kit is sent to the patient’s home. The patient collects a stool sample in the privacy of his/her home—no medication, dietary restrictions, bowel preparation, sedation, time off of work or transportation required—and sends the kit back to the lab for testing in a pre-paid UPS mailer. The patient receives one of two results from his or her doctor: positive or negative. If positive, the patient is referred for a diagnostic colonoscopy.

Since FDA approval, multiple health systems (including Mayo Clinic) and more than 5,000 physicians have signed on to offer Cologuard to patients and Cologuard is now included in the American Cancer Society’s national guidelines for colorectal cancer screening. Cologuard has received numerous industry accolades, including Popular Science magazine’s 2014 “Best of What’s New” award and Everyday Health Award for Innovation.

A noninvasive, accurate and patient-friendly screening tool, Cologuard represents a significant scientific achievement and major advancement in the battle against CRC. The hope is that by getting more Americans screened, more cancers will be caught in the early stages, leading to improved survival rates. The technology also has broad applications that could one day change the way we screen for and identify, noninvasively, a wide range of cancers in the earliest stages of disease.

In bullet-list form, briefly summarize up to ten (10) of the chief features and benefits of the nominated product or service.

Cologuard is:

• a breakthrough in the fight against colon cancer
• the first and only FDA-approved, noninvasive, stool-based DNA (sDNA) colorectal cancer screening test for asymptomatic adults 50 and over who are at average risk
• simple, easy to use, convenient and patient-friendly
• highly effective in detecting early-stage, curable colorectal cancer and shows significant improvement in the detection of the most dangerous pre-cancers
• eliminates the preparation, sedation and inconvenience inherent with colonoscopy and delivers a greater level of accuracy compared with other noninvasive screening options
• designed to help improve patient compliance with recommended screening and, in turn, improve early detection of the disease and long-term survival rates
• based on complex science that has potential applications for the early detection of a wide variety of other cancers.