February 27, 2019

When Innovation Changes Lives

The word “innovation” gets thrown around a lot in healthcare and biotechnology. With potential “breakthroughs” reported daily, it’s hard to separate what is simply another headline from a tipping point, a shift so monumental that it changes millions of lives.

A Tipping Point in Cervical Cancer

In the first half of the 20th century, cervical cancer was the leading cause of cancer death in women. Without a way to easily identify the disease through screening, families lost mothers, sisters and daughters and communities lost friends, neighbors and colleagues.

Enter Georgios Papanicolaou, who invented a way to detect cancer by inspecting cervical cells. Starting in the 1940s, the introduction of the Papanicolaou (Pap) smear changed the course of cervical cancer and became the first screening test widely used for any form of cancer.

Fast forward to today. The American Cancer Society estimates 4,250 women will die from cervical cancer in 2019. Early cancer detection—made possible by screening—and the recent introduction of the HPV vaccine decreased cervical cancer death rate in the U.S. by more than 70 percent since the 1950s. This is a remarkable accomplishment.

There’s still important work around cervical cancer to ensure regular screening and close socioeconomic disparities. That said, we need to acknowledge this decrease in cervical cancer mortality did not come about because of a cure. It is because of the introduction of tools to identify cancers and pre-cancers at earlier, more treatable stages. Simply put: detecting cancer earlier changes lives.

Making Earlier Possible

Ten years ago, we revitalized Exact Sciences and established a mission of playing a role in the eradication of colorectal cancer. In the early days, we hadn’t figured out the science, but we had a vision. With our partners at Mayo Clinic, we believed simplifying colorectal cancer screening would help get more Americans screened. Undeterred, we became laser-focused on our mission. We wanted to create a tipping point for colorectal cancer, not just another headline.

Colorectal cancer is known as one of the most preventable, yet least prevented cancers. Unfortunately, more than one in three Americans age 50 and older are not up-to-date with recommended screening, leading to more than 50,000 deaths each year. This is a number that has not substantially changed in recent years.

Developing a patient-friendly test that offered high sensitivity for detecting colorectal cancer took five years, a 10,000-patient study and the unwavering commitment from our team. In 2014, Exact Sciences received FDA approval for Cologuard, our at-home, noninvasive, DNA-based colorectal cancer screening test. Today, we celebrate helping two million Americans get screened for colorectal cancer with Cologuard.

Two million people. That’s enough to fill Lambeau Field nearly 25 times over. In trying to wrap my head around this number, it’s easiest to think of the people I’ve met: there’s Dorothy, the vegetarian and runner, who didn’t have colorectal cancer on her radar screen “at all;” Greg, who learned about our noninvasive screening at a PGA TOUR Champions event; and Brenda, who calls her nurse practitioner a “guardian angel” for recommending Cologuard.

There’s also Susan Pickering, one of the million Cologuard patients screened this past year. At age 62, Sue had put off colorectal cancer screening, but with encouragement from her physician and a friend, she screened with Cologuard. Sue’s result came back positive and a colonoscopy led to the diagnosis of Stage II colorectal cancer. After surgery and a few rounds of preventive chemotherapy, Sue now has no evidence of disease.

Sue’s Cologuard result didn’t just impact her. She cares full-time for her adult daughter, who has a disability. Reflecting on receiving a positive Cologuard result, Sue shared, “My first thought was not about me, but what would happen to my daughter. If this hadn’t been caught early, I don’t know what would have happened to her.”

The outcome for Sue and her daughter may have been very different if not for early detection through screening. Stage II colorectal cancer typically has a five-year survival rate ranging from 65 to 87 percent, compared to 12 percent for a stage IV diagnosis.

Like Sue, nearly half of the people using Cologuard are previously unscreened. We estimate Cologuard has helped detect as many as 9,400 early-stage cancers and approximately 64,000 pre-cancerous polyps. I don’t toss around the word “innovation” lightly because I believe that true innovation in healthcare can be the tipping point to change lives—for patients and the family and community around them. While we have yet to see the kinds of gains made against cervical cancer, I believe that we are on our way to a tipping point in colorectal cancer.

To me, this milestone is just the beginning. It’s why our team comes to work every day. It’s why we continue to relentlessly pursue earlier detection. Collaborating with Mayo Clinic, we are building on the highest quality science to produce tests patients and healthcare providers not only can use but, most importantly, want to use.

About Cologuard

Cologuard is intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA) and should be followed by diagnostic colonoscopy. Cologuard is indicated to screen adults of either sex, 50 years or older, who are at typical average-risk for CRC. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high risk individuals.

Cologuard is not for high risk individuals, including those with a history of colorectal cancer and advanced adenoma, a family history of colorectal cancer, IBD or certain hereditary syndromes. Positive Cologuard results should be referred to diagnostic colonoscopy. A negative Cologuard test result does not guarantee absence of cancer or advanced adenoma. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. Rx only.