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: Company / Organization Categories
Nomination Sub Category: Company of the Year - Health Products & Services

Nomination Title: Exact Sciences: Company Turnaround Leads to a New Chapter in Cancer Detection

Tell the story about what this nominated organization has achieved since January 1, 2014 (up to 650 words). Focus on specific accomplishments, and relate these accomplishments to past performance or industry norms. TEXT REDACTED FOR PUBLICATION

In 2009, Exact Sciences was a struggling public biotech company fighting to stay afloat after several early product failures. The company had $26 million in cash and four employees, three of whom were leaving. Just six years later, the company is a recognized leader in life sciences and one that is reshaping the industry by shifting disease detection to the earliest stages when it is most treatable. Last year marked the culmination of Exact’s turnaround story and the beginning of a new chapter in cancer detection.

Six years ago, Exact had little more than an idea for a better screening test for colorectal cancer (CRC). Considered one of the most preventable, but least prevented cancers because 23 million Americans skip recommended screenings, CRC remains the second deadliest cancer. This low rate of compliance is a result of many people avoiding a colonoscopy. Exact set out to change these statistics and help eradicate CRC.

Confident that they had something worth fighting for, Exact overhauled its leadership team in April 2009, bringing in Kevin T. Conroy as president and CEO and Maneesh Arora as VP and CFO, along with new executive and R&D teams. The company moved from Boston to Madison, Wisconsin and went on to raise more than $700 million.

Under the stewardship of Chief Medical Officer Dr. Barry Berger and Chief Science Officer Dr. Graham Lidgard, Exact partnered with Dr. David Ahlquist and the Mayo Clinic. Long-term scientific collaborators, they formed a partnership that would help take the idea of a patient-friendly, noninvasive, stool-based DNA screening test for CRC across the finish line. The move to bring together Mayo’s scientific and clinical expertise with Exact’s revamped R&D team accelerated progress and resulted in what is now known as Cologuard.

Exact Sciences then enrolled more than 10,000 patients in the largest clinical trial in CRC screening ever conducted. The DeeP-C study found that Cologuard was effective in detecting CRC and precancerous polyps. It was a turning point for the company and in the war on cancer.

Exact was then approached to participate in the joint U.S. Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services’ (CMS) Parallel Review Pilot Program where both agencies review medical technologies simultaneously, expediting the process for bringing life-saving innovations to patients. Participation was a risk—it could save time and years of regulatory review, or bring the entire project to a halt. The gamble worked.

In March 2014, the trial results were published in the New England Journal of Medicine (NEJM). In August 2014, Cologuard received FDA approval, becoming the first and only noninvasive stool DNA test for CRC approved by the FDA and the first product approved under the Parallel Review program. In November, CMS announced that it would cover the test, making Cologuard immediately available to millions of Medicare recipients.

Since approval, momentum has accelerated. Mayo Clinic became the first healthcare system to offer Cologuard and several others are signed on. Exact opened a state-of-the-art lab capable of processing up to 1 million Cologuard tests each year and operates its own call center to help increase patient compliance. This high-touch approach is unique to Exact and groundbreaking in the field of diagnostics.

In just six years, Exact has gone from near extinction to millions in cash, its stock price has surged and its team has grown to more than 600. With a potential market of 80 million Americans between age 50 and 85, the company could see annual revenue of $2 billion in the U.S.

A scientific achievement with broad potential application, Cologuard embodies the company’s long-held vision for improving the way we screen for a range of cancers in the earliest stages of disease when they’re most preventable and survivable. After a long journey back from near extinction, this is only the beginning for Exact Sciences.

In bullet-list form, briefly summarize up to ten (10) of the chief accomplishments of this organization since the beginning of 2014 (up to 150 words).

1. Publication of the DeeP-C clinical trial results in the New England Journal of Medicine
2. Completion of the first-ever FDA/CMS parallel review, FDA approval and Medicare coverage decision for Cologuard
3. Multiple health systems (incl. the Mayo Clinic, Meriter-UnityPoint Health, Mercy, MDVIP and Group Health Cooperative) and more than 5,000 physicians signed on to offer Cologuard to patients
4. Opening of a state-of-the-art lab in Madison where all Cologuard tests will be processed, a call center to support patients, and a program to help doctors track patient compliance
5. Inclusion of Cologuard in the American Cancer Society's Colorectal Cancer Prevention and Early Detection national guidelines
6. Growth of the company’s headcount to more than 600

Of the following measures of success, which ONE do you want the judges to most appreciate about your organization's story of achievement since the beginning of 2014?

Overall Innovation