Exact Sciences and Mayo Clinic said today they will expand their six-year-old collaboration to develop screening, surveillance, and diagnostic tests beyond their original colorectal cancer partnership, to address other diseases within the gastrointestinal tract.
The value of the expanded collaboration was not disclosed—though Exact Sciences said it would extend for five years its collaboration with Mayo Clinic gastroenterologist David Ahlquist, M.D., and his lab.
Dr. Ahlquist co-invented the diagnostic technology that has been licensed to Exact Sciences from Mayo Clinic. Under that agreement, Mayo Clinic and Dr. Ahlquist share in equity and royalties. Mayo Clinic has agreed to use the revenue it receives to support its not-for-profit mission in patient care, education, and research.
Exact Sciences said it will continue to have rights to intellectual property developed through the collaboration, including patents, know-how, and new markers.
Exact Sciences and Mayo launched their original collaboration in 2009, with a focus on colorectal cancer diagnostics. The partnership led to the development of Cologuard®, approved by the FDA in August 2014 as the first noninvasive DNA screening test for colorectal cancer. Cologuard is designed to analyze both stool DNA and blood biomarkers through at-home use by adults 50 years old and older.
Cologuard also has two additional “firsts”—the first stool-based diagnostic designed to indicate the presence of abnormal growths in red blood cells and DNA mutations, and the first test to be approved under a joint parallel review pilot program by the agency and the Centers for Medicare and Medicaid Services (CMS).
“Our ambitions cannot end with Cologuard. We expect our collaboration to continue producing breakthroughs that can change patients’ lives,” Kevin Conroy, CEO and chairman of Exact Sciences, said in a statement. “By expanding our relationship with Mayo Clinic, we have an opportunity to build on our shared successes and continue looking for new opportunities to take on some of the deadliest forms of cancer.”
During 2014, Exact Sciences generated an estimated roughly $1.5 million from Cologuard, the company said on January 12, citing preliminary data.
Exact Sciences said it completed and reported diagnostic results for 4,024 Cologuard tests, while more than 4,000 physicians wrote at least one prescription for the test. The patient compliance rate was 74.6% as of December 31.
And on January 28, Exact Sciences said that Norton Healthcare became the first provider in Kentucky to offer Cologuard.
According to the company’s Form third-quarter 2014 Form 10-Q, filed October 31, 2014, with the U.S. Securities and Exchange Commission, the original collaboration agreement had Exact Sciences paying Mayo Clinic $80,000 upfront, then a $250,000 milestone payment in June 2011 upon the start of patient enrollment in a human cancer screening clinical trial, followed by a $500,000 payment in August 2014, tied to FDA approval of Cologuard. As of September 30, 2014, the company also recorded a $1.6 million liability for Mayo R&D efforts.
The collaboration also called for Exact Sciences to make royalty payments to Mayo based on a percentage of net sales of products developed from the licensed technology starting in the third year of the agreement. The minimum annual royalty payment was $10,000 in 2012, then $25,000 each year from 2013 through 2029.
In 2012, Mayo agreed to expand Exact Science’s license to include all gastrointestinal cancers and diseases, and new cancer screening applications of stool- and blood-based testing.