On October 7, 2020 Exact Sciences Corp. (Nasdaq: EXAS) and Pfizer Inc. (NYSE: PFE) reported an extension and amendment of their agreement to promote Cologuard, the first and only FDA-approved non-invasive stool DNA screening test for colorectal cancer (Press release, Exact Sciences, OCT 7, 2020, View Source [SID1234568180]). Under terms of the nationwide agreement, Pfizer will continue to provide marketing and related support for Cologuard and join Exact Sciences’ efforts to educate patients, physicians, and health systems about Cologuard.
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The COVID-19 pandemic has highlighted the need for convenient, accurate cancer testing options. Outcomes can be dramatically improved if colorectal cancer is caught in early stages, and with more than an estimated one million screening colonoscopies missed this year, there is an urgent need to increase screening rates.1 Cologuard is an accurate, at-home colon cancer screening option and is uniquely positioned to support screening during this time and after the pandemic abates.
"We’re thrilled to continue working with Pfizer to increase screening rates with Cologuard, especially during this critical time," said Kevin Conroy, chairman and CEO of Exact Sciences. "Over the past two years, Pfizer has shown incredible commitment to Exact Sciences’ goal of eradicating colorectal cancer by helping detect the disease at its earliest, most treatable stages. The talented Exact Sciences team is excited to continue joining forces with Pfizer to help improve screening rates among the 46 million unscreened Americans."
In the two years since the partnership began, more than 3 million people were screened with Cologuard and more than 90,000 healthcare providers ordered Cologuard for the first time. The combined teams have also introduced several new direct-to-consumer marketing campaigns and worked with dozens of large health systems to improve colorectal cancer screening rates.
"Now more than ever, Pfizer’s purpose – breakthroughs that change patients’ lives – has taken on an even greater urgency. This partnership is a testament to that purpose, and Pfizer is incredibly proud of the work we have done with Exact Sciences to raise colorectal cancer screening rates," said Mike Gladstone, Global President of Internal Medicine at Pfizer.
Under the terms of the amended agreement, Pfizer will provide sales and marketing support through the end of 2022 and health system support through the end of 2021. Exact Sciences will compensate Pfizer based on the amount of services provided, along with additional fixed and performance-related fees set forth in the agreement. Exact Sciences will maintain responsibility for all aspects of manufacturing and laboratory operations of Cologuard.
More information about the agreement is available here, in a form 8-K that Exact Sciences has filed with the Securities and Exchange Commission.
About Cologuard
Cologuard was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use Cologuard if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. Cologuard is not a replacement for colonoscopy in high risk patients. Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. Cologuard performance in repeat testing has not been evaluated.
The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again.