On October 29, 2019 Promising research from Exact Sciences Corp. and Mayo Clinic shows new methylation and protein markers detect colorectal cancer and advanced adenomas with high accuracy (Press release, Exact Sciences, OCT 29, 2019, View Source [SID1234549969]). Findings from the blinded, case-control study were presented at the American College of Gastroenterology’s (ACG) 2019 Annual Scientific Meeting today. The study is part of an effort to increase specificity of Cologuard, while maintaining its high level of sensitivity. Working in collaboration with Mayo Clinic, Exact Sciences has identified novel markers and improved laboratory processes to help achieve its performance enhancement goals and has initiated a 10,000-patient prospective study to validate the performance of the enhanced test.

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The new markers were tested alongside the current Cologuard markers on 725 stool samples, including 117 colorectal cancers (CRC), 120 advanced adenomas (AA), 161 non-advanced adenomas (non-AA), and 327 controls. Results showed 92% CRC sensitivity and 65% AA sensitivity at 92% specificity for the new markers. In this study, the new markers exceeded the specificity and sensitivity of the markers currently used in Cologuard.

Current markers * 87%
specificity

New markers

92% specificity

Difference

CRC sensitivity

88%

92%

+4%

AA sensitivity

53%

65%

+12%

Re-weighted AA sensitivity **

39%

46%

+7%

*Cologuard performance was established in DeeP-C, a prospective study of 10,000 average-risk, asymptomatic patients. The data displayed in this table show performance in a smaller case-control study of 725 samples.

**AA sensitivity re-weighted to match distribution by size of adenoma found in DeeP-C. AA sensitivity is expected to be lower in a prospective study.

"The data presented at ACG are promising," said Kevin Conroy, chairman and CEO of Exact Sciences. "This new study demonstrates the potential to make Cologuard, an accurate, convenient screening option, even better for patients and gives us confidence to move forward with a prospective study. We look forward to generating additional evidence, making an enhanced test available to patients, and solidifying Exact Sciences as the leader in the early, accurate detection of colorectal cancer."

To establish the sensitivity and specificity of the novel multi-target stool DNA test, Exact Sciences recently launched the BLUE-C study, a multi-center, prospective study, with the first patient expected to enroll this November. More than 10,000 patients 40 years of age and older and scheduled for a CRC screening colonoscopy will be enrolled. Patients will collect a stool sample and perform a commercially available fecal immunochemical test (FIT) prior to screening colonoscopy. Patients will be invited to provide a blood sample that Exact Sciences intends to use for validation of a potential blood-based screening test for CRC. Collecting stool and blood in one study is expected to provide significant cost and timing efficiencies.

Screening for CRC can help save lives by preventing the disease or detecting it early.1 Tests that can help accurately detect AAs and early-stage CRC provide the best chance of preventing or treating the disease before it progresses. CRC invades more layers of the colon wall and the blood supply as it advances, making it difficult for blood-based tests to accurately detect early-stage disease.2 Even with this biological limitation, blood-based tests could provide another option to get more people screened.

"While further studies will establish the clinical performance of these new markers, we are encouraged by the strong results presented today," said Paul Limburg, MD, MPH, AGAF, chief medical officer of Exact Sciences and gastroenterologist at Mayo Clinic. "The discovery of these markers by the Exact Sciences and Mayo Clinic teams is fueled by our spirit to continuously improve and advance the fight against this deadly disease."

About the BLUE-C study
The primary objective of this multi-center, prospective study is to determine the sensitivity and specificity of a novel multi-target stool DNA (mt-sDNA) screening test for CRC, using colonoscopy as the reference method. Lesions will be confirmed as malignant by histopathologic examination. Patients 40 years of age and older who are scheduled for a CRC screening colonoscopy will be eligible to participate. After providing written consent to participate in the study and before a screening colonoscopy, subjects will be provided with a stool collection kit and will collect a stool sample for the mt-sDNA screening test and for a commercially available FIT test. Subjects will undergo colonoscopy within approximately 60 days of enrollment. Subjects and clinicians will remain blinded to the results of the mt-sDNA CRC screening test and the FIT test, which will not be used in clinical management. Enrolled subjects will have the option to enroll in a blood collection sub-study for the development of a potential blood-based screening test for CRC.