FDA Approves Exact Sciences’ Cologuard®; First and Only Stool DNA Noninvasive Colorectal Cancer Screening Test

Exact Sciences Corp. (NASDAQ: EXAS) announced today that the U.S. Food and Drug Administration (FDA) has approved Cologuard, the company’s noninvasive, stool DNA colorectal cancer screening test. Cologuard is the first noninvasive screening test for colorectal cancer that analyzes both stool DNA and blood biomarkers and has been proven to find 92 percent of cancers and 69 percent of the most advanced precancerous polyps in average risk patients. Cologuard, which is available through healthcare providers, offers people 50 and older at average risk for colorectal cancer an easy–to–use screening test they can do in the privacy of their own home.

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Topics: Exact Sciences News

Exact Sciences Announces FDA Advisory Committee Unanimously Recommends Approval of Cologuard

MADISON, WI. – Exact Sciences Corp. (NASDAQ: EXAS) today announced that the U.S. Food and Drug Administration's (FDA) Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee determined by a unanimous vote of 10 to zero that Exact Sciences has demonstrated safety, effectiveness and a favorable risk benefit profile of Cologuard ®, the company's stool-based DNA (sDNA), non-invasive colorectal cancer screening test.

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Exact Sciences’ DeeP-C Study Results Published in New England Journal of Medicine

Non-invasive, Stool-based DNA Test Shown to Detect 92% of People with Colorectal Cancer compared to 74% for the Fecal Immunochemical Test (FIT)

MADISON, WI. – Exact Sciences Corp. (Nasdaq: EXAS) today announced that results from its DeeP-C pivotal clinical study have been published online in the New England Journal of Medicine. The peer-reviewed study, “Multi-target Stool DNA Testing for Colorectal-Cancer Screening” will also appear in the journal’s April 3, 2014 print issue.

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DeeP-C Clinical Trial Preliminary Top-Line Results

Top-line data show Exact Sciences’ Cologuard test demonstrates 92 percent sensitivity in the detection of colorectal cancer

All endpoints achieved in 10,000-patient trial of non-invasive, convenient DNA-based screening test for colorectal cancer and pre-cancerous polyps

MADISON, WI. – Exact Sciences Corp. (Nasdaq: EXAS) today announced that preliminary analysis shows that the company’s Cologuard colorectal cancer screening test met or exceeded all primary and secondary endpoints of its recently completed DeeP-C pivotal clinical trial. The clinical trial evaluated the test’s use for the detection of colorectal cancer and pre-cancerous polyps.

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Exact Sciences Receives AMGA Distinguished Corporate Partner Award

ORLANDO, FL. – The American Medical Group Association (AMGA) announced today that it will present the AMGA Distinguished Corporate Partner Award on March 15 to Exact Sciences at its 2013 Annual Conference, March 14-16 at the Hilton Bonnet Creek Resort in Orlando.

The AMGA Distinguished Corporate Partner Award is presented annually to a non-medical group organization for providing excellent service and value to medical groups and their patients.

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Exact Sciences Completes Enrollment of DeeP-C Clinical Trial for Colorectal Cancer Screening

More than 12,700 patients enrolled to evaluate the company’s non-invasive stool-based DNA test to detect the second leading cause of cancer deaths.

MADISON, WI. – Exact Sciences Corp. (Nasdaq: EXAS) today announced it has completed patient enrollment in its DeeP-C pivotal trial for colorectal cancer screening. The study enrolled more than 12,700 patients at sites in the United States and Canada.

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New Noninvasive Colorectal Cancer Test Shows Promise

  • Screening test measures DNA changes in three genes and detects occult blood.
  • Test shows 83 percent sensitivity for precancer with high-grade dysplasia.

ANAHEIM, CA. –  A new noninvasive test for colorectal cancer screening demonstrated high sensitivity for detecting colorectal cancer, in particular precancers that are most likely to develop into cancer, according to data presented at the 11th Annual AACR International Conference on Frontiers in Cancer Prevention Research, held here Oct. 16-19, 2012.

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