FDA approves Exact Sciences’ Cologuard stool DNA colorectal cancer screening test

12 August 2014 (Last Updated August 12th, 2014 18:30)

The US Food and Drug Administration (FDA) has granted approval for US-based molecular diagnostics firm Exact Sciences' noninvasive, stool DNA colorectal cancer screening test Cologuard.

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The US Food and Drug Administration (FDA) has granted approval for US-based molecular diagnostics firm Exact Sciences' noninvasive, stool DNA colorectal cancer screening test Cologuard.

As the first noninvasive screening test for colorectal cancer, Cologuard analyses both stool DNA and blood biomarkers.

The test is designed to detect biomarkers from DNA in cancer, which is shed from the colon as part of the digestive process and blood released in the stool.

The company said that Cologuard can detect 92% of cancers and 69% of the most advanced precancerous polyps in average risk patients.

Available through healthcare providers, Cologuard provides people aged 50 and older at average risk for colorectal cancer with the ability to test cancer at their homes.

After receiving FDA approval, the company also secured a proposed coverage memorandum for Cologuard from the Centers for Medicare and Medicaid Services (CMS).

The company said that Cologuard is the first product to take part in the joint FDA and CMS parallel review pilot programme, where both the agencies simultaneously review medical devices to help reduce the time between FDA approval and Medicare coverage.

Following a public comment period, a final National Coverage Determination will be presented in October or November of 2014.

"The FDA approval of Cologuard represents a major achievement in Exact Sciences' mission to make a noninvasive, patient-friendly screening test for colorectal cancer available."

Colon Cancer Alliance CEO Eric Hargis said: "Colorectal cancer is highly preventable and following the recommended screening guidelines can lead to life-saving early detection.

"In more than 60% of all cases, colorectal cancer is not detected until its late stages, making treatment more challenging.

"New, patient-friendly screening options are desperately needed to prevent colorectal cancer or help identify it early, when it is most treatable.

"Given that more than half of colorectal cancer-related deaths could be avoided with regular screenings, having Cologuard as another option for people who have resisted getting a colonoscopy could result in many lives being saved and screening compliance rates to increase."

In the US, an estimated 23 million people between 50 and 75 are not getting screened as recommended, and as a result, colorectal cancer remains the second-leading cancer killer in the country, the company said.

Exact Sciences president, CEO and chairman Kevin Conroy said: "The FDA approval of Cologuard represents a major achievement in Exact Sciences' mission to make a noninvasive, patient-friendly screening test for colorectal cancer available.

"Cologuard addresses a critical need for a more convenient screening option for patients to aid in prevention and early detection."


Image: With Cologuard, patients can provide a sample in the privacy of their own home. Photo: courtesy of Exact Sciences.