First Non-Invasive DNA Screening Test for Colorectal Cancer Approved by FDA

The U.S. FDA panel approved the first non-invasive DNA screening test called Cologaurd for colorectal cancer.

In a latest announcement, the U.S. Food and Drug Administration gave a nod to Cologuard - first stool-based colorectal screening test that easily identifies the presence of red blood cells and DNA mutation that reveal the presence of certain kinds of abnormal growth that may be cancers like colon cancer or precursors to cancer.

Colorectal cancer is the third most common type of cancer and the second leading cause of cancer-related death in the United States. It affects people aged 50 years and older, reports the Centers for Disease Control and Prevention (CCD). Colorectal cancer is effective in lowering illness and death related to colon cancer. CDC estimates that everyone aged 50 years and older has to undergo regular screening tests as recommended. With this, nearly 60 percent of the cancer deaths can be avoided.

This cancer occurs in colon or rectum. It starts as abnormal raised or flat tissue growths on the inner lining of the large intestine or rectum. The newly approved Cologuard uses stool sample and detects haemoglobin - a protein molecule that is a component of blood.

Cologuard successfully identifies the mutations linked with colorectal cancer in the DNA of the cell that is present in advanced adenomas as stools moves through large intestine and rectum. Those with positive test results are recommended to undergo diagnostic colonoscopy.

"This approval offers patients and physicians another option to screen for colorectal cancer," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health. "Fecal blood testing is a well-established screening tool and the clinical data showed that the test detected more cancers than a commonly used fecal occult test."

Using a clinical trial they tested the safety and effectiveness of Cologuard in 10,023 patients. They compared the performance of Cologuard to the decal immunochemical tests (FIT) -commonly used non-invasive screening test that detects blood in stool.

Cologuard successfully identified 92 percent of colorectal cancer and 42 percent of advanced adenomas when compared to FIT that detected 74 percent of the cancer and 24 percent advanced adenomas. It also successfully identified subjects negative for the cancer or advanced adenomas.

Cologuard is manufactured by Exact Sciences in Madison, Wisconsin.