FDA approves new blood test to detect colon cancer

The Food and Drug Administration (FDA, in English) approved this Monday the use of a new type of blood test to detect the colon cancer in adults aged 45 years or older with average risk of suffering from this disease, the second cause of death from cancer in USA.

Biotechnology company Guardant Health said in a statement today that the blood test, known as Shield, has been approved for people aged 45 or older with an average risk of developing colon cancer.

While the blood test does not replace colonoscopies, it could lead to more patients undergoing screening because it requires less time and effort.

This is the first blood test approved by the FDA as a primary screening option for colorectal cancer, meaning health care providers in the United States, including the public health insurance for adults known as Medicare, can now offer the test.

The American Cancer Society estimates that more than 150,000 people will be diagnosed with this type of cancer by 2024 and the disease will be responsible for more than 53,000 deaths in the country.

More than three out of four people who die from this disease are not up to date with their screening tests.

When colon cancer is detected at an early stage before it has spread, the five-year relative survival rate is 91%. But in the United States, the detection rate is only about 59%, which is far below the National Colorectal Cancer Roundtable’s goal of 80% for eligible individuals.

More than one in three eligible Americans (more than 50 million people) do not undergo colorectal cancer screening, often because of the perception that other available options, such as colonoscopy or stool tests, are invasive, unpleasant or uncomfortable.according to a report cited by California-based Guardant Health.

Daniel Chung, a gastroenterologist at Massachusetts General Hospital and professor of medicine at Harvard Medical School, said in the statement that the approval of the Shield blood test “marks a major step forward, as it offers a compelling new solution to close this gap.”

“With higher screening rates and early detection of cancer, many more lives can be saved,” he added.

A clinical trial published in The New England Journal of Medicine last March found that Shield was 83% effective in identifying colorectal cancer, but it only detected 13% of the disease in its early stages.