FDA Approves New Colon Cancer Screening Blood Test That Should Be Covered by Insurance: ‘It’s Going to Have a Huge Impact’

Health authorities have approved a new blood test for detecting colon cancer.

The FDA announced Monday that it has approved Shield, a blood test from Guardant Health in California.

While the test is not intended to replace colonoscopies (the gold standard for screening), doctors believe it could help curb the rising incidence of colorectal cancer in the U.S., particularly among young people.

The device, which currently retails for nearly $900, will likely be covered by most insurance plans, although it’s unclear when that coverage will take effect.

Guardant’s blood test, which currently retails for $895, is expected to be covered by most insurance plans following FDA approval

Dr. Sapna Syngal, director of strategic planning for prevention and early cancer detection at Dana-Farber Cancer Center in Boston, said NBC News: ‘The biggest problem with colon cancer at the moment is that a significant part of the population does not get screened.’

‘If this test ensures that more people get screened, it will have a huge impact.’

Guardant recommends that Shield be administered every three years, starting at age 45. This is the same age that colonoscopies should begin.

If Shield detects cancer DNA, a colonoscopy is still needed to locate the tumors.

Dr. Robert Smith, senior vice president of Early Cancer Detection Science at the American Cancer Society, told NBC News: “People need to understand that a positive Shield test requires a colonoscopy to confirm that you have an advanced lesion or colorectal cancer, or that the results were incorrect.”

‘Such a test is not complete if it is positive and you have not had a colonoscopy.’

The approval follows a March study that found Shield was 83 percent effective at detecting colorectal cancer, but the drug is best suited for detecting late-stage disease.

The study found that the test, which detects DNA released into the bloodstream from cancerous tumors, was only 13 percent effective at detecting early-stage disease.

According to the NCI, about one in four colorectal cancers is diagnosed at stage three or four, and fewer than 20 percent of patients with stage four survive the disease after five years.

The American Cancer Society estimates that more than 53,000 people will die from colon cancer this year, with the number being particularly high among Americans under 50.

Scientists still aren’t sure what exactly is causing the increase, but recent research suggests that a diet high in red meat, processed foods and sugar could be to blame.

Researchers at the University of Florida are recruiting young patients to determine whether energy drinks containing taurine can also cause colon cancer.

Dr. Arvind Dasari, an associate professor in the division of gastrointestinal and medical oncology at the University of Texas MD Anderson Cancer Center, told NBC News the approval was a “welcome development” but cautioned that the exact impact is still unclear.

‘We will have to wait and see what the impact will be on improving screening and reducing mortality.’