(The Center Square) – The Food & Drug Administration has approved a blood test intended to detect colon cancer.
Colorectal cancer, once the fourth-leading cause of cancer deaths for people younger than 50, has leaped up the list, becoming the leading cause for men and ranking second for women, according to a study published earlier this year.
The blood test, called Shield, from company Guardant Health, Inc., is approved for screening adults ages 45 and older who are at average risk for the disease. The approval follows promising results from a clinical study of the blood test from earlier this year.
The study, published in the New England Journal of Medicine in March, found the test correctly detected colorectal cancer in 83% of people confirmed to have the disease, but not experiencing symptoms.
Dr. William Grady is a gastroenterologist and professor at the Fred Hutchinson Cancer Research Center and Digestive Health Center at UW Medical Center.
“This is a major breakthrough,” said Grady. “Now with FDA approval, CMS [Centers for Medicare and Medicaid] says if a blood test already met the performance characteristic, that they would reimburse that.”
The test is expected to be covered for CMS patients every three years, according to Grady, who hopes the private insurance market will soon follow.
“Typically, private insurers will also follow suit to reimburse,” he said. “The primary care providers will start ordering this and then my sense is the demand that will be coming, this will follow suit pretty quickly by private insurers.”
There is some question as to what private insurance companies will cover under the new recommendations from the FDA.
The Center Square reached out to the state Office of the Insurance Commissioner to see if it anticipates the newly approved test will be covered under private insurance plans.
Public Affairs Director Stephanie Marquis sent the following email: “It can take up to a year for an insurer to cover a test or Rx once it’s approved by the FDA. And it depends on the cost and projected usage of the item but generally a preventative test would not have a great impact on premiums.”
The out of pocket cost for the test is currently $895.
“They said [FDA] that CMS would reimburse for a person between 50 and 85 years of age, which doesn’t actually match with what the National Gastroenterology Association has set forth as guidelines for what is appropriate screening,” Grady observed.
“It’s between 45 and 75 that we recommend screening and if someone is older than that without high-risk features, they can stop doing screening,” he added.
Grady is concerned that with the colon screening blood test being approved, insurance companies may move away from colonoscopy, which is the gold standard for cancer screening.
“There’s been a lot of discussion among people who care about this about how this should be done,” he said. “When someone comes in do we automatically offer them a blood test, or should they be given the option of a colonoscopy?”
On the other hand, Grady says the approved blood test will encourage more people to screen earlier.
“Some people are going to say I was not going to get screened, but now there is this blood test so I’m going to go ahead and do that,” he said.
Colon cancer rates have gone up dramatically in recent years.
“What we’re seeing is more people under the age of 50 are getting colorectal cancer and traditionally, those people have not been screened,” Grady noted. “The big question that we’re all trying to get a handle on is why is this happening, and I wouldn’t be surprised if we start doing tests on people who are 40 and older, rather than 45.”
Weight gain and dietary choices might play a role.
“More people are overweight, and we know being overweight increases risk for a number of diseases like diabetes and a number of cancers,” Grady said. “Also a sedentary lifestyle and people are eating a lot of processed foods and not enough vegetables and all those foods may have changed our microbiomes.”
