The Food and Drug Administration on Monday approved Guardant Health’s blood test, called Shield, to screen for colon cancer. The test is not meant to exchange colonoscopies, but is generating enthusiasm amongst doctors who say it has the potential to spice up the dismal rate of screenings for the second-highest explanation for cancer death in america.
Shield has previously been available to doctors as a screening tool, at an out-of-pocket cost of $895. With the FDA approval, Medicare and personal insurance firms are far more more likely to cover the associated fee of the blood test, making it more widely accessible for patients.
Dr. Arvind Dasari, an associate professor within the department of gastrointestinal and medical oncology on the University of Texas MD Anderson Cancer Center, called the approval a “welcome development.”
But, he cautioned, “we’ll need to wait and see what the impact might be by way of improving screening and reducing the incidence of mortality.”
The American Cancer Society estimates that greater than 53,000 people will die of colorectal cancer this 12 months.
Research published in March showed Shield was 83% effective find colorectal cancers. It really works by detecting the DNA that cancerous tumors release into the bloodstream.
It’s handiest find later-stage cancers, when tumors release more of that DNA. The study found that Shield only detected 13% of earlier-stage polyps.
The test would must be given not less than every three years, starting at age 45 — the identical age it’s beneficial to start colorectal screening.
A positive test is not necessarily a diagnosis. If the outcomes indicate cancer is present, patients would still need a colonoscopy so doctors can see where tumors are situated and the way far they’ve progressed.
“People have to grasp that a positive Shield test requires a colonoscopy to verify that you could have a sophisticated lesion or colorectal cancer, or that the outcomes were false,” said Robert Smith, senior vp of Early Cancer Detection Science on the American Cancer Society. “A test like this shouldn’t be complete if it’s positive and you could have not had a colonoscopy.”
That is the second blood test to screen for colon cancer; Epigenomics’ Epi proColon was approved in 2016. However it’s rarely used, Smith said, due to concerns about its accuracy. It is also not covered by Medicare or private insurance.
Because the mid-Nineties there’s been a troubling rise in colon cancer in people younger than 55, with rates increase increasing by 1% to 2% per 12 months amongst that age group. At the identical time, cases and deaths amongst adults 60 and older have been declining, in response to the American Cancer Society.
“What breaks my heart is that it’s preventable,” said Dr. William Grady, a gastroenterologist at Fred Hutchinson Cancer Center in Seattle. “One in every of my biggest joys is once I’m doing colonoscopy and I can take out polyps” that, if left alone, would have progressed to cancer.
Indeed, colorectal cancer is considered one of the one cancers that will be prevented with screening, and colonoscopy is, by far, probably the most accurate technique to detect it. But screening rates are extraordinarily low. Fewer than 60% of people who find themselves eligible have had their beneficial screening.
“The most important problem with colon cancer without delay is that there is a significant a part of the population that is not getting screened,” said Dr. Sapna Syngal, director of strategic planning for prevention and early cancer detection on the Dana-Farber Cancer Center in Boston. “If this test increases the number of individuals getting screened, it will have a huge effect.”Â
Grady, who led the March study of the Shield test, said it’s often adults of their 40s and 50s who’re least more likely to be compliant with screening.
“These are people who find themselves employed, many have families, and so you could have all of those other life responsibilities that get in the best way of caring for themselves, he said.
Colonoscopy is time-consuming, forcing people to take not less than one break day work. There’s also a certain “ick” factor that many individuals find unpalatable. Throughout the procedure, doctors insert a tiny camera into the rectum to search for tumors or spots which will change into cancerous in the longer term.
That camera needs a transparent view of the colon. The day before the colonoscopy, patients need to take a robust dose of laxatives. That’s, they spend lots of time in the lavatory.
“Many individuals don’t love the messiness of coping with stool and plenty of people really don’t love the colonoscopy — mostly the prep,” said Electra Paskett, deputy director for population sciences and community outreach on the Ohio State University Comprehensive Cancer Center. “I feel a blood test could be ideal for many individuals.”
One other colon cancer screening method includes fecal occult blood tests that detect blood within the stool, which could be a warning sign of colon polyps or cancer. The FIT-DNA tests, reminiscent of Cologuard, are very effective at detecting cancer, but are less effective at detecting precancerous polyps.Â
John Gormly, 77, of Newport Beach, California, had avoided colonoscopy screening for years. When his doctor gave him the choice of the Shield blood test, he took it.
“He called me a day or so later and said, ‘I don’t love the outcomes in any respect. I will send you off to get a colonoscopy,'” Gormly recalled. “Seems I had stage 2 colon cancer.” Surgeons were in a position to remove the tumor completely.
“Thank God I had taken that blood test,” Gormly said. “I never felt anything, never knew anything was incorrect. Wanting that blood test, I do not understand how it could have turned out.”
