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The US Food and Drug Administration has approved a blood test for colorectal cancer screening in average-risk adults age 45 and older.
The test's maker, Palo Alto, Calif.-based biotechnology company Guardant Health, announced Monday that this is the first blood test approved by the FDA as a primary screening option for colorectal cancer and the first blood test approved to meet Medicare reimbursement requirements for colorectal cancer. For patients with commercial insurance plans, the cost of the test may vary depending on the individual plan's coverage. The detailed cost of the test has not been announced yet.
“This is a promising step toward providing tools for early detection of colorectal cancer,” said Dr. William M. Grady, a gastroenterologist at the Fred Hutchinson Cancer Center. In a statement released by Guardian Health on Monday.
Colorectal cancer is the second leading cause of cancer death in the United States, and more than 53,000 people are expected to die from the disease this year, according to the report. American Cancer Society. But about 70% of colorectal cancer deaths It can be prevented by increasing screening.
The test, called Shield, is expected to be commercially available within the next week and will join other colon and rectal cancer screening methods — colonoscopies and home stool tests — that healthcare providers can offer their patients. A simple blood test may be more convenient for some patients, colonoscopies may feel invasive, or stool tests at home may be confusing.
“The test, with a similar level of accuracy in detecting colon cancer as stool tests used to detect early cancer, may provide an alternative for patients who reject current screening options,” Grady said in a news release.
Current options for colorectal cancer screening for people at average risk include annual or triennial stool-based screening. Traditional colonoscopy every 10 years; Virtual colonoscopy every five years; or a sigmoidoscopy procedure, which involves using a tube-like instrument called an endoscope to examine the lower part of the colon every five years.
It is estimated that more than 1 in 3 adults between the ages of 50 and 75 do not get screened as intended. National Colorectal Cancer Roundtable. The US Defense Services Task Force advises. Colorectal cancer screening begins at age 45. Average people at risk.
“The continuing gap in colorectal cancer screening rates shows that current screening options are not appealing to millions of people,” said Dr. Daniel Chung, a gastroenterologist at Massachusetts General Hospital and professor of medicine at Harvard Medical School. Guardian health.
“The FDA's approval of the Shield blood test represents a major leap forward, providing a compelling new solution to close this gap. This decision will help make screening tests more widely available,” Chung said. “With increased screening rates and early detection of cancer, many more lives can be saved.”
In the United States, about 1 in 23 men and 1 in 25 women They are diagnosed with colorectal cancer during their lifetime.
of Preventive blood test It was already available as a laboratory-developed test, or LDT, before FDA approval, but the agency's waiver could make the test widely available and widely covered as another primary screening option. The current self-pay price for the LDT test version is $895.
In May, the F.D.A Medical Devices Advisory Committee Molecular and Clinical Genetics Panel 8-1 voted that the shield test is safe for use by people who meet the test criteria, 6-3 that the test is effective for use by people who meet the criteria, and 7-2 that the benefits of the test outweigh the risks.
The Shield test works by detecting tumor DNA in blood samples, and a The doctor should order the test and kit for the patient.
The test was found to have 83% sensitivity and 90% specificity in a study of nearly 8,000 people published in March. New England Journal of Medicine. Sensitivity refers to the ability to accurately identify individuals with a disease, classifying it as positive. The difference refers to its ability to correctly identify people without the disease as negative.
The study found that 83 percent of participants diagnosed with colorectal cancer by colonoscopy reported having the disease on the shield test, while 17 percent had false negative results.
The test showed a sensitivity of about 88% for detecting stage I, II or III colorectal cancer and a low sensitivity, around 13%, for detecting precancerous lesions.
About 90% of study participants with advanced colorectal cancer or pre-cancer tested negative for the blood test, compared with 10% who had a false-positive result.
Separately, several research groups and companies have been working on developing simple blood tests to diagnose colon and rectal cancer.
“The point of contention is that point-of-care blood testing can significantly reduce the incidence of advanced disease and save lives, even though it has little potential to prevent disease,” said Robert Smith, senior vice president of early cancer screening at the American Cancer Society. He said in May.
A blood-based test cannot detect lesions or polyps in the colon or rectum like a colonoscopy can. Through imaging tests such as colonoscopy or sigmoidoscopy, a lesion or polyp at risk of becoming cancerous can be detected and removed, thereby preventing the disease.
“Many people would like to see a more accurate blood-based option for detecting primary lesions in addition to cancer. But the amazing thing about colorectal cancer screening is that people vary in their readiness to have one test or another,” Smith said. “You have to give people a choice. ”