The U.S. Food and Drug Administration has approved a blood test for use in screening for colorectal cancer in average-risk adults aged 45 and older. The test’s manufacturer, Palo Alto, California-based biotechnology company Guardant Health, announced Monday that it is the first blood test approved by the FDA as a primary screening option for colorectal cancer and the first approved blood screening test for colorectal cancer to meet Medicare reimbursement requirements. For patients with private insurance plans, the cost of the test may vary depending on individual plan coverage. The list price of the test has not yet been announced. “This is a promising step toward developing a more convenient tool for early detection that can make colorectal cancer more easily treatable,” Dr. William M. Grady, a gastroenterologist at Fred Hutchinson Cancer Center, said in a statement released by Guardant Health on Monday. In the United States, colorectal cancer is the second leading cause of cancer deaths, and more than 53,000 people are expected to die from the disease this year, according to the American Cancer Society. However, about 70% of colorectal cancer deaths could be prevented through increased screening.The test, called SHIELD, is expected to be commercially available within the next week and will join other types of colon and rectal cancer screening methods, including colonoscopies and at-home stool tests, as options that health care providers can offer to patients. Some patients may find a simple blood test more convenient, but find a colonoscopy invasive or may be hesitant to do a stool test at home. “The test has the same accuracy in detecting colorectal cancer as stool tests used to detect cancer early, and it could provide an alternative for patients who may decline current screening tests,” Grady said in a news release. Current colorectal cancer screening options for average-risk individuals include stool tests done annually or every three years, traditional colonoscopies every 10 years, virtual colonoscopies every five years, or sigmoidoscopy, which uses a tube-like instrument called an endoscope to examine the lower part of the colon every five years. According to the National Colorectal Cancer Roundtable, it is estimated that more than one in three adults ages 50 to 75 are not getting screened as recommended. The U.S. Preventive Services Task Force recommends that people at average risk begin screening for colorectal cancer at age 45. “Persistent disparities in colorectal cancer screening rates indicate that existing screening options are not attractive to millions of people,” Dr. Daniel Chang, a gastroenterologist at Massachusetts General Hospital and professor of medicine at Harvard Medical School, said in a statement released by Guardant Health on Monday. “FDA approval of the Shield blood test is a major step forward and provides a compelling new solution to close this gap. This decision will help make screening tests more widely available,” Dr. Chang said. “More lives can be saved through improved screening rates and earlier detection of cancer.” In the United States, approximately 1 in 23 men and 1 in 25 women will be diagnosed with colorectal cancer in their lifetime. The Shield blood test was already available as a laboratory-developed test, or LDT, prior to FDA approval, but the FDA approval could make the test more widely available and broadly covered as another primary screening option. The current out-of-pocket price for the LDT version of the test is $895. In May, the Molecular and Clinical Genetics Panel of the FDA’s Medical Device Advisory Committee voted 8-1 that the Shield test is safe to use for people who meet the criteria for the test, voted 6-3 that the test is effective for people who meet the criteria, and voted 7-2 that the benefits of the test outweigh the risks. The Shield test works by detecting tumor DNA in blood samples, and doctors must order the test and kit for their patients. A study of nearly 8,000 people published in the New England Journal of Medicine in March found that the test had a sensitivity of about 83% and a specificity of 90%. Sensitivity refers to the test’s ability to accurately identify and designate people who have the disease as positive. Specificity refers to the ability to accurately designate people who do not have the disease as negative. In the study, about 83% of participants diagnosed with colorectal cancer by colonoscopy tested positive for the Shield test, and about 17% were false negatives. The test has a sensitivity of about 88% to detect stage I, II, or III colon cancer, but a lower sensitivity of about 13% to detect precancerous lesions. About 90% of study participants without advanced colon cancer or precancerous lesions tested negative for the blood test, and about 10% had false-positive test results. Separately, several research teams and companies are working on developing a simple blood test to screen for colon and rectal cancer. “There is an argument that point-of-care blood tests could significantly reduce the incidence of very advanced disease and save lives, even if they are unlikely to prevent disease,” said Robert Smith, senior vice president of early cancer detection science at the American Cancer Society. In May, blood tests cannot identify worrisome lesions or polyps in the colon or rectum, as colonoscopies can. Visual exams such as colonoscopies and sigmoidoscopies can identify and remove lesions or polyps that may progress to cancer, thus preventing cancer. “Most people would like to have the option of a blood test that is more accurate in terms of finding not just cancer but also precursor disease. But the thing about colon cancer screening is that people have different willingness to take one test or another,” Smith said. “We need to give people a choice.”
The U.S. Food and Drug Administration has approved a blood test for use in screening for colorectal cancer in average-risk adults aged 45 and older.
Guardant Health, the Palo Alto, California-based biotechnology company that makes the test, announced Monday that it is the first blood test approved by the FDA as a primary screening test for colon cancer and the first blood test approved for colon cancer that meets Medicare reimbursement requirements. For patients with private insurance plans, the cost of the test may vary depending on each plan’s coverage. The list price of the test has not yet been announced.
“This is a promising step toward developing more useful tools that may make it easier to detect and treat colorectal cancer earlier,” said Dr. William M. Grady, a gastroenterologist at Fred Hutchinson Cancer Center. Guardant Health said in a statement Monday..
Colorectal cancer is the second leading cause of cancer death in the United States, with more than 53,000 people expected to die from the disease this year. American Cancer Societybut, 70% of deaths from colorectal cancer It can be prevented by increasing testing.
The test, called SHIELD, is expected to be commercially available within the next week and will join other types of colon and rectal cancer screening options, such as colonoscopies and at-home stool tests, as options that health care providers can offer to patients. For some patients, a simple blood test may be more convenient, but a colonoscopy may feel invasive, or a at-home stool test may feel awkward.
“This test may detect colorectal cancer with similar accuracy to stool tests used for early cancer detection and provide an alternative for patients who may decline current testing options,” Grady said in a news release.
Current options for colon cancer screening for people at average risk include stool tests done annually or every three years, a traditional colonoscopy every 10 years, a virtual colonoscopy every five years, or a sigmoidoscopy procedure every five years, which uses a tube-like instrument called an endoscope to examine the lower part of the large intestine.
It is estimated that more than one in three adults between the ages of 50 and 75 do not get tested as recommended. National Colorectal Cancer RoundtableThe U.S. Preventive Services Task Force Colon cancer screening begins at age 45 For those at average risk.
“Persistent disparities in colorectal cancer screening rates suggest that existing screening options are unattractive for millions of people,” Dr. Daniel Chang, a gastroenterologist at Massachusetts General Hospital and professor of medicine at Harvard Medical School, said in a statement released Monday by Guardant Health.
“The FDA’s approval of the Shield blood test is a major step forward and offers a compelling new solution to fill this gap. This decision makes screening tests more widely available,” Chung said. “Increased screening rates and earlier cancer detection will save more lives.”
In the United States, about 1 in 23 men and 1 in 25 women Up to 1 million people will be diagnosed with colorectal cancer during their lifetime.
of Shield Blood Test The test was already available as a laboratory developed test (LDT) prior to FDA approval, but FDA approval will make the test more widely available and likely to be widely covered as another primary screening option. The current out-of-pocket price for the LDT version of the test is $895.
In May, the F.D.A. Molecular and Clinical Genetics Panel of the Medical Device Advisory Committee They voted 8 to 1 that shielding tests are safe for people who meet the criteria for testing, voted 6 to 3 that tests are effective for people who meet the criteria, and voted 7 to 2 that the benefits of testing outweigh the risks.
The Shield test works by detecting tumor DNA in a blood sample, and doctors must order the test and kit for their patients.
The test was found to have a sensitivity of about 83% and a specificity of about 90% in a study of nearly 8,000 people published in March. New England Journal of MedicineSensitivity refers to the ability of a test to accurately identify people who have the disease and call a positive result, while specificity refers to the ability of a test to accurately call a negative result in people who do not have the disease.
According to the study, among participants who were diagnosed with colorectal cancer through colonoscopy, about 83% had a positive result on the SHIELD test, while about 17% had a false negative result.
The test had a sensitivity of about 88% for detecting stages I, II, and III colorectal cancer, but a lower sensitivity of about 13% for detecting precancerous lesions.
About 90 percent of study participants without advanced colorectal cancer or precancerous lesions had negative blood tests, and about 10 percent had false-positive results.
Separately, several research teams and companies are working on developing simple blood tests to screen for colon and rectal cancer.
“The argument is that point-of-care blood tests, while unlikely to prevent disease, could actually significantly reduce the incidence of very advanced disease and save lives,” says Robert Smith, senior vice president of early cancer detection science at the American Cancer Society. I said in May.
Blood tests cannot identify worrisome lesions or polyps in the colon or rectum the way a colonoscopy can. Visual tests such as a colonoscopy or sigmoidoscopy can identify and remove lesions or polyps that may progress to cancer, thus preventing cancer.
“Most people would prefer a blood-based option that’s more accurate in terms of finding not only cancer but also precursor disease. But the thing about screening for colorectal cancer is that people have different willingness to get tested,” Smith said. “You have to give people the choice.”
