By Jacqueline Howard | CNN
The U.S. Food and Drug Administration has approved a blood test to screen for colon cancer in adults aged 45 and older who’re at average risk.
The test's maker, Palo Alto-based biotechnology company Guardant Health, announced Monday that it’s the first blood test approved by the FDA as a primary screening option for colon cancer and that it’s the first approved blood screening test for colon cancer that meets the necessities for Medicare reimbursement. For patients with private medical insurance, the fee of the test may vary depending on individual insurance plan coverage. The list price for the test has not yet been announced.
“This is a promising step toward providing more convenient tools for early detection of colon cancer while making it easier to treat,” said Dr. William M. Grady, a gastroenterologist on the Fred Hutchinson Cancer Center. Guardant Health said in a press release on Monday.
In the United States, colon cancer is the second leading reason behind cancer deaths. More than 53,000 persons are expected to die from the disease this yr, in accordance with the American Cancer Society. But over 70% of deaths from colon cancer may be prevented by increased screening.
The test, called Shield, is predicted to hit the market next week and can be an option that healthcare providers can offer their patients alongside other methods of screening for colon and rectal cancer, including colonoscopies and residential stool tests. An easy blood test could also be more convenient for some patients, while colonoscopies may be invasive or home stool tests may be uncomfortable.
“The test, which has similar accuracy in detecting colon cancer as stool tests for early cancer detection, could provide an alternative for patients who would otherwise decline current screening options,” Grady said within the press release.
Current colon cancer screening options for people at average risk include a stool test yearly or every three years, a standard colonoscopy every 10 years, a virtual colonoscopy every five years, or a sigmoidoscopy every five years, which uses a tube-shaped instrument called an endoscope to look at the lower a part of the colon.
It is estimated that multiple in three adults aged 50 to 75 don’t attend preventive screenings as really helpful. National Roundtable on Colon CancerThe US Preventive Services Task Force recommends Screening for colon cancer begins at age 45 for individuals with average risk.
“The persistent gap in colorectal cancer screening rates shows that existing screening options are not attractive to millions of people,” said Dr. Daniel Chung, a gastroenterologist at Massachusetts General Hospital and professor of medication at Harvard Medical School, in a press release released Monday by Guardant Health.
“The FDA's approval of the Shield blood test is a tremendous step forward and offers a compelling new solution to fill this gap. This decision will help make screening tests more widely available,” Chung said. “With increased screening rates and early cancer detection, many more lives can be saved.”
In the United States, about 1 in 23 men and 1 in 25 women will develop colon cancer during their lifetime.
The Schild blood test was already available as a laboratory-developed test, or LDT, prior to FDA approval, however the agency's approval could make the test more widely available and supply broader coverage as one other primary screening option. The current self-pay price for the LDT version of the test is $895.
In May, the FDA published Panel on Molecular and Clinical Genetics of the Medical Devices Advisory Committee The authors voted 8 to 1 that the Shield test is protected in individuals who meet the standards for testing, 6 to three that the test is effective in individuals who meet the standards, and seven to 2 that the advantages of the test outweigh the risks.
The Shield test detects tumor DNA in blood samples and The doctor would need to order the test and kit for his patient.
In a study of just about 8,000 participants conducted in March New England Journal of Medicine. Sensitivity refers to the flexibility of a test to accurately discover diseased individuals and label them as positive. Specificity refers to the flexibility to accurately label diseased individuals as negative.
The study found that about 83% of participants diagnosed with colon cancer by colonoscopy tested positive for the disease using the Shield test, compared with about 17% who had a false negative result.
The test showed a sensitivity of about 88% in detecting stage I, II or III colon cancer and a lower sensitivity of about 13% in detecting precancerous changes.
About 90 percent of study participants without advanced colon cancer or precancerous changes had a negative blood test result, compared with about 10 percent who had a false positive test result.
In addition, several research teams and corporations are working on developing easy blood tests to detect colon and rectal cancer.
A blood test, unlike a colonoscopy, cannot discover worrisome lesions or polyps within the colon or rectum. Visual examinations reminiscent of colonoscopies or sigmoidoscopies can discover and take away lesions or polyps that might grow to be cancer, stopping the disease.
“Most people would like a blood test that was more accurate in detecting not just cancer but also precancerous lesions. But the most remarkable thing about colorectal cancer screening is that people's willingness to do one test or the other varies,” Smith said. “You have to give people the choice.”
The-CNN-Wire
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