Screening for secondary causes Cancer deaths It just got a little easier.
The U.S. Food and Drug Administration (FDA) Colorectal cancer (CRC).
Shield, manufactured by California-based Guardant Health, is the first approved blood test recognized as the primary test for the disease and meets Medicare coverage requirements, according to the company.
What is colorectal cancer? Signs, symptoms, risks and more – a global health concern
The FDA approval, announced Tuesday, was a major Clinical Trials This included 20,000 average-risk adults and found that Shield had a sensitivity of 83% for detecting CRC.
These findings were published in March in the New England Journal of Medicine.
Shield, manufactured by California-based Guardant Health, is the first approved blood test recognized as the primary test for the disease and meets Medicare coverage requirements, according to the company. (Guardant Health)
Approved blood tests include EpiGenomics’ Epi-Procolon, but it is a second-line screening option and can only be administered to patients who have been offered a first-line option and have a history of not completing CRC screening, according to Guardant Health spokesman Michael Weist.
Dr. Robert Smith, senior vice president of early cancer detection science at the American Cancer Society in Atlanta, confirmed that SHIELD is the only blood test currently available. Colon cancer screening.
Tragic cancer death prompts New York tech entrepreneur to address ‘urgent medical need’
“The test compares favorably with other colorectal cancer screening tests, including colonoscopy, CT colonography and stool tests,” Smith, who is not affiliated with Guardant, told Fox News Digital.
“This will make the test more attractive to people who have never been tested before or who have not been tested recently,” he added.
The FDA’s approval was based on the results of a large clinical trial of 20,000 average-risk adults, which found that SHIELD was 83% sensitive in detecting colorectal cancer. (Guardant Health)
The main advantage of blood tests is that they can be performed during a routine medical examination. Doctor’s appointment There’s no preparation required or needing to take a day off work.
“This test has the potential to detect colorectal cancer in people who do not follow screening recommendations, who are asymptomatic, and who are willing to undergo the test based on preference, convenience, or both,” Smith said.
“It’s easier and takes less time than a colonoscopy.”
According to Dr. Shuji Ogino, director of the Molecular Pathology Epidemiology Program at Massachusetts General Hospital and Brigham and Women’s Hospital in Boston, SHIELD has “demonstrated reasonable sensitivity and specificity compared with other blood and stool tests.”
“It’s easier and takes less time than a colonoscopy,” Ogino, who is not affiliated with Guardant, told Fox News Digital.
Risks and limitations
ACS’s Smith said the risks of shielded testing haven’t been studied in regular-user populations, but the risks are likely minimal.
“But the shield test, Colorectal cancer “Detecting and removing precursor lesions (polyps) provides a significant benefit of routine screening with the currently recommended tests,” Smith warned.
The Shield blood test is manufactured by Guardant Health, based in Redwood City, California. (Guardant Health)
This downside will be offset by many of those who haven’t been tested choosing to get tested, he noted.
“The Shield blood test is less sensitive than the Cologuard stool test for detecting colorectal cancer,” Steven Grabelski, MD, a hematologist and medical oncologist at Boca Raton Regional Hospital’s Eugene M. & Christine E. Lin Cancer Institute, told Fox News Digital.
The test is only intended for people at standard risk for colorectal cancer and excludes patients with a family or personal history of colorectal cancer. Inflammatory bowel disease“It’s a very good test,” added Gravelcy, who was also not involved in the test’s development.
Early detection is key
Compliance rate for colorectal cancer Cancer screening That rate is just 59%, well below the National Colorectal Cancer Roundtable’s target of 80% for eligible individuals, Weist said.
The test is expected to be commercially available by this fall.
“More than one in three Americans who are eligible – more than 50 million people – are not being tested for colorectal cancer, often due to the perception that other options, such as colonoscopy and stool-based tests, are invasive, uncomfortable or inconvenient,” he said.
Click here to get the FOX News app
If colon cancer is detected early, the relative survival rate is 91%, but if the cancer has spread to distant parts of the body, it is just 14%.
“Early detection is key,” Weist says, “and the most effective screening test is one that’s actually done.”
Click here to sign up for our Health Newsletter
He told Fox News Digital that the Shield test is indicated for colon cancer screening in people aged 45 and over, who are at average risk of colon cancer.
The test is expected to be commercially available by this fall.
The Shield test is indicated for bowel cancer screening in people aged 45 and over who are at average risk of bowel cancer. (Guardant Health)
Patients interested in shield testing should discuss the benefits and limitations with their doctor. medical professionals; medical institutions Smith also recommends checking whether your insurance will cover it before making a choice.
“It is important to recognize that even if a colorectal cancer screening test is positive, the test is not complete until a patient has a colonoscopy,” Smith noted.
For more health related articles, Fox News
“If you have a positive colon cancer screening test other than a colonoscopy, you should definitely get a colonoscopy.”
