On Thursday, consultants to the U.S. Food and Drug Administration suggested authorizing Guardant Health's blood test for distinguishing colon and rectal cancer.
US FDA Recommended Approval of Guardant Health's Blood Test
The panel decided on seven to two, concluding that the advantages of the Shield test dominate the dangers for colorectal cancer detection.
If allowed, Shield would become the next blood-based test for colon cancer in the U.S., after Epigenomics' Epi proColon, which was authorized in 2016.
Each year, about 150,000 people in the U.S. are diagnosed with colon or rectal cancer, making it the next popular root of cancer demises in the country, with over 50,000 deaths yearly, according to the FDA.
Currently, colonoscopy is recognized as the gold standard for colon cancer screening, but it has small adherence rates due to its intrusive nature. Other tests include stool-based tests, like Exact Sciences' Cologuard, but blood-based tests are seen as more appropriate. This preference was noted by FDA staff reviewers in documents released on Tuesday.
Guardant's Shield application was based on a study showing the test detected 83% of colorectal cancers, compared to Exact's Cologuard, which has a 92.3% sensitivity rate, as per FDA documents.
"Shield is better than nothing, but it's important to acknowledge that this test will miss many cancers," said Charity Morgan, a panel member and professor in the Department of Biostatistics at the University of Alabama.
Guardant Health executive Victoria Raymond mentioned at the meeting that the test might need to be repeated every one to three years but emphasized that "colonoscopy should remain the prioritized option."
Guardant Health's Blood Test Could be Available Soon
To screen for colon and rectal cancers, many people undergo colonoscopies, which are intrusive and need anesthesia, or use at-home stool tests, which are more appropriate but can be inconvenient.
A simpler blood test might soon become available.
Guardant Health, a biotechnology company in Palo Alto, California, has applied for FDA authorization for Shield, a blood test for early colorectal cancer discovery. The FDA's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee currently mentioned the test's data.
The panel voted 8-1 that the Shield test is harmless, 6-3 that it is efficient, and 7-2 that its advantages dominate the dangers. If certified, Shield would be the first blood-based colorectal cancer screening test worthy of Medicare reimbursement, according to Dr. Craig Eagle, Guardant Health's chief medical officer.
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Current screening choices for those at average danger include stool-based tests, colonoscopies, virtual colonoscopies, and sigmoidoscopies.
The Shield blood test is already accessible as a laboratory-developed test, but FDA authorization could make it more broadly accessible and covered as a main screening choice. It would integrate existing procedures, probably expanding the number of people who complete suggested screenings.
Blood-Based Tests Could Reduce Advanced Diseases and Save Live
Robert Smith of the American Cancer Society noted that blood-based tests could reduce advanced disease incidence and save lives, though they can't detect precancerous lesions or polyps like colonoscopies. People vary in their readiness to do one test or another, so offering a choice is essential.
The Shield test targets those 45 or older at average risk. High-risk people wouldn't use it, and those with irregular results would be referred for a colonoscopy. Since its lab-developed version started in May 2022, over 20,000 people have used Shield, with more than 90% completing the test.
FDA advisers were divided on the test's efficiency. Some panel members felt it met the criteria for detecting colorectal cancer, while others were concerned about its limited sensitivity for stage I cancer and precancerous lesions.
The Shield test works by discovering tumor DNA in blood samples, ordered by a physician. Research in the New England Journal of Medicine found the test had about 83% sensitivity and 90% specificity. It discovered around 83% of colorectal cancers but had restricted awareness of precancerous lesions.
Many qualified people skip screenings due to displeasure with stool-based tests and anxiety about colonoscopy exams. FDA authorization of a blood test like Shield could heighten screening rates and lessen cancer deaths.
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