Robin Foster – HealthDay News – A US Food and Drug Administration advisory panel on Thursday recommended approval of a new blood test that can detect the colon cancer.
The panel voted 7-2 that the benefits outweigh the risks when using the test Guardant Health Shield for colon cancer.
“The advisory committee’s strong support for Shield’s approval reinforces the crucial role a blood testing option can play in improving cancer rates.” detection [del cáncer de colon] for people with average risk,” said Guardant co-CEO, Amir Ali Talasazin a company press release announcing the panel’s vote.
“Despite the importance of detecting colorectal cancer early, there are notable barriers that may deter average-risk Americans from completing existing screening methods,” Talasaz added. “Shield effectively detects cancer in a early stage, when it is more treatable. Providing people with this blood test along with other non-invasive stool tests can increase the rate of colorectal screening and potentially reduce preventable deaths [por cáncer de colon]”.
If approved by the FDA, Shield would become the second colon cancer blood test in the United States: Epigenomics’ Epi proColon was approved in 2016.
Approximately 150,000 American patients are diagnosed with colon cancer each year, and it is the second leading cause of cancer deaths in the country, with more than 50,000 deaths each year, according to the American Cancer Society.
Currently, the colonoscopy It is the gold standard test for colon cancer, but adherence to it is low because it is invasive and preparation for the test is daunting. Other tests include fecal tests like Exact Sciences’ Cologuard, but blood-based tests are considered more convenient, NBC News reported.
Panelists were concerned that Guardant’s test was not as accurate as colonoscopy, especially because Shield detected only 13 percent of the precancerous tumors called advanced adenomas, NBC News reported. This issue was also raised by FDA staff in briefing documents.
Guardant’s application for approval was based on a study that showed the test detected 83% of colon cancers, according to FDA documents.
Shield “is better than nothing, but I don’t want to downplay the issue that this test is going to miss a lot of cancers,” Charity Morgan, a professor in the department of biostatistics at the University of Alabama and a member of the panel, said during the panel meeting. , reported NBC News.
The company expects the test will need to be repeated every one to three years, Guardant Health executive Victoria Raymond said during the meeting, but added that “colonoscopy should be the priority option” NBC News reported.
More information: The American Cancer Society has more information about colon cancer.
SOURCES: Guardant Health, news release, May 23, 2024; NBC News
* HealthDay Reporters ©The New York Times 2024
