Panel recommends blood test to detect colon cancer for FDA approval
A panel of U.S. Food and Drug Administration advisers on Thursday recommended approval for a new blood test to detect colon and rectal cancer despite concerns over the test's accuracy.
Blood Test for Colon Cancer Screening Secures FDA Panel's Blessing
"It's a good colon cancer screening test, but for later-stage colon cancer," said Karla Ballman, PhD, of the Mayo Clinic College of Medicine and Science in Rochester, Minnesota, who cast her votes in support of the test. "It's not as good in stage I, and definitely not good for advanced adenoma."
F.D.A. Panel Endorses Safety of Colon-Cancer Blood Test
The Guardant Health Shield test, one committee member said, “is better than nothing for patients who are getting nothing, but it is not better than a colonoscopy.”
FDA Panel Gives Nod to Blood Test for Colon Cancer
A U.S. Food and Drug Administration advisory panel on Thursday recommended the approval of a new blood test that can spot colon cancer. The panel voted 7-2 that the benefits outweighed the risks when using the Guardant Health's Shield test for colon cancer.
FDA Advisory Panel Supports Approval Of Guardant Health's Blood Test For Colorectal Cancer Screening
Thursday, the Molecular and Clinical Genetics Panel of FDA’s Medical Devices Advisory Committee recommended FDA approval of Guardant Health Inc’s (NASDAQ:GH) Shield blood test for colorectal cancer (CRC) screening.
Guardant Health Shares Rise 10% on Recommendation to Approve Blood Test for Cancer Screening
By Denny Jacob Guardant Health shares rose 10% in premarket trading after a regulatory advisory panel recommended for approval the company's blood test
U.S. FDA advisers back approval for Guardant's blood-based cancer test (May 23)
The FDA is expected to decide whether it would approve Shield later this year, Guardant Health said. If approved, Shield could become the second blood-based test for CRC screening
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