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Guardant Health Says Colorectal Cancer Detection Test Receives FDA Panel Recommendation
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Guardant Health Says Colorectal Cancer Detection Test Receives FDA Panel Recommendation
May 24, 2024 2:11 AM

04:57 AM EDT, 05/24/2024 (MT Newswires) -- Guardant Health ( GH ) said late Thursday a panel of the US Food and Drug Administration's Medical Devices Advisory Committee has recommended approval of the company's Shield blood test for colorectal cancer screening in adults who are at least 45 years old and at average risk for the disease.

Panel members voted favorably 8 to 1 on whether there was reasonable assurance that the test was safe, 6 to 3 in favor of its effectiveness, and 7 to 2 that its benefits outweigh its risks, the company said.

The oncology firm said the recommendation follows a premarket approval application for Shield and the results of a study in which it "demonstrated 83% sensitivity for the detection" of colorectal cancer, Guardant said.

The FDA is due to decide on Shield's approval later this year.

Shares of the company were temporarily halted Thursday ahead of the start of the panel's meeting.

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