10 months ago
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(NewsNation) — The U.S. Food and Drug Administration has approved a humor trial to observe colon cancer.
Guardant Health's humor test, known arsenic Shield, was approved for adults aged 45 years and older. This non-invasive screening trial detects alterations successful the humor associated with colorectal cancer. It's intended arsenic a screening trial for radical astatine mean hazard for the disease, not those astatine precocious risk, according to Guardant.
"The FDA support of the Shield trial is simply a important triumph for patients and an important milestone successful Guardant Health's ngo to conquer crab with data. Shield tin assistance amended colorectal crab screening rates truthful we tin observe much cancers astatine an aboriginal stage, erstwhile they are treatable," said AmirAli Talasaz, co-CEO of Guardant Health.
Shield has been disposable successful the U.S. arsenic a laboratory-developed trial since 2022 and is disposable for a self-pay terms of $895. It's expected to summation backstage and authorities security sum with FDA approval.
The trial looks for DNA fragments from tumor cells and precancerous growths. In a survey published successful March, the test caught 83% of the cancers but precise fewer of the precancerous growths recovered by colonoscopy, the golden modular for colon crab screening. The trial missed 17% of cancers, show that is connected par with stool-based tests.
Besides spotting tumors, colonoscopies tin forestall the illness by removing precancerous growths called polyps.
The yearly complaint of U.S. colon crab screening is astir 60%, beneath the 80% of age-eligible adults extremity acceptable by the American Cancer Society and different groups.
The Associated Press contributed to this report.
