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The tissue-free Guardant Reveal test uses a blood sample, in contrast to tumor-informed approaches to MRD testing, which require a healthcare provider to obtain a physical tissue specimen of the ...
Guardant Health said the test would be the "first and only comprehensive biopsy-free cancer test available". [7] In 2016, the company announced clinical trial results demonstrating the test "detected disease-associated genetic mutations that were also present in 94% to 100% of the solid tissues extracted from the study's subjects". [8]
Guardant's test, known as Shield, has been available in the U.S. since 2022 for use by laboratories, for a self-pay price of $895, but is not covered under Medicare.
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Guardant's application for Shield was based on a study that showed the test detected 83% of colorectal cancers, while Exact's Cologuard had 92.3% sensitivity rate, according to the FDA's documents.
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