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BioWorld - Tuesday, July 7, 2026
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Home » FDA gives thumbs up to first liquid biopsy NGS CDx test
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FDA gives thumbs up to first liquid biopsy NGS CDx test

Aug. 10, 2020
By Liz Hollis
The U.S. FDA revealed good news for Guardant Health Inc. Specifically, the agency has given a thumbs up for Guardant360 CDx for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm. The Redwood City, Calif.-based company noted that this marked the first approval to combine next-generation sequencing (NGS) and liquid biopsy in one diagnostic test to guide treatment decisions. The assay previously was granted a breakthrough device designation.
Medical technology Regulatory Diagnostics Liquid biopsy Cancer FDA

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