Guardant Health's Liquid Biopsy Test Receives FDA Approval for Expanded Use
Guardant Health Secures FDA Approval For Expanded Liquid Biopsy Test

Image: Benzinga
Guardant Health Inc. has received FDA approval for its Guardant360 Liquid CDx test, which enhances blood-based genomic profiling for advanced cancer patients. This updated test is now the largest FDA-approved liquid biopsy panel, offering a genomic footprint 100 times wider than its predecessor, and can deliver results in just seven days.
- 01The Guardant360 Liquid CDx test integrates genomic and epigenomic insights from a single blood sample.
- 02It is the first liquid biopsy capable of simultaneously identifying genotype and phenotype information.
- 03The test supports treatment decisions regardless of tissue availability, therapy line, or practice setting.
- 04Guardant Health's shares rose by 8.81% to $106.84 following the FDA approval.
- 05The updated test utilizes Guardant's proprietary Smart Platform, enhancing sensitivity in detecting circulating tumor DNA.
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The U.S. Food and Drug Administration (FDA) has approved Guardant Health Inc.'s Guardant360 Liquid CDx test, significantly expanding its capabilities in blood-based genomic profiling for patients with advanced cancer. This updated test is now recognized as the largest FDA-approved liquid biopsy panel, evaluating a genomic footprint that is 100 times wider than its predecessor, the Guardant360 CDx. The new test integrates both genomic and epigenomic insights from a single blood sample, providing clinicians with more comprehensive data to inform treatment decisions. Powered by Guardant's Smart Platform, an AI-enabled multiomic technology, the test enhances the sensitivity of circulating tumor DNA detection. Results can be delivered in as little as seven days, making it a valuable tool for treatment selection regardless of tissue availability or therapy line. Additionally, the Guardant360 Liquid CDx is the first liquid biopsy capable of identifying both genotype and key phenotype information simultaneously. Following the FDA's approval, Guardant Health's stock rose by 8.81%, reflecting positive market sentiment.
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