The U.S. Food and Drug Administration (FDA) on Wednesday approved Guardant Health Inc.’s (NASDAQ:GH) Guardant360 Liquid CDx test, expanding the company's blood-based comprehensive genomic profiling capabilities for patients with advanced cancer.
The approval also transfers the seven previously approved companion diagnostic indications from Guardant360 CDx to the updated test.
The cancer testing company said Guardant360 Liquid CDx is now the largest FDA-approved liquid biopsy panel and evaluates a genomic footprint that is 100 times wider than the earlier Guardant360 CDx test.
The test combines genomic and epigenomic insights from a single blood sample to help clinicians make more informed treatment decisions.
New Platform Integrates Genomic And Epigenomic Insights
Guardant said the updated test is powered by its proprietary Smart Platform, an AI-enabled multiomic technology platform designed to improve circulating tumor DNA detection sensitivity compared with the previous Guardant360 CDx test.
According to the company, the platform integrates genomic and epigenomic profiling from one blood draw, helping identify clinically actionable information that may not be detected through genomics alone.
Faster Turnaround Time And Expanded Clinical Utility
Guardant said the updated liquid biopsy test can deliver results in as little as seven days. The company noted the test is designed to support treatment selection decisions regardless of tissue availability, therapy line, or practice setting.
The company also stated that Guardant360 Liquid CDx is the first liquid biopsy capable of simultaneously identifying genotype and key phenotype information.
Guardant added that its full oncology testing portfolio has now transitioned to the Smart Platform, which supports multiple cancer care applications across the treatment continuum using a single scalable testing infrastructure.
Price Action
Guardant Health shares were up 8.81% at $106.84 at the time of publication on Wednesday, according to Benzinga Pro.
Over the past month, GH has gained about 10.6% versus a 4.3% rise in the S&P 500 and is down roughly 2% year-to-date compared to the index’s 7.8% gain.
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