Guardant Health has secured US Food and Drug Administration (FDA) approval for its next generation liquid biopsy panel for informing cancer treatment decisions, combining genomic and epigenomic profiling to reveal further insight for cancer patients via a blood draw.
Guardant360 Liquid’s approval covers its application as a companion diagnostic (CDx) for multiple therapies in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), and for targeted therapy in advanced breast cancer patients with oestrogen receptor 1 (ESR1) mutations. The seven indications that its previous iteration, Guardant360 CDx, held transfer over to the new panel.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
According to Guardant, Guardant360 Liquid CDx’s integration of genomic and epigenomic insights means the panel can assess a much wider genomic footprint than the company’s previously approved Guardant360 diagnostic.
The test is also the first liquid biopsy to simultaneously define genotype and key phenotype information, Guardant stated, with the updated test delivering results within seven days, regardless of tissue availability, line of therapy, or practice setting.
Guardant’s chairman and co-CEO Helmy Eltoukhy said: “With FDA approval of the new Guardant360 Liquid CDx, cancer care enters a new era: one where genomics, epigenomics, advanced AI, and learnings from more than one million patients tested converge to deliver a more complete, actionable view of cancer from just a blood draw.”
A report by GlobalData forecasts that the overall diagnostics market in oncology will reach a valuation of $3.1bn in 2030.
Guardant360 Liquid marketing authorisation will likely fuel the California-based company’s ambitious growth aims in 2026. In 2025, Guardant achieved revenue of $982m, representing 33% year-over-year (YoY) growth from $739m in 2024. The company outlined in February that it expects 2026 revenue growth between $1.25bn and $1.28bn, indicative of a 27%-30% rise YoY.
