FDA Approves New Guardant360 Liquid CDx, the Largest FDA-Approved Liquid Biopsy Panel with a 100x Expanded Footprint

Key Terms

liquid biopsy medical

A liquid biopsy is a laboratory test that looks for tiny pieces of tumor or disease-related material — such as DNA, proteins, or cells — circulating in blood or other body fluids, allowing detection and monitoring without a surgical tissue sample. For investors, it matters because these tests can speed diagnosis, guide treatment choices, enable easier repeat testing, and create recurring revenue streams if adopted widely, affecting a medical company's growth and regulatory risk profile.

epigenomic medical

The epigenomic describes the pattern of chemical tags and markers across a cell’s DNA that control which genes are turned on or off, like sticky notes on a recipe book guiding what gets cooked. For investors, epigenomic changes are important because they can reveal new drug targets, diagnostics, or ways to predict and treat disease, affecting a biotech’s product pipeline, regulatory path, and long-term market value.

genomic medical

Relating to an organism’s genome — the complete set of DNA instructions that determine traits and biological functions — and to the study or use of that information. For investors, genomic technologies and data underpin diagnostics, targeted medicines, and personalized treatments, shaping potential market size, product timelines, and regulatory risk; think of it as reading an instruction manual to design precise medical products, which can speed innovation but also bring scientific and approval uncertainty.

companion diagnostic medical

A companion diagnostic is a medical test designed to identify which patients are likely to benefit from a specific drug or medical treatment, much like a key that shows whether a particular lock will open. For investors, these tests matter because they can increase a drug’s chances of approval and market uptake, create a separate revenue stream, and reduce commercial risk by matching treatments to the patients most likely to respond.

circulating tumor DNA (ctDNA) medical

Circulating tumor DNA (ctDNA) are tiny fragments of genetic material shed by cancer cells into the bloodstream, detectable with a blood test often called a liquid biopsy. For investors, ctDNA matters because it can enable earlier, less invasive detection of cancer, track how well treatments are working, and guide drug development and diagnostic products—factors that can drive demand, regulatory decisions, and company valuations in oncology-related markets.

precision oncology medical

Precision oncology uses detailed biological information from a patient’s tumor—like genetic changes or specific markers—to choose treatments most likely to work for that individual, much like tailoring a suit to a person’s measurements instead of selling one-size-fits-all clothing. It matters to investors because these targeted approaches can improve treatment success, support premium pricing and companion diagnostic tests, and shorten development and approval timelines, creating focused markets with both higher potential returns and specialized risks.

genotype medical

The genotype is an organism’s set of genes — its genetic makeup — that helps determine traits and how it responds to drugs or diseases. For investors, genotype matters because genetic differences can shape whether a therapy works, which patients are eligible, and how large or specialized a market will be; think of it like a product’s compatibility list that decides who can use it and how well it performs.

phenotype medical

Phenotype is the set of observable traits or measurable characteristics of an organism—such as appearance, behavior, disease signs, or lab measurements—produced by the interaction of its genes and the environment. For investors, phenotype matters because drugs, diagnostics, or agricultural products are judged by the tangible changes they produce; clear, consistent improvements in phenotype (think of a recipe’s final cake rather than the written recipe) help drive regulatory approval, market uptake, and revenue.

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• Guardant Health’s new FDA-approved liquid biopsy integrates genomic and epigenomic insights to provide a more complete, actionable view of cancer from a simple blood draw
• Approval strengthens Guardant’s leadership in comprehensive molecular profiling and advances a unified testing experience across liquid and tissue

PALO ALTO, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360® Liquid CDx, advancing blood-based comprehensive genomic testing by integrating genomic and epigenomic insights and helping clinicians make better-informed treatment selection decisions for patients with advanced cancer. Guardant360 Liquid CDx is the largest FDA-approved liquid biopsy panel, assessing a 100X wider genomic footprint than the previously approved Guardant360 CDx to deliver comprehensive tumor profiling results. The seven previously U.S. FDA-approved companion diagnostic indications for Guardant360 CDx transfer to the new test with the FDA approval of Guardant360 Liquid CDx.

Guardant360 Liquid CDx is powered by Guardant’s Smart Platform, which unlocks new dimensions of tumor biology by integrating genomic and epigenomic profiling from a single blood draw, providing a several-fold increase in sensitivity for circulating tumor DNA (ctDNA) detection from the previous Guardant360 CDx test and revealing clinically actionable insights that genomics alone may miss.

“Precision oncology is only as strong as the information clinicians have at the moment they need to make a decision,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “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. This approval moves us closer to a future where every physician has the right information at the right time to make the right decision.”

Guardant360 Liquid CDx builds on Guardant’s leadership pioneering the first FDA-approved comprehensive liquid biopsy. Building on this track record, the test also is the first liquid biopsy to simultaneously define both the genotype and key phenotype information¹, taking precision oncology to the next level. The updated test delivers fast results in as little as seven days, providing the information needed for clinical decisions regardless of tissue availability, line of therapy, or practice setting.

Guardant’s full product portfolio is now upgraded to its proprietary Smart Platform, an AI-enabled multiomic technology platform behind its next generation of cancer tests, supporting new clinical applications across the cancer care continuum from a single, scalable testing foundation.

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

About Guardant360® Liquid CDx

The largest FDA-approved liquid biopsy, Guardant360 Liquid CDx is the only FDA-approved liquid biopsy test integrating genomic and epigenomic data for comprehensive insights. Guardant360 Liquid CDx is approved as a companion diagnostic for multiple therapies in non-small cell lung cancer and colorectal cancer. It is also the only FDA-approved companion diagnostic for targeted therapy in advanced breast cancer patients with ESR1 mutations. The test is broadly covered by Medicare and commercial insurers, representing over 300 million lives.

Guardant Health Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

¹ Offered by professional service only. The professional service report is not reviewed nor approved by the FDA.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260520531436/en/

Investor Contact:
Zarak Khurshid
investors@guardanthealth.com

Media Contact:
Meaghan Smith
press@guardanthealth.com

Source: Guardant Health, Inc.