Guardant Health Announces Multi-Year Strategic Collaboration Agreement with Merck to Develop Companion Diagnostics and Commercialize New Cancer Therapies Using Guardant Infinity Smart Platform

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.

tissue biopsy medical

A tissue biopsy is a medical procedure that removes a small sample of cells or tissue from the body so doctors and labs can examine it under a microscope or run tests. For investors, biopsies matter because their results drive clinical decisions, confirm diagnoses, and are often required to prove a drug or diagnostic test works, which can affect trial outcomes, regulatory approval, and demand for related medical products — like taking a sample to verify whether a treatment hits its target.

companion diagnostics medical

A companion diagnostic is a medical test used alongside a specific drug or therapy to identify which patients are likely to benefit from it or may face safety risks. Think of it as a tailored matchmaker that tells doctors whether a particular treatment is a good fit for an individual. For investors, these tests matter because they can shape a drug’s approved use, speed and cost of development, patient uptake, reimbursement, and the commercial value of both the therapy and the diagnostic.

clinical trials medical

Clinical trials are carefully controlled studies that test whether a new drug, device or treatment is safe and effective in people, moving through successive stages that increase the number of participants and the rigor of testing. Investors care because trial outcomes determine whether a product can be approved and sold, shaping a company’s future revenue, valuation and risk profile—think of it as proof-of-concept testing that decides if a prototype becomes a market-ready product.

biomarkers medical

Biomarkers are measurable indicators found in the body, such as substances in blood or tissues, that reveal information about health or disease. For investors, they can signal how well a medical treatment is working or whether a disease is developing, helping to assess the potential success or risks of healthcare companies or innovations. Think of biomarkers as biological signals that provide clues about a person’s health status.

Multi-year global collaboration will utilize Guardant liquid biopsy portfolio for the development of companion diagnostics for drug approvals

PALO ALTO, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced a multi-year collaboration with Merck, known as MSD outside the United States and Canada, to support the development and commercialization of Merck’s oncology portfolio using the Guardant Infinity™ Smart platform.

Under the multi-year collaboration agreement, Guardant and Merck aim to:

• Use Guardant’s portfolio of liquid and tissue biopsy tests as clinical trial enrolling assays in Merck’s global clinical studies,
• Evaluate opportunities to develop novel therapies using Guardant liquid biopsy tests as a companion diagnostic, and
• Partner for global commercialization of drugs and companion diagnostics including in US, Asia-Pacific, UK and EU markets.

“This strategic collaboration allows us to bring the power of the Infinity Smart platform to some of the most important oncology programs in development today,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “As biomarkers become more central to therapy selection, our goal is to ensure that every trial has the molecular clarity needed to reach the right patients. This collaboration strengthens our shared commitment to rigor, scale, and faster development of life-changing cancer therapies.”

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.

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, 2024, and any current and periodic reports filed with or furnished to the Securities and Exchange Commission thereafter. 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.

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Investor Contact:

Zarak Khurshid

investors@guardanthealth.com

Media Contact:

Meaghan Smith

press@guardanthealth.com

Source: Guardant Health, Inc.