Guardant Health Announces Multi-Year Strategic Collaboration with Nuvalent to Develop Companion Diagnostics and Support Potential Commercialization of Targeted Cancer Therapies Using the Guardant Infinity™ 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.

cdx medical

A CDx (companion diagnostic) is a medical test that identifies which patients are likely to benefit from, or be harmed by, a specific prescription drug. Think of it like a key that tells doctors which lock (patient) matches a particular medicine, enabling more precise treatment choices; for investors, CDx tests can be crucial because regulatory approval and commercial uptake of a therapy often depend on the availability and performance of its companion diagnostic, affecting a drug’s market size and revenue timing.

biomarker medical

A biomarker is a measurable indicator found in the body, such as in blood or tissues, that provides information about health, disease, or how the body responds to treatment. For investors, biomarkers can signal the potential success or risk of medical products or therapies, influencing the value of related companies and industry trends. They act like signals or clues that help assess the progress of medical advancements and their market impact.

clinical-stage biopharmaceutical medical

A clinical-stage biopharmaceutical is a company that is developing medicines or biological treatments that are currently being tested in people in clinical trials to assess safety and effectiveness. For investors it signals a higher-risk, higher-reward profile: progress through human testing and regulatory milestones can sharply increase value if results are positive, while failed trials can wipe out expected future revenue — like a prototype that must prove it works before it can be sold widely.

kinase targets medical

Kinase targets are specific enzymes in cells that act like on/off switches for processes such as growth, division, and signaling; drugs designed against these enzymes aim to change those switches to slow or stop disease. For investors, kinase targets matter because successful drugs can become major revenue drivers, but they also carry scientific and regulatory risk — think of them as high-reward light switches that can be hard to flip reliably across patients.

regulatory approvals regulatory

Regulatory approvals are official permissions from government agencies that a company needs before launching a new product, service, or business activity. They matter because without this approval, the company might not be allowed to operate legally or sell its products, similar to how a driver needs a license to legally drive a car.

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• Multi-year global collaboration will leverage Guardant’s tissue and liquid biopsy portfolio to support clinical development and companion diagnostic strategies

PALO ALTO, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced a multi-year strategic collaboration with Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, to support the development and potential commercialization of Nuvalent’s oncology pipeline using the tissue and liquid offerings of the Guardant Infinity™ platform.

The collaboration reflects the growing importance of precision diagnostics in oncology drug development, where biomarker-driven approaches are increasingly essential for identifying appropriate patient populations, improving trial efficiency, and supporting regulatory approvals.

As key components of the collaboration, Guardant Health and Nuvalent plan to:

• Utilize Guardant’s portfolio of tissue and liquid biopsy tests to support certain Nuvalent global clinical studies;
• Evaluate opportunities to develop Guardant tissue and/or liquid biopsy assays as companion diagnostics (CDx) to support potential regulatory approvals of Nuvalent’s current investigational candidates; and,
• Collaborate on the global commercialization of Nuvalent’s product candidates, if approved, and Guardant companion diagnostics across major global key markets.

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 Nuvalent

Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we develop innovative small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses. Nuvalent is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs.

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, and the potential of Nuvalent’s pipeline programs, including potential regulatory approvals and commercialization of its product candidates, 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 or Nuvalent’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 their respective Annual Reports on Form 10-K for the year ended December 31, 2025, 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 and Nuvalent as of the date hereof, and Guardant Health and Nuvalent disclaim any obligation to update any forward-looking statements provided to reflect any change in their 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260430014027/en/

Investor Contact:
Zarak Khurshid
investors@guardanthealth.com

Media Contact:
Meaghan Smith
press@guardanthealth.com

Source: Guardant Health, Inc.