Guardant Health Receives FDA Approval for Guardant360® CDx as Companion Diagnostic for BRAFTOVI® (encorafenib) Combination in Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer

• First FDA-approved CDx for Guardant360 CDx in colorectal cancer further expands its role in guiding targeted therapy across solid tumors
• Approval supported by data from Pfizer’s BREAKWATER trial demonstrating improved outcomes in BRAF V600E-mutant mCRC with encorafenib-based treatment

PALO ALTO, Calif.–(BUSINESS WIRE)–$GH–Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360® CDx as a companion diagnostic to identify patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) who may benefit from treatment with BRAFTOVI® (encorafenib) in combination with cetuximab and chemotherapy in accordance with the approved product labeling.

The accelerated approval was supported by data from Pfizer’s Phase 3 BREAKWATER trial, which evaluated encorafenib-based regimens in previously untreated patients with BRAF-mutated metastatic colorectal cancer mCRC. The study showed that treatment with encorafenib and cetuximab plus mFOLFOX6 chemotherapy significantly improved objective response rate, progression-free and overall survival compared with standard care, underscoring the importance of early genomic testing to guide targeted therapy.

Guardant360 CDx expands access to non-invasive genomic testing for this high-risk patient population. Using a simple blood draw to detect BRAF V600E and other clinically relevant genetic alterations, the test helps clinicians quickly identify patients eligible for FDA-approved treatments, enabling timely treatment decisions when tumor tissue is unavailable, insufficient, or when rapid initiation of therapy is clinically necessary.

“This latest approval highlights the growing impact of liquid biopsy across advanced cancer care and underscores the utility of Guardant360 CDx in enabling precision therapy selection for patients with diverse, hard-to-treat tumors including aggressive colorectal cancer,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “With multiple FDA-cleared companion diagnostic claims across lung and breast cancer, and now colorectal cancer, and the ability to comprehensively profile tumor genomics from a simple blood draw, Guardant360 CDx is helping clinicians match patients to the right targeted therapies faster and more effectively.”

Key highlights of the BREAKWATER trial include:

• Demonstrated significant improvement in overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) for patients treated with encorafenib plus cetuximab with mFOLFOX6 chemotherapy.
• Guardant360 CDx enabled rapid ctDNA analysis for treatment selection and resistance monitoring.
• The study supports the importance of early, comprehensive genomic profiling to improve outcomes in mCRC.

Colorectal cancer remains the second-leading cause of cancer-related deaths in the U.S., with BRAF V600E mutations present in approximately 8 to 10 percent of mCRC cases.¹ The mutation is a molecularly distinct and aggressive subtype of mCRC with poor prognosis and limited treatment options. Early identification of this mutation is critical to guiding patients to more effective, targeted therapies. Guardant360 CDx offers a convenient and accessible method for detecting this actionable biomarker, especially when tissue samples are unavailable or inadequate for testing.

This latest FDA approval for Guardant 360 CDx marks the 25^th companion diagnostic indication across multiple tumor types and builds on the platform’s increasing clinical utility and broad coverage by Medicare and commercial payers, representing more than 300 million covered lives.

About Guardant360® CDx

Guardant360 CDx is the first FDA-approved liquid biopsy for comprehensive genomic profiling. It detects multiple genomic alterations across all solid tumors and is approved as a companion diagnostic for therapies in non-small cell lung cancer, breast cancer, and now colorectal cancer. For more information, visit Guardant360 CDx.

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.

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, 2024 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 Mauri G, et al. Cancers, 2021.

Contacts

Investor Contact:
Zarak Khurshid

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Media Contact:
Meaghan Smith

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