Guardant Health Receives FDA Approval for Guardant360 CDx as Companion Diagnostic
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 22 2026
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Guardant Health announced that the U.S. Food and Drug Administration has approved Guardant360 CDx as a companion diagnostic to identify patients with BRAF V600E-mutant metastatic colorectal cancer who may benefit from treatment with Braftovi in combination with cetuximab and chemotherapy. The approval was supported by data from Pfizer's Phase 3 BREAKWATER trial. Guardant stated this is the first FDA-approved companion diagnostic for Guardant360 CDx in colorectal cancer.
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Analyst Views on GH
Wall Street analysts forecast GH stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for GH is 124.69 USD with a low forecast of 105.00 USD and a high forecast of 155.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
19 Analyst Rating
18 Buy
1 Hold
0 Sell
Strong Buy
Current: 109.730
Low
105.00
Averages
124.69
High
155.00
Current: 109.730
Low
105.00
Averages
124.69
High
155.00
About GH
Guardant Health, Inc. is a precision oncology company focused on guarding wellness and giving every person more time free from cancer. It provides critical insights into what drives disease through its advanced blood and tissue tests, real-world data, and artificial intelligence (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 helping doctors select the treatment for patients with advanced cancer. For patients with advanced-stage cancer, it has developed Guardant360 laboratory developed test (LDT), and Guardant360 CDx test, a comprehensive liquid biopsy test to provide tumor mutation profiling with solid tumors and to be used as a companion diagnostic in connection with non-small cell lung cancer (NSCLC), and breast cancer. It offers other tests, including Guardant360 Tissue test, Guardant Reveal blood test, Guardant360 Response blood test and others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Guardant Health Stock Soars Amid New Collaborations
- Stock Performance: Guardant Health's stock has surged over the past six months, currently priced at $110.48 with a market cap of $14 billion, reflecting strong market confidence in its future growth potential.
- Collaboration Agreement: The company has signed a multi-year collaboration with Merck to develop companion diagnostics and market new cancer therapies using Guardant's Infinity Smart program, further solidifying its leadership in precision oncology.
- Positive Cash Flow: In Q3 2025, Guardant's core oncology business achieved positive free cash flow ahead of schedule, with management expecting to maintain this trend throughout 2026 and beyond, indicating significant operational efficiency improvements.
- FDA Approval: Guardant360 CDx received FDA approval as a companion diagnostic for Pfizer's Braftovi, marking its first FDA certification in colorectal cancer, which, while not impacting Q4 results, lays a solid foundation for future growth.
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Guardant Health's Guardant360 CDx Approved by FDA as Companion Diagnostic for mCRC Treatment
- FDA Approval: Guardant Health's Guardant360 CDx has received FDA approval as a companion diagnostic for identifying patients with BRAFV600E-mutant metastatic colorectal cancer, marking a significant expansion in the company's precision medicine capabilities.
- Clinical Trial Support: The accelerated approval for Braftovi is backed by data from Pfizer's Phase 3 BREAKWATER trial, which demonstrated significant improvements in objective response rates and survival, likely boosting market demand for the associated therapies.
- Non-Invasive Testing Advantage: Guardant360 CDx is the first FDA-approved liquid biopsy that detects multiple genomic alterations through a simple blood draw, enhancing access to treatment for high-risk patients, particularly when tumor tissue samples are insufficient.
- Strong Financial Performance: Guardant Health anticipates revenues of $981 million in 2025, a 33% year-over-year increase, and analysts expect a slight improvement in earnings per share in the upcoming report, reflecting positive market sentiment regarding its growth prospects.
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