Guardant Health (GH) Receives FDA Approval for Guardant360 CDx Diagnostic to Enhance Colorectal Cancer Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 22 2026
0mins
Should l Buy GH?
Source: seekingalpha
- FDA Approval: The US FDA has approved Guardant Health's Guardant360 CDx companion diagnostic, which determines which patients with BRAF V600E-mutant metastatic colorectal cancer could benefit from Pfizer's Braftovi (encorafenib), providing more precise treatment options for patients.
- Blood Test Advantage: Guardant360 CDx utilizes a small blood sample to detect genetic mutations, enhancing testing convenience and accelerating treatment decisions for patients, thereby improving survival rates and quality of life.
- Broad Market Potential: With the increasing demand for personalized medicine among colorectal cancer patients, this new diagnostic is expected to drive revenue growth for Guardant Health in the future and solidify its market position in precision medicine.
- Optimistic Performance Outlook: Guardant Health's revenue guidance for Q4 and FY25 exceeds market expectations, indicating strong performance in the healthcare services sector and further boosting investor confidence in its future growth.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy GH?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on GH
Wall Street analysts forecast GH stock price to rise
19 Analyst Rating
18 Buy
1 Hold
0 Sell
Strong Buy
Current: 102.760
Low
105.00
Averages
124.69
High
155.00
Current: 102.760
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 Launches Colorectal Cancer Screening Grant Program
- Grant Program Launch: Guardant Health has announced the initiation of its Community Colorectal Cancer Screening Grant Program, aimed at supporting community organizations in expanding screening access during March's Colorectal Cancer Awareness Month, with up to 100 Shield tests provided per selected organization to enhance screening participation.
- No-Cost Testing: All Shield tests will be provided at no cost to patients and participating organizations, a move that not only alleviates financial burdens but also promotes health equity by removing barriers to screening in underserved and underscreened communities.
- Innovative Screening Tool: The Shield test is the first blood-based screening option for colorectal cancer approved by the FDA, intended for adults aged 45 and older at average risk, offering a more convenient screening alternative designed to increase acceptance and participation rates.
- Application Deadline: Interested organizations must submit their applications by February 17, 2026, with approval notifications sent via email on February 20, reflecting the company's commitment to supporting community health advocacy and outreach efforts.
See More
Guardant Health Launches Colorectal Cancer Screening Grant Program
- Grant Program Launch: Guardant Health has announced the launch of its Community Colorectal Cancer Screening Grant Program, aimed at supporting community organizations in expanding screening access during March's Colorectal Cancer Awareness Month, with up to 100 Shield tests provided per selected organization to enhance screening participation.
- No-Cost Screening: All Shield tests will be provided at no cost to patients and participating organizations, aiming to eliminate financial barriers, particularly in underserved and underscreened communities, reflecting the company's commitment to improving access to screening.
- Innovative Screening Tool: The Shield test is the first FDA-approved non-invasive blood-based screening tool designed for individuals aged 45 and older at average risk, offering a more convenient screening option to increase screening rates and reduce colorectal cancer-related mortality.
- Application Deadline: Interested organizations must submit their applications by midnight PST on February 17, 2026, with approval notifications sent via email on February 20, 2026, encouraging groups with strong community and health outreach capabilities to apply.
See More
AI Drives Transformation in Genomics and Biological Manufacturing
- Genomics Advancement: Illumina secures U.S. Medicare reimbursement for its TruSight™ Oncology Comprehensive test, expected to significantly enhance the generation of clinically relevant genomic data, thereby advancing routine genomic profiling in cancer care.
- Liquid Biopsy Expansion: Guardant Health expands the availability of its Shield™ colorectal cancer screening test to U.S. military personnel and their families, enhancing the foundational data generation for precision medicine through ctDNA analysis.
- Drug Discovery Innovation: Recursion Pharmaceuticals leverages AI and machine learning to accelerate drug discovery, emphasizing platform scalability to reduce development time and costs, while attracting institutional interest from firms like ARK Investment Management.
- Spider Silk Production Plan: Kraig Biocraft Laboratories plans large-scale deployment of its transgenic silkworm platform in 2026, aiming to achieve a production capacity of 10 metric tons of recombinant spider silk per month by May, potentially opening new markets for high-performance materials.
See More
GUARDANT HEALTH INC: UBS Increases Price Target from $110 to $175
- Price Increase Announcement: Cub's target price has been raised to $175 from the previous $110.
- Market Impact: This adjustment reflects a significant change in market expectations and valuation for Cub.
See More
Guardant Health's Optimistic Future Outlook
- Positive Financial Performance: Guardant Health achieved positive free cash flow in Q3 2025, one quarter ahead of its goal, indicating strong growth potential in its core oncology business, with expectations to maintain positive cash flow throughout 2026 and beyond, thereby boosting investor confidence.
- Strategic Collaboration Expansion: The company 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 market position in precision oncology.
- FDA Approval Milestone: Guardant360 CDx received FDA approval as a companion diagnostic for Pfizer's Braftovi and Eli Lilly's Erbitux in combination chemotherapy, marking its first FDA approval in colorectal cancer, enhancing the company's competitive edge in the market.
- Optimistic Market Outlook: Although the fourth-quarter financial results for 2025 have yet to be announced, investors maintain an optimistic view of Guardant Health's future, believing that the upcoming update could serve as a catalyst for stock price appreciation, although caution is advised against rushing into purchases in the short term.
See More
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.
See More
Guardant Health Launches Colorectal Cancer Screening Grant Program
- Grant Program Launch: Guardant Health has announced the initiation of its Community Colorectal Cancer Screening Grant Program, aimed at supporting community organizations in expanding screening access during March's Colorectal Cancer Awareness Month, with up to 100 Shield tests provided per selected organization to enhance screening participation.
- No-Cost Testing: All Shield tests will be provided at no cost to patients and participating organizations, a move that not only alleviates financial burdens but also promotes health equity by removing barriers to screening in underserved and underscreened communities.
- Innovative Screening Tool: The Shield test is the first blood-based screening option for colorectal cancer approved by the FDA, intended for adults aged 45 and older at average risk, offering a more convenient screening alternative designed to increase acceptance and participation rates.
- Application Deadline: Interested organizations must submit their applications by February 17, 2026, with approval notifications sent via email on February 20, reflecting the company's commitment to supporting community health advocacy and outreach efforts.
See More
Guardant Health Launches Colorectal Cancer Screening Grant Program
- Grant Program Launch: Guardant Health has announced the launch of its Community Colorectal Cancer Screening Grant Program, aimed at supporting community organizations in expanding screening access during March's Colorectal Cancer Awareness Month, with up to 100 Shield tests provided per selected organization to enhance screening participation.
- No-Cost Screening: All Shield tests will be provided at no cost to patients and participating organizations, aiming to eliminate financial barriers, particularly in underserved and underscreened communities, reflecting the company's commitment to improving access to screening.
- Innovative Screening Tool: The Shield test is the first FDA-approved non-invasive blood-based screening tool designed for individuals aged 45 and older at average risk, offering a more convenient screening option to increase screening rates and reduce colorectal cancer-related mortality.
- Application Deadline: Interested organizations must submit their applications by midnight PST on February 17, 2026, with approval notifications sent via email on February 20, 2026, encouraging groups with strong community and health outreach capabilities to apply.
See More
AI Drives Transformation in Genomics and Biological Manufacturing
- Genomics Advancement: Illumina secures U.S. Medicare reimbursement for its TruSight™ Oncology Comprehensive test, expected to significantly enhance the generation of clinically relevant genomic data, thereby advancing routine genomic profiling in cancer care.
- Liquid Biopsy Expansion: Guardant Health expands the availability of its Shield™ colorectal cancer screening test to U.S. military personnel and their families, enhancing the foundational data generation for precision medicine through ctDNA analysis.
- Drug Discovery Innovation: Recursion Pharmaceuticals leverages AI and machine learning to accelerate drug discovery, emphasizing platform scalability to reduce development time and costs, while attracting institutional interest from firms like ARK Investment Management.
- Spider Silk Production Plan: Kraig Biocraft Laboratories plans large-scale deployment of its transgenic silkworm platform in 2026, aiming to achieve a production capacity of 10 metric tons of recombinant spider silk per month by May, potentially opening new markets for high-performance materials.
See More
GUARDANT HEALTH INC: UBS Increases Price Target from $110 to $175
- Price Increase Announcement: Cub's target price has been raised to $175 from the previous $110.
- Market Impact: This adjustment reflects a significant change in market expectations and valuation for Cub.
See More
Guardant Health's Optimistic Future Outlook
- Positive Financial Performance: Guardant Health achieved positive free cash flow in Q3 2025, one quarter ahead of its goal, indicating strong growth potential in its core oncology business, with expectations to maintain positive cash flow throughout 2026 and beyond, thereby boosting investor confidence.
- Strategic Collaboration Expansion: The company 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 market position in precision oncology.
- FDA Approval Milestone: Guardant360 CDx received FDA approval as a companion diagnostic for Pfizer's Braftovi and Eli Lilly's Erbitux in combination chemotherapy, marking its first FDA approval in colorectal cancer, enhancing the company's competitive edge in the market.
- Optimistic Market Outlook: Although the fourth-quarter financial results for 2025 have yet to be announced, investors maintain an optimistic view of Guardant Health's future, believing that the upcoming update could serve as a catalyst for stock price appreciation, although caution is advised against rushing into purchases in the short term.
See More
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.
See More
