Guardant360 CDx Receives FDA Approval as Companion Diagnostic
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 11 2026
0mins
Source: NASDAQ.COM
- FDA Approval: Guardant Health announced that its Guardant360 CDx liquid biopsy test has received approval from the U.S. Food and Drug Administration (FDA) as a companion diagnostic for Boehringer Ingelheim's Hernexeos, marking a significant advancement in the field of precision medicine.
- Targeted Therapy: The test analyzes circulating tumor DNA from blood samples to identify patients with HER2 tyrosine kinase domain activating mutations, thereby helping to determine which patients are eligible for treatment with Hernexeos, enhancing treatment precision.
- Market Position: This approval represents the 27th companion diagnostic indication for Guardant360 CDx globally, further solidifying its leadership position in the liquid biopsy market and showcasing its potential applications across multiple tumor types.
- Strategic Implications: With the FDA approval, Guardant Health not only strengthens the competitiveness of its product portfolio but also opens new opportunities for future collaborations with pharmaceutical companies to develop more targeted therapies, driving the company's continued growth in the precision medicine sector.
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Analyst Views on GH
Wall Street analysts forecast GH stock price to fall
19 Analyst Rating
18 Buy
1 Hold
0 Sell
Strong Buy
Current: 129.110
Low
105.00
Averages
124.69
High
155.00
Current: 129.110
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.
RBC Capital Markets Initiates Guardant Health with Outperform Rating
- Positive Market Outlook: RBC Capital Markets initiated coverage on Guardant Health (GH) with an Outperform rating, highlighting promising growth prospects, particularly with the upcoming Medicare coverage decision expected to boost demand for its breast cancer residual test, Guardant Reveal.
- Underappreciated Tumor Profiling Business: Guardant's tumor profiling business is seen as undervalued due to low market penetration, and the increasing adoption of Guardant Reveal for therapy response monitoring is anticipated to drive demand for its blood-based cancer test, Guardant360 Liquid CDx, enhancing overall company performance.
- Price Increase Potential: The analyst noted that Guardant has the potential to raise average selling prices across its portfolio, especially for the newly approved Guardant360 Liquid CDx, priced at $8,455, significantly higher than the previous $5,000, which will directly impact revenue growth.
- Target Price Setting: Leonard set a target price of $185 for the stock, based on approximately 12x EV/sales, which is a premium to the peer group median of around 6x, reflecting the company's expected 35% year-over-year sales growth from 2026 to 2028, significantly up from the previous estimate of 23%.
See More
Biotech Sector Sees Surge in FDA and Global Approvals
- FDA Approval Boosts Innovation: Guardant Health (GH) secured FDA approval for its Guardant360 CDx liquid biopsy test as a companion diagnostic for Boehringer Ingelheim's HERNEXEOS, highlighting the growing importance of liquid biopsy in advanced cancer treatment, which is expected to drive GH's market share growth.
- Therapy Expansion: Eli Lilly (LLY) received FDA approval for an every-eight-week maintenance dose of EBGLYSS, with Q1 2026 sales surging 141% to $145 million, reflecting strong demand in its immunology portfolio and further solidifying the company's market position.
- China Market Breakthrough: Vor Bio (VOR) announced that Telitacicept received approval from China's NMPA, becoming the only approved therapy for Sjögren's disease in the country, supported by positive Phase 3 trial data, which is expected to significantly improve patient quality of life and expand market reach.
- EU Approval for New Therapy: Sanofi (SNY) secured European Commission approval for Sarclisa in newly diagnosed multiple myeloma patients, based on Phase 3 IRAKLIA trial results, which is expected to enhance Sarclisa's application range and strengthen the company's competitiveness in blood cancer treatment.
See More
Latest Ratings and Outlook from Wall Street
- Optimistic Outlook for SpaceX: Wolfe initiates SpaceX with an outperform rating, highlighting its ability to bring launch costs near zero, creating a competitive moat that could significantly enhance the company's valuation.
- Broadcom Maintains Buy Rating: UBS reiterates its buy rating on Broadcom despite concerns regarding its partnership with Google, suggesting that recent roadmap changes and supply challenges may impact future earnings.
- Williams-Sonoma Upgraded to Buy: Bank of America upgrades Williams-Sonoma from neutral to buy, citing its strong performance in the consumer discretionary sector and expectations of continued market share gains.
- Positive Outlook for Avalo Therapeutics: Bank of America expresses bullish sentiment on Avalo Therapeutics' skin disease treatment, initiating coverage with a buy rating and a $35 price target based on positive clinical trial results.
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Guardant360 CDx Receives FDA Approval for Cancer Diagnosis
- FDA Approval: Guardant Health announced that its liquid biopsy test Guardant360 CDx has received FDA approval as a companion diagnostic for Boehringer Ingelheim's HERNEXEOS, marking a significant advancement in targeted therapy for HER2-mutant non-small cell lung cancer.
- Treatment Indication: HERNEXEOS is indicated for adults with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 tyrosine kinase domain mutations detected by an FDA-authorized test, showcasing the potential of precision medicine.
- Advantages of Liquid Biopsy: Guardant360 CDx is the first FDA-approved liquid biopsy that analyzes circulating tumor DNA through a simple blood draw, enabling clinicians to quickly identify actionable HER2 mutations, thereby enhancing patient treatment matching efficiency.
- Market Impact: With the growing importance of liquid biopsy in cancer treatment, Guardant Health's stock has fluctuated between $40.35 and $134.28 over the past year, currently trading at $130.01, down 0.53%, yet the market remains optimistic about its future growth potential.
See More
Guardant360 CDx Receives FDA Approval as Companion Diagnostic
- FDA Approval: Guardant Health announced that its Guardant360 CDx liquid biopsy test has received approval from the U.S. Food and Drug Administration (FDA) as a companion diagnostic for Boehringer Ingelheim's Hernexeos, marking a significant advancement in the field of precision medicine.
- Targeted Therapy: The test analyzes circulating tumor DNA from blood samples to identify patients with HER2 tyrosine kinase domain activating mutations, thereby helping to determine which patients are eligible for treatment with Hernexeos, enhancing treatment precision.
- Market Position: This approval represents the 27th companion diagnostic indication for Guardant360 CDx globally, further solidifying its leadership position in the liquid biopsy market and showcasing its potential applications across multiple tumor types.
- Strategic Implications: With the FDA approval, Guardant Health not only strengthens the competitiveness of its product portfolio but also opens new opportunities for future collaborations with pharmaceutical companies to develop more targeted therapies, driving the company's continued growth in the precision medicine sector.
See More
FDA Approves Guardant360 CDx for HERNEXEOS Treatment
- FDA Approval: The FDA has approved Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim's HERNEXEOS (zongertinib tablets), marking a new treatment option for patients with HER2-mutant non-small cell lung cancer (NSCLC), which is expected to significantly enhance patient treatment matching rates.
- Liquid Biopsy Advantage: Guardant360 CDx analyzes circulating tumor DNA through a simple blood draw, enabling rapid identification of HER2 mutation patients, providing a faster and less invasive alternative to traditional tissue biopsies, thereby accelerating clinical decision-making.
- Market Impact: This approval marks the 27th CDx indication for Guardant360 CDx globally, further enhancing its clinical utility across multiple tumor types, and is expected to attract broader coverage from Medicare and commercial payers, benefiting over 300 million patients.
- Personalized Treatment: Companion diagnostics are crucial for personalized lung cancer care, and the application of Guardant360 CDx will assist physicians in providing appropriate targeted therapies for HER2-mutant NSCLC patients at critical moments, improving patient survival rates and quality of life.
See More
RBC Capital Markets Initiates Guardant Health with Outperform Rating
- Positive Market Outlook: RBC Capital Markets initiated coverage on Guardant Health (GH) with an Outperform rating, highlighting promising growth prospects, particularly with the upcoming Medicare coverage decision expected to boost demand for its breast cancer residual test, Guardant Reveal.
- Underappreciated Tumor Profiling Business: Guardant's tumor profiling business is seen as undervalued due to low market penetration, and the increasing adoption of Guardant Reveal for therapy response monitoring is anticipated to drive demand for its blood-based cancer test, Guardant360 Liquid CDx, enhancing overall company performance.
- Price Increase Potential: The analyst noted that Guardant has the potential to raise average selling prices across its portfolio, especially for the newly approved Guardant360 Liquid CDx, priced at $8,455, significantly higher than the previous $5,000, which will directly impact revenue growth.
- Target Price Setting: Leonard set a target price of $185 for the stock, based on approximately 12x EV/sales, which is a premium to the peer group median of around 6x, reflecting the company's expected 35% year-over-year sales growth from 2026 to 2028, significantly up from the previous estimate of 23%.
See More
Biotech Sector Sees Surge in FDA and Global Approvals
- FDA Approval Boosts Innovation: Guardant Health (GH) secured FDA approval for its Guardant360 CDx liquid biopsy test as a companion diagnostic for Boehringer Ingelheim's HERNEXEOS, highlighting the growing importance of liquid biopsy in advanced cancer treatment, which is expected to drive GH's market share growth.
- Therapy Expansion: Eli Lilly (LLY) received FDA approval for an every-eight-week maintenance dose of EBGLYSS, with Q1 2026 sales surging 141% to $145 million, reflecting strong demand in its immunology portfolio and further solidifying the company's market position.
- China Market Breakthrough: Vor Bio (VOR) announced that Telitacicept received approval from China's NMPA, becoming the only approved therapy for Sjögren's disease in the country, supported by positive Phase 3 trial data, which is expected to significantly improve patient quality of life and expand market reach.
- EU Approval for New Therapy: Sanofi (SNY) secured European Commission approval for Sarclisa in newly diagnosed multiple myeloma patients, based on Phase 3 IRAKLIA trial results, which is expected to enhance Sarclisa's application range and strengthen the company's competitiveness in blood cancer treatment.
See More
Latest Ratings and Outlook from Wall Street
- Optimistic Outlook for SpaceX: Wolfe initiates SpaceX with an outperform rating, highlighting its ability to bring launch costs near zero, creating a competitive moat that could significantly enhance the company's valuation.
- Broadcom Maintains Buy Rating: UBS reiterates its buy rating on Broadcom despite concerns regarding its partnership with Google, suggesting that recent roadmap changes and supply challenges may impact future earnings.
- Williams-Sonoma Upgraded to Buy: Bank of America upgrades Williams-Sonoma from neutral to buy, citing its strong performance in the consumer discretionary sector and expectations of continued market share gains.
- Positive Outlook for Avalo Therapeutics: Bank of America expresses bullish sentiment on Avalo Therapeutics' skin disease treatment, initiating coverage with a buy rating and a $35 price target based on positive clinical trial results.
See More
Guardant360 CDx Receives FDA Approval for Cancer Diagnosis
- FDA Approval: Guardant Health announced that its liquid biopsy test Guardant360 CDx has received FDA approval as a companion diagnostic for Boehringer Ingelheim's HERNEXEOS, marking a significant advancement in targeted therapy for HER2-mutant non-small cell lung cancer.
- Treatment Indication: HERNEXEOS is indicated for adults with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 tyrosine kinase domain mutations detected by an FDA-authorized test, showcasing the potential of precision medicine.
- Advantages of Liquid Biopsy: Guardant360 CDx is the first FDA-approved liquid biopsy that analyzes circulating tumor DNA through a simple blood draw, enabling clinicians to quickly identify actionable HER2 mutations, thereby enhancing patient treatment matching efficiency.
- Market Impact: With the growing importance of liquid biopsy in cancer treatment, Guardant Health's stock has fluctuated between $40.35 and $134.28 over the past year, currently trading at $130.01, down 0.53%, yet the market remains optimistic about its future growth potential.
See More
Guardant360 CDx Receives FDA Approval as Companion Diagnostic
- FDA Approval: Guardant Health announced that its Guardant360 CDx liquid biopsy test has received approval from the U.S. Food and Drug Administration (FDA) as a companion diagnostic for Boehringer Ingelheim's Hernexeos, marking a significant advancement in the field of precision medicine.
- Targeted Therapy: The test analyzes circulating tumor DNA from blood samples to identify patients with HER2 tyrosine kinase domain activating mutations, thereby helping to determine which patients are eligible for treatment with Hernexeos, enhancing treatment precision.
- Market Position: This approval represents the 27th companion diagnostic indication for Guardant360 CDx globally, further solidifying its leadership position in the liquid biopsy market and showcasing its potential applications across multiple tumor types.
- Strategic Implications: With the FDA approval, Guardant Health not only strengthens the competitiveness of its product portfolio but also opens new opportunities for future collaborations with pharmaceutical companies to develop more targeted therapies, driving the company's continued growth in the precision medicine sector.
See More
FDA Approves Guardant360 CDx for HERNEXEOS Treatment
- FDA Approval: The FDA has approved Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim's HERNEXEOS (zongertinib tablets), marking a new treatment option for patients with HER2-mutant non-small cell lung cancer (NSCLC), which is expected to significantly enhance patient treatment matching rates.
- Liquid Biopsy Advantage: Guardant360 CDx analyzes circulating tumor DNA through a simple blood draw, enabling rapid identification of HER2 mutation patients, providing a faster and less invasive alternative to traditional tissue biopsies, thereby accelerating clinical decision-making.
- Market Impact: This approval marks the 27th CDx indication for Guardant360 CDx globally, further enhancing its clinical utility across multiple tumor types, and is expected to attract broader coverage from Medicare and commercial payers, benefiting over 300 million patients.
- Personalized Treatment: Companion diagnostics are crucial for personalized lung cancer care, and the application of Guardant360 CDx will assist physicians in providing appropriate targeted therapies for HER2-mutant NSCLC patients at critical moments, improving patient survival rates and quality of life.
See More
