Guardant Health Receives EU IVDR Certification for Guardant360® CDx Liquid Biopsy for Tumor Mutation Profiling Across All Solid Cancers and Companion Diagnostic Indications

Rhea-AI Summary

Guardant Health announced EU IVDR certification for its Guardant360 CDx liquid biopsy, allowing comprehensive genomic profiling across all solid cancers.

Certification by TÜV SÜD provides a significant milestone, ensuring compliance with stricter EU regulatory standards. This enables broader adoption and faster access to genomic profiling, aiding personalized treatment for advanced cancer patients.

Guardant360 CDx identifies somatic mutations using a blood sample, facilitating targeted therapies for non-small cell lung and breast cancer.

Clinical studies suggest that targeted therapies result in improved progression-free survival and higher response rates.

Adoption of genomic profiling with IVDR-certified liquid biopsy can address challenges like insufficient tissue for molecular profiling, ultimately benefiting more cancer patients.

Since its introduction, Guardant360 has been widely accepted, with over 500,000 tests performed and more than 400 peer-reviewed publications.

Positive

• EU IVDR certification for Guardant360 CDx improves compliance and adoption in the EU.
• Facilitates personalized treatment for advanced cancer patients.
• Guardant360 CDx supports targeted therapies for non-small cell lung and breast cancer.
• Certification by TÜV SÜD marks a significant milestone, ensuring high-quality standards.
• Over 500,000 tests performed and 400 peer-reviewed publications support clinical acceptance.
• Improved progression-free survival and response rates with targeted therapies.
• Helps address insufficient tissue for molecular profiling in 30% of solid cancer patients.

Negative

• Stricter EU regulations may pose challenges for smaller or less-resourced companies.
• Transition to IVDR framework may involve increased costs and administrative burden.

Insights

Oncology Doctor

The new IVDR certification for Guardant360® CDx represents a substantial advancement in precision medicine, especially for patients with advanced cancers. This certification means the test has met stringent EU regulatory standards, which enhances its credibility and reliability for clinical use. By enabling comprehensive genomic profiling (CGP) through a simple blood draw, this test addresses a significant gap in cancer diagnostics, particularly for patients who lack sufficient tissue samples for traditional biopsies. This will likely lead to broader adoption of CGP in the EU, helping more patients receive personalized therapies tailored to their specific tumor mutations.

Market Research Analyst

The IVDR certification for Guardant360® CDx is likely to have a positive impact on Guardant Health's market position within the EU. Stricter regulatory standards under IVDR mean that fewer competitors will be able to quickly enter the market without a similar level of rigorous validation. This exclusivity could enhance Guardant Health's market share and revenue streams from the EU, especially as the demand for precision oncology solutions grows. The certification also enhances the company's reputation, making it a more attractive partner for biopharma companies looking to develop targeted therapies.

Financial Analyst

From a financial perspective, the IVDR certification could drive significant revenue growth for Guardant Health. The EU market presents a substantial opportunity and the certification ensures the company's products can be widely adopted. Historically, regulatory approvals tend to have a favorable impact on stock prices, as they open up new revenue channels and provide a competitive edge. Investors might view this certification as a strong indicator of future financial performance, particularly if it leads to increased partnerships with biopharma companies and broader clinical adoption of the Guardant360® CDx test.

• Blood-based test for comprehensive genomic profiling of solid cancers meets requirements under stricter EU In Vitro Diagnostic Regulation
• IVDR certification from TÜV SÜD enables broader adoption of guideline-recommended genomic profiling to inform optimal therapy selection for patients with advanced cancer

PALO ALTO, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced certification for its Guardant360® CDx blood test under the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746). The certification from TÜV SÜD Product Service is for tumor mutation profiling in patients with any solid cancerous tumor and for companion diagnostic indications to identify patients who may benefit from certain targeted therapies for advanced non-small cell lung cancer and breast cancer.

Under the previous EU regulatory framework (IVD Directive 98/79/EC), manufacturers were able to self-certify most of their molecular assays. Under the IVDR most must obtain a conformity assessment and certificate from an accredited company, called a notified body, such as TÜV SÜD. Guardant360 CDx is a next generation sequencing (NGS)-based assay that detects genomic alterations using circulating tumor DNA from blood. The test allows clinicians to use tumor mutation profiling, also known as comprehensive genomic profiling (CGP), to identify somatic mutations in solid tumors from a simple blood draw to inform personalized treatment decisions for their patients with advanced cancer.

“The IVDR certification for the Guardant360 CDx liquid biopsy is a significant milestone for cancer care in the EU, as the test provides faster access to comprehensive genomic profiling for oncologists and, more importantly, for the patients they treat,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “We are confident that this certification will help accelerate wider adoption of guideline-recommended genomic profiling, pave the way for the development of new targeted therapies, and increase the number of advanced cancer patients who receive potentially life-changing treatments.”

More than 1.2 million people are predicted to die from cancer in the EU in 2024,¹ many of whom could benefit from comprehensive genomic profiling to guide a more personalized treatment plan, based on the growing availability of effective CGP-informed targeted therapies. Clinical studies show that patients receiving targeted therapies have improved progression-free survival and higher overall response rates relative to chemotherapy or immunotherapy.^2-8

“Clinical adoption of targeted therapies lags behind medical guidelines due to several factors, including insufficient tissue for molecular profiling, which is the case for as many as 30 percent of solid cancer patients,” said Nicola Normanno, MD, scientific director of IRCCS Romagna Institute for the Study of Tumors (IRST) "Dino Amadori" in Meldola, Italy.^9-11 “Expanding the use of genomic profiling with IVDR-certified liquid biopsy will help the cancer care community establish more clinically relevant biomarkers to improve diagnosis and quickly identify the personalized therapies that patients can benefit from.”

Under the IVDR, Guardant360 CDx is certified as a companion diagnostic to identify patients with non-small cell lung cancer who may benefit from treatment with TAGRISSO® (osimertinib), RYBREVANT® (amivantamab), or LUMYKRAS® (sotorasib), and advanced breast cancer patients with ESR1 mutations who may benefit from treatment with ORSERDU™ (elacestrant).

Personalized medicines such as these have been life-changing for many cancer patients who have targetable mutations and are thus most likely to benefit from a particular therapy. IVDR certification for Guardant360 CDx is significant because it ensures continued broad access in the EU to comprehensive genomic profiling, which plays a critical role in helping biopharma companies identify patients to enroll in clinical trials and helping oncologists match patients to new precision medicines that target solid tumors.

“I am pleased that the new IVDR framework provides strict and high quality standards for diagnostic tools, because this will contribute to better standard of care and clinical trial protocols,” said Peter Fasching, MD, professor of Obstetrics and Gynecology and coordinator of the Breast Cancer Center and the Gynecological Cancer Center at the Comprehensive Cancer Center Erlangen-EMN, Germany. “Using IVDR-certified liquid biopsy more broadly will allow us to find more biomarkers that can be targeted in the future and gives clinicians confidence that they are using a highly validated tool to select the optimal individualized treatment plan for the patient.”

Since being introduced, the Guardant360 test has become widely accepted for blood-based comprehensive genomic profiling, with more than 400 peer-reviewed publications. It has been used by more than 12,000 oncologists, with more than 500,000 tests performed to date.

About Guardant360 CDx

The first FDA-approved blood test for complete genomic testing, Guardant360 CDx received U.S. FDA approval in August 2020 and CE mark for tumor mutation profiling in March 2021. For oncologists, the test provides comprehensive genomic results from a simple blood draw in seven days, helping them move beyond the limitations of tissue biopsies to rapidly obtain clinically relevant information in time to match patients to the optimal personalized treatment. Guardant360 CDx covers all genes recommended by the National Comprehensive Cancer Network, including those most relevant to clinical care and NSCLC treatment guidelines. For more information, visit guardant360cdx.com.

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 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 helping doctors select the best treatment for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

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, 2023, 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 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.

References

1. https://pubmed.ncbi.nlm.nih.gov/38286716/
2. Shaw AT, Riely GJ, Bang Y-J, et al. Crizotinib in ROS1-rearranged advanced non-small-cell lung cancer (NSCLC): updated results, including overall survival, from PROFILE 1001. Ann Oncol. 2019;30(7):1121-1126.
3. Ramalingam SS, Gray JE, Ohe Y, et al. Osimertinib vs comparator EGFR-TKI as first-line treatment for EGFRm advanced NSCLC (FLAURA): Final overall survival analysis. Ann Oncol. 2019;30(5): v851-v934.
4. Garon EB, Hellmann MD, Costa EC, et al. Five-year long-term overall survival for patients with advanced NSCLC treated with pembrolizumab: Results from KEYNOTE-001. J Clin Oncol. 2019;37(28):2518-2527.
5. Camidge DR, Dziadziuszko R, Peters S, et al. Updated Efficacy and Safety Data and Impact of the EML4-ALK Fusion Variant on the Efficacy of Alectinib in Untreated ALK-Positive Advanced Non–Small Cell Lung Cancer in the Global Phase III ALEX Study. J Thorac Oncol. 2019;14(7):1233-1243.
6. https://www.hcp.novartis.com/products/tafinlar-mekinist/metastatic-nsclc/efficacy/. Accessed March 1, 2021.
7. Gadgeel SM, Garassino MC, Esteban E, et al. KEYNOTE-189: Updated OS and progression after the next line of therapy (PFS2) with pembrolizumab (pembro) plus chemo with pemetrexed and platinum vs placebo plus chemo for metastatic nonsquamous NSCLC. J Clin Oncol. 2019;37(suppl; abstr 9013).
8. Sandler A, Gray R, Perry MC, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006;14;355(24):2542-2550.
9. Hagemann IS, Devarakonda S, Lockwood CM, et al. Clinical Next-Generation Sequencing in Patients with Non–Small Cell Lung Cancer. Cancer. 2015;121:631-639.
10. Parsons HA, Beaver JA, Cimino-Mathews A, et al. Individualized Molecular Analyses Guide Efforts (IMAGE): A Prospective Study of Molecular Profiling of Tissue and Blood in Metastatic Triple-Negative Breast Cancer. Cancer Res. 2017;23(2); 379–386.
11. Wyatt AW, Annala M, Aggarwal R, et al. Concordance of Circulating Tumor DNA and Matched Metastatic Tissue Biopsy in Prostate Cancer. J Natl Cancer Inst. 2018;110(1):djx118.

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20240521131491/en/

Investor Contact:

Zarak Khurshid

investors@guardanthealth.com

Media Contact:

Michael Weist

press@guardanthealth.com

+1 650-647-3643

Source: Guardant Health, Inc.

FAQ

What is the significance of the EU IVDR certification for Guardant360 CDx?

The EU IVDR certification ensures compliance with stricter regulatory standards, enabling broader adoption of genomic profiling for advanced cancer patients.

What cancers can Guardant360 CDx profile?

Guardant360 CDx can profile all solid cancers using a liquid biopsy approach.

How does Guardant360 CDx facilitate targeted therapies?

The test identifies somatic mutations using circulating tumor DNA from blood, aiding in personalized treatment decisions for advanced cancer patients.

What targeted therapies does Guardant360 CDx support?

Guardant360 CDx supports targeted therapies for non-small cell lung cancer (TAGRISSO, RYBREVANT, LUMYKRAS) and advanced breast cancer (ORSERDU).

What are the clinical benefits of using Guardant360 CDx?

Clinical studies show improved progression-free survival and higher response rates compared to chemotherapy or immunotherapy.

How widely accepted is Guardant360 CDx?

Guardant360 CDx has been widely accepted with over 500,000 tests performed and more than 400 peer-reviewed publications.

What challenges does Guardant360 CDx address in cancer profiling?

Guardant360 CDx helps address insufficient tissue for molecular profiling, which affects up to 30% of solid cancer patients.