CA-GUARDANT-HEALTH,-INC.
2.3.2021 14:07:10 CET | Business Wire | Press release
Guardant Health, Inc. (Nasdaq: GH) has CE-marked Guardant360® CDx for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm (cancerous tumor). The test is also approved as a companion diagnostic to identify non-small cell lung cancer patients with epidermal growth factor receptor (EGFR ) alterations who may benefit from treatment with Tagrisso® (osimertinib).
The Guardant360 CDx test offers patients and clinicians a simple, faster blood test to help inform personalized treatment options. The Guardant360 CDx received U.S. FDA approval in August 2020.
“Gaining the CE-mark for our Guardant360 CDx test is an important step to making our test more widely accessible to patients around the world. We are committed to helping cancer patients be comprehensively tested to see if they are appropriate for potentially life-changing personalized treatments,” said Helmy Eltoukhy, Guardant Health CEO.
The World Health Organization estimates over 10 million cancer deaths in 2020,1 many of whom may have benefitted from CGP to guide a more personalized treatment plan based on a growing list 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 biopsy, which is the case for as many as 30 percent of solid cancer patients.9-11
Since the company’s inception, Guardant Health has been dedicated to unlocking the potential of liquid biopsy to transform cancer by enabling precision oncology at all stages of the disease. The FDA approval and CE-marking of Guardant360 CDx for tumor mutation profiling and as a companion diagnostic for Tagrisso (osimertinib) represents a critical milestone in the company’s mission to conquer cancer with data. The Guardant360 CDx is also being developed as a companion diagnostic for investigational products in development by other collaborators, including Amgen, Janssen Biotech, Inc., and Radius Health, Inc.
About Guardant Health
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched liquid biopsy-based Guardant360® , Guardant360 CDx, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. These tests fuel development of its LUNAR screening program, which aims to address the needs of asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.
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 the Guardant360 CDx, 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, 2020, in its other reports filed with the Securities and Exchange Commission, including when filed, its Quarterly Report on Form 10-K for the period ended March 31, 2021. 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
- International Agency for Research on Cancer (IARC). World Health Organization. https://lims.ghdna.io/ghlims/logon.jsp. Accessed March 1, 2021.
- 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.
- 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.
- 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.
- 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.
- https://www.hcp.novartis.com/products/tafinlar-mekinist/metastatic-nsclc/efficacy/. Accessed March 1, 2021.
- 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).
- 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.
- 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.
- 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.
- 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
Source: Guardant Health, Inc.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210302005363/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Bending Spoons S.p.A. announces closing of initial public offering2.7.2026 20:35:00 CEST | Press release
Bending Spoons S.p.A. (“Bending Spoons”), a leading technology company, today announces the closing of its initial public offering of an aggregate of 57,971,015 of its ordinary shares, at an initial public offering price of $29.00 per share. The offering consisted of 34,398,640 shares sold by Bending Spoons and 23,572,375 shares sold by certain selling shareholders (the “Selling Shareholders”). The gross proceeds from the offering to Bending Spoons, before deducting underwriting discounts and commissions and other offering expenses, was approximately $953,917,285.50. Bending Spoons did not receive any proceeds from the sale of shares by the Selling Shareholders. Bending Spoons’ ordinary shares began trading on the Nasdaq Global Select Market on July 1, 2026 under the ticker symbol “BSP”. Goldman Sachs International, J.P. Morgan, and Allen & Company LLC are acting as joint lead book-running managers for the offering. Wells Fargo Securities, BofA Securities, Jefferies, Evercore ISI, BNP
Strategic Partnership Between Record Asset Management and Admicasa2.7.2026 19:00:00 CEST | Press release
RAM Swiss Holding AG announces a strategic partnership with Admicasa Holding AG (Admicasa). RAM Swiss Holding AG is a subsidiary of LSE-listed Record Financial Group (Record) and part of the Record Asset Management (RAM) group of companies. The partnership is a milestone in the growth of Admicasa and marks an important step in the continued expansion of Record’s private markets platform. Subject to regulatory approval, the agreement, signed on 1st July 2026, provides RAM Swiss Holding AG with a 50% participation in the Admicasa Fondsleitung AG, part of Admicasa, and establishes a long-term partnership to develop investment opportunities in the Swiss and Global real estate market with a plan to expand into other asset classes in the medium term. RAM is the European asset management arm of Record, the LSE-listed specialist investment group managing USD 115 billion of assets on behalf of institutional clients worldwide. Record's client base comprises pension funds, foundations, sovereign
IQM Quantum Computers Becomes First European Quantum Computing Company Listed on a Major U.S. Exchange2.7.2026 16:47:00 CEST | Press release
IQM begins trading on Nasdaq Global Select Market under the ticker symbol “IQMX” Company enters next phase of growth as a publicly traded leader in full-stack superconducting quantum computing IQM maintains a strong pro forma cash position of EUR 337 million IQM Quantum Computers (Nasdaq: IQMX) (“IQM”, “IQM Quantum Computers” or the “Company”), a global leader in full-stack superconducting quantum computers, today became a publicly traded company following the completion of its business combination with Real Asset Acquisition Corp. (“RAAQ”). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260702960460/en/ IQM Quantum Computers Becomes First European Quantum Computing Company Listed on a Major U.S. Exchange The company’s American Depositary Shares begin trading today on the Nasdaq Global Select Market under the ticker symbol “IQMX”. The listing marks a major milestone for IQM establishing the company as the first European quan
GigaDevice Launches First GD24CL Series I²C EEPROM, Further Expanding Its Non-Volatile Memory Portfolio2.7.2026 16:00:00 CEST | Press release
GigaDevice, a leading semiconductor company specializing in Flash memory, 32-bit microcontrollers (MCUs), sensors, and analog products, announced today the launch of its new GD24CL series I²C EEPROM. The series delivers outstanding performance, comprehensive security protection mechanisms, and excellent reliability that addresses the stringent requirements for stable and long-term storage of critical configuration data. These offered features will benefit applications in industrial, energy, Internet-of-Things (IoT), data centers, and networking. As GigaDevice’s first EEPROM product series, the launch further enhances the company’s non-volatile memory portfolio and provides customers with more dynamic storage solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260702394554/en/ GigaDevice Launches First GD24CL Series I²C EEPROM, Further Expanding Its Non-Volatile Memory Portfolio. The GD24CL series is designed with high
Medical University of Graz Enrolls First Patient in DEEPER CHALLENGE Trial Evaluating Spur® Peripheral Retrievable Scaffold System in a Select CLTI Cohort2.7.2026 13:00:00 CEST | Press release
Reflow Medical, Inc. announces that the Medical University of Graz has enrolled the first patient in the DEEPER CHALLENGE clinical trial. This investigator-initiated, single-center, single-arm, prospective study, supported by a grant, investigates early vessel recoil following below-the-knee treatment using the Spur® Peripheral Retrievable Scaffold System in combination with a commercially available drug-coated balloon. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260701995624/en/ The study investigates early vessel recoil following below-the-knee treatment using the Spur® Peripheral Retrievable Scaffold System in combination with a commercially available drug-coated balloon. The study plans to enroll up to 40 patients with chronic limb-threatening ischemia (CLTI) across two distinct cohorts: patients with diabetes and patients with end-stage renal disease receiving hemodialysis for at least six months, with women comprisi
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom