Business Wire

CA-GUARDANT-HEALTH,-INC.

2.3.2021 14:07:10 CET | Business Wire | Press release

Share
Guardant360® CDx Liquid Biopsy CE-Marked for Comprehensive Tumor Mutation Profiling Across All Solid Cancers

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

  1. International Agency for Research on Cancer (IARC). World Health Organization. https://lims.ghdna.io/ghlims/logon.jsp. Accessed March 1, 2021.
  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 

Source: Guardant Health, Inc.

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

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

Mobix Labs Signs Definitive Agreement to Acquire Vision Aerial, Accelerating Global Drone Platform for National Security and Aerial Intelligence24.7.2026 13:00:00 CEST | Press release

Transaction accelerates Mobix Labs’ global aerial intelligence strategy and National Security Matters Initiative Mobix Labs, Inc. (Nasdaq: MOBX) today announced that it has signed a definitive agreement to acquire Vision Aerial, Inc., a U.S.-based designer and manufacturer of American-built, National Defense Authorization Act (NDAA)-compliant unmanned aerial systems. The definitive agreement moves the transaction beyond the previously announced letter of intent and represents a major step toward closing an acquisition that would expand Mobix Labs into one of the world’s most important technology growth markets: secure drones, autonomous aerial systems and aerial intelligence for national security, critical infrastructure, energy, public safety, industrial inspection and government operations. Vision Aerial’s customers and end-users include the U.S. Air Force, U.S. Navy, government agencies, energy and utility operators, research institutions and other organizations requiring performanc

Enhertu® Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer24.7.2026 13:00:00 CEST | Press release

Recommendation based on DESTINY-Breast09 phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years If approved, Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab would become first new treatment in the EU in more than a decade for first-line HER2 positive metastatic breast cancer Enhertu® (trastuzumab deruxtecan) in combination with pertuzumab has been recommended for approval in the European Union (EU) for the first-line treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP)

SLB Announces Second-Quarter 2026 Results24.7.2026 12:50:00 CEST | Press release

Revenue of $8.97 billion increased 3% sequentially and 5% year on year GAAP EPS of $0.52 increased 4% sequentially and decreased 30% year on year EPS, excluding charges and credits, of $0.55 increased 6% sequentially and decreased 26% year on year Net income attributable to SLB of $786 million increased 5% sequentially and decreased 22% year on year Adjusted EBITDA of $1.90 billion increased 7% sequentially and decreased 7% year on year Cash flow from operations was $1.36 billion and free cash flow was $716 million Board approved quarterly cash dividend of $0.295 per share SLB (NYSE: SLB) today announced results for the second-quarter 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722694386/en/ The exterior of the SLB headquarters in Houston, Texas.Second-Quarter Results(Stated in millions, except per share amounts)Three Months EndedChangeJun. 30, 2026Mar. 31, 2026Jun. 30, 2025SequentialYear-on-yearRevenue $8,972 $8

NIQ Expands GenAI Capabilities Across gfknewron, Turning Trusted Intelligence into Decisions Faster24.7.2026 12:30:00 CEST | Press release

New capabilities help businesses uncover trends faster, simplify complex analysis, and accelerate confident decision-making NIQ (NYSE: NIQ), a leader in consumer intelligence, today announced the expansion of AI-powered Smart Insights across its gfknewron® platform. By bringing together markets and categories into a single view, gfknewron enables businesses to transform complex market, consumer and supply chain data into clear, actionable intelligence quickly. The latest enhancements help users identify trends, opportunities and performance drivers more quickly, reducing the time required to analyze large datasets and accelerating confident decision-making across teams. As brands and retailers face growing pressure to respond quickly to changing consumer behavior and market dynamics, the ability to unlock meaningful insights from increasingly rich datasets has become a significant competitive advantage. As AI is only as effective as the intelligence behind it, Smart Insights helps busi

Thales to Strengthen Romania’s Airspace Protection With Twelve Ground Master 200 MM/A Radars24.7.2026 10:05:00 CEST | Press release

The Romanian General Directorate for Armaments and the French Direction Générale de l’Armement (DGA – the French defence procurement agency) have signed an agreement to supply twelve Thales GM200 Multi-Mission All-in-one (GM200 MM/A) radars to protect the Romanian airspace. This government-to-government agreement underlines the high level of partnership between France and Romania, within the framework of the European Union’s SAFE funding programme, in order to bolster Europe’s defence capabilities. The GM200 MM/A is part of Thales’ proven Ground Master radar family, which has already been deployed in over 40 countries, including now in Romania. In a context of growing collaboration between European nations to bolster collective security, the Romanian General Directorate for Armaments has just signed a landmark agreement with France’s Direction Générale de l’Armement (DGA) to acquire twelve Thales Ground Master 200 Multi-Mission All-in-one (GM200 MM/A) radars. This government-to-governm

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye