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.
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.
- 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.
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
New F1 Insights Powered by AWS Will Help FORMULA 1 Fans Make Sense of Split-Second Decisions on the Track15.4.2021 09:30:00 CEST | Press release
Today, Amazon Web Services (AWS), an Amazon.com, Inc. company (NASDAQ: AMZN), and FORMULA 1 (F1) (NASDAQ: FWONA, FWONK) are introducing six new F1 Insights powered by AWS that will roll out through the 2021 racing season. The new additions mean a total of 18 AWS-powered stats will be available to fans by the end of the season. F1 Insights powered by AWS are real-time racing statistics, displayed as on-screen graphics, that transform the fan experience before, during, and after each race by providing the data and analysis fans need to interpret driver and team race strategy and performance. The first new stat, Braking Performance, will debut at the GRAND PRIX in Italy, April 16-18. The new set of statistics for 2021 will use a range of AWS technologies, including machine learning, to help fans better understand and highlight potential race outcomes and compare their favorite drivers and cars.For more information about AWS and its involvement with F1, including the 12 previously released
Peter Windisch Appointed Chief Technology Officer at Excelya15.4.2021 09:03:00 CEST | Press release
Today, Excelya, the leading European contract research organization, has announced the appointment of Peter Windisch to the position of Chief Technology Officer (CTO). As CTO, Peter will aim to leverage data and technology to further optimize its client offer. He will be made a member of the Executive Committee and will be based in Germany. Peter was most recently VP of Operations and Client Partner at PRA Health Sciences and has worked for decades in various leadership positions in health and technology. He began his career in health as a Manager of Information Technology and Data Management before moving up the ranks to Managing Director of various regions in Europe at IMEREM (now part of PRA Health Sciences) and ReSearch Pharmaceutical Services. Alan Morgan, CEO of Excelya: “Excelya is investing heavily in technology to better support our clients and patients for the trials that we are managing. Innovation and efficiency are at the heart of what we do. This new position recognizes t
Completion of the Third Clinical Trial - an Important Achievement for Medicortex Finland15.4.2021 08:25:00 CEST | Press release
Medicortex Finland Oy, a biotechnology company developing a breakthrough biomarker-based diagnostic kit for brain injury detection, completed collection of body fluid samples in its third large clinical study. Children and adolescents were recruited who visited the hospital with a suspected mild traumatic brain injury or concussion. "Collecting the samples in this large clinical trial is a significant achievement for Medicortex, and represents an important step forward in the development of the ProbTBITM, a diagnostic kit for early detection of head injury" said Dr. Adrian Harel, Chief Executive Officer of Medicortex Finland. "Brain injury is a devastating condition leading to medical complications if not diagnosed. We have the opportunity to develop a portable non-invasive test for quick detection of mild traumatic brain injury (TBI) and concussion, and thereby help young patients and families who so desperately need it.” Dr. Harel added. In the current clinical study Medicortex colle
Valbiotis: Largely Successful Capital Increase Through a Private Placement Totaling 15 Million Euros15.4.2021 07:35:00 CEST | Press release
Regulatory News: Valbiotis (Paris:ALVAL) (FR0013254851 – ALVAL, PEA-PME eligible), a Research & Development company committed to scientific innovation for the treatment and prevention of metabolic diseases, today announces the large successful capital increase through a private placement open to certain categories of beneficiaries launched the previous day and achieved using an accelerated bookbuilding process. Given the very high demand from French and international investors, Valbiotis decided to set the amount of the capital increase at 15 million euros, compared to approximately 12 million euros initially forecast. Sébastien PELTIER, CEO of Valbiotis stated: "I am extremely grateful to all the new investors who participated in this capital increase, as well as all our historic shareholders who continue to support our company in its mission and its development. This capital increase is key, as it will enable us to accelerate our development program for the prevention of high blood p
ABB Issues Trading Update Following Better-Than-Anticipated Performance in Q115.4.2021 06:46:00 CEST | Press release
ABB is publishing preliminary information on its first-quarter 2021 results, which according to the information available to the company, is better than the latest company guidance and current market consensus. The preliminary results were driven by a stronger-than-anticipated market development, especially during the last weeks of March, and relates primarily to the short-cycle business. Quarterly demand is likely to have been supported by customer stock-building activities related to both component availability constraints and rising commodity prices in the industry. Preliminary results for first quarter 2021: ($ millions, unless otherwise indicated) Change Q1 2021 Q1 2020 US$ Comparable1 Orders ~7,750 7,346 ~+6% ~+1% Revenues ~6,900 6,216 ~+11% ~+7% Operational EBITA2, % ~13.5% 10.2% ~+330 pts On the back of recent market developments, ABB is raising its revenue guidance for full year 2021 outlook and now anticipates comparable revenue growth of ~5% or higher (previously: comparable
Mattel Unveils First-of-its-Kind, CarbonNeutral ® Matchbox ® Tesla Roadster Die-cast Vehicle Made from 99% Recycled Materials to Serve as Brand Blueprint15.4.2021 06:01:00 CEST | Press release
Today, Mattel, Inc. (NASDAQ: MAT) announced Drive Toward a Better Future, its product roadmap to make all Matchbox die-cast cars, playsets and packaging with 100% recycled, recyclable or bio-based plastic by 2030. This is in line with Mattel’s goal to achieve 100% recycled, recyclable or bio-based plastic materials across all its products and packaging by 2030. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210414006005/en/ Mattel is unveiling the Matchbox Tesla Roadster, its first die-cast vehicle made from 99% recycled materials and certified CarbonNeutral®*. The Matchbox Tesla Roadster will be available starting in 2022. (Photo: Business Wire) To illustrate these principles, Mattel is unveiling the Matchbox TeslaRoadster, its first die-cast vehicle made from 99% recycled materials and certified CarbonNeutral®*. The Matchbox Tesla Roadster will be available starting in 2022. The reimagined broader Matchbox brand includes n
imc Test & Measurement Joins Battery Ventures’ Test and Measurement Platform15.4.2021 06:01:00 CEST | Press release
Battery Ventures, a global, technology-focused investment firm, has reached an agreement to acquire imc Test & Measurement (“imc”), a global provider of productive test and measurement hardware and software solutions. Joining Battery’s group of companies in the test and measurement market, imc will operate alongside U.S.-based Audio Precision and Denmark-based GRAS Sound & Vibration, which were acquired by Battery in 2018 and 2020, respectively. Terms of the transaction were not disclosed. Founded in 1988, imc is a well-known provider of state-of-the-art data acquisition systems and software. The company serves customers in markets such as automotive, energy, rail and aerospace, among others. In partnership with Battery, Audio Precision and GRAS, imc will continue its long-standing tradition of pursuing growth across the sectors it serves. Joining forces with Audio Precision and GRAS, imc will benefit from business synergies across the group of companies and drive its future growth thr
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