by NCI Staff, September 24, 2020, Redwood City, CA. 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. FoundationOne Liquid CDx, meanwhile, can identify changes in more than 300 genes, as well as other genetic features that make tumors more susceptible to treatment with certain immunotherapies. The Guardant360 test is broadly covered by Medicare for use across the vast majority of advanced solid tumors, including patients with metastatic NSCLC. FDA has approved the Guardant360 CDx from Guardant Health, Redwood City, Calif, the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a deadly form of metastatic non-small cell lung cancer (NSCLC). The test is intended to be used as a companion diagnostic to identify non-small cell lung cancer (NSCLC) ... Guardant360 CDx is a single-site assay performed at Guardant Health, Inc. “Again, that might be a situation where we prefer to use a liquid biopsy instead,” Dr. Park said. Certain cancer therapies provide better patient outcomes and fewer side effects than broad-based chemotherapy. The drug pembrolizumab (Keytruda) is approved for patients with tumors that have this feature, regardless of where in the body the cancer started growing.Â. Redwood City, CA 94063, Telephone: 855.698.8887 Such risks and uncertainties include those discussed under the caption “Risk Factors” in Guardant Health’s Annual Report on Form 10-K for the year ended December 31, 2019, its Quarterly Report on Form 10-Q for the period ended March 31, 2020, and in its other reports filed with the Securities and Exchange Commission. Two blood tests recently approved by FDA for use in some people with cancer, known as liquid biopsies, identify genetic changes by scanning DNA that tumors have shed into the blood. Companion diagnostics increase the probability of clinical success by identifying patients with the presence of biomarkers or disease ... Guardant Health, Inc. Illumina, Inc. They are considered less invasive and quicker than a traditional tissue biopsy.Â, “Even though the tests have been around for a while, we don’t know how useful they’re really going to be in the clinical setting,” said Ben Ho Park, M.D., Ph.D., of Vanderbilt-Ingram Cancer Center. 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. Also in August, the agency approved a liquid-biopsy platform from Guardant Health and approved its use as a companion diagnostic for a certain form of non-small cell lung cancer. News release. For pharmaceutical companies, Guardant360 CDx, Guardant360 LDT, and GuardantOMNI offer a way to accelerate clinical development programs through retrospective sample analysis, patient screening and clinical trial enrollment, and companion diagnostic development to support commercialization of new drugs. News release. [email protected]. These forward-looking statements are based on current expectations, forecasts, assumptions and information available to Guardant Health as of the date hereof, and actual outcomes and results could differ materially from these statements due to a number of factors, 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. Guardant Health, Inc. announced a strategic collaboration with Janssen Biotech, Inc. to pursue regulatory approval and commercialization of the Guardant360® CDx as a companion diagnostic for amivantamab, an investigational EGFR-MET bispecific antibody being studied in … REDWOOD CITY, Calif., Jan. 13, 2020 (GLOBE NEWSWIRE) -- Guardant Health, Inc. (Nasdaq: GH), announces a strategic collaboration to develop and help support commercialization of a blood-based companion diagnostic (CDx) test for Amgen’s AMG 510, an investigational oral therapy that inhibits KRAS G12C mutant protein, globally. 1. AstraZeneca has tapped Guardant Health to develop blood-based companion diagnostics for its cancer treatments Tagrisso and Imfinzi. Both Guardant360 CDx and FoundationOne Liquid CDx are approved for people with any solid cancer (e.g., lung, prostate), but not for those with blood cancers. Available in 41 countries across AMEA, the company’s Guardant360 test provides quick and accurate comprehensive genomic profiling (CGP) information from a simple blood draw in seven days upon sample receipt in the laboratory. REDWOOD CITY, Calif., July 08, 2020 (GLOBE NEWSWIRE) -- Guardant Health, Inc. (Nasdaq: GH) today announced a strategic collaboration with Janssen Biotech, Inc. (Janssen) to pursue regulatory approval and commercialization of the Guardant360® CDx as a companion diagnostic for amivantamab, an investigational EGFR-MET bispecific antibody being studied in the treatment of non-small cell lung cancer (NSCLC). He replaces Derek Bertocci who is retiring. Guardant Health received a milestone approval from the FDA for its cancer test, as the first liquid biopsy able to genetically profile solid tumors anywhere in the body through a single blood draw. Follow a manual added link. Dec 13, 2018 | staff reporter. 4.1.2 Companion Diagnostics 4.1.3 Funding 4.1.4 Technology Environment 4.1.5 Target Solutions ... Guardant Health to Develop Companion Diagnostic Tests for AstraZeneca ; 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. Guardant Health received a milestone approval from the FDA for its cancer test, as the first liquid biopsy able to genetically profile solid tumors anywhere in the body through a single blood draw. Guardant Health AMEA Wins Frost & Sullivan’s Market Leadership Award for Liquid Biopsy in Precision Oncology in Asia, Middle East and Africa [email protected], Media inquiries: The FDA has approved Guardant360 CDx for comprehensive genomic profiling in patients with any solid malignant neoplasm, according to Guardant Health, the developer of the liquid biopsy. Guardant Health , Inc. (Nasdaq: GH) today announced a strategic collaboration with Janssen Biotech, Inc. (Janssen) to pursue regulatory approval and commercialization of the Guardant360 ® CDx as a companion diagnostic for amivantamab, an investigational EGFR-MET bispecific antibody being studied in the treatment of non-small cell lung cancer (NSCLC). At some hospitals and cancer centers, groups of doctors with different specialties meet to discuss the patients’ tumor profiling test results. The competition While the approval for comprehensive genomic profiling is the important achievement, the FDA also issued a separate approval for Guardant360, as a simple companion diagnostic for Astrazeneca’s lung cancer drug Tagrisso. Both tests can be used for two different purposes: as a companion diagnostic test and for general tumor profiling. However, coverage policies for liquid biopsies continue to change. AACR 2020: Liquid Biopsy Company Guardant Health Presents Colorectal Cancer Data, Outlines Plans For Regulatory Approval August 7, 2020. FoundationOne Liquid CDx, made by Foundation Medicine, was approved as a companion diagnostic for three lung cancer therapies and a prostate cancer therapy. The Redwood City, CA-based company’s Guardant 360 CDx is at the center of the collaboration with Janssen. Doctors have traditionally based treatment decisions on features like the organ in which the cancer started growing, whether the cancer has spread, and whether the patient has other health conditions. Guillermo’s Story. Now the consensus is that genetic changes found in the blood accurately represent those present in the tumor, she said. Join to Connect. A simple blood draw helps cancer patients get the right drug. Guardant Health. The FDA has approved Guardant360 CDx for comprehensive genomic profiling in patients with any solid malignant neoplasm, according to Guardant Health, the developer of the liquid biopsy. In many cases, the cost is only covered if the test was used to check for genetic changes that have companion diagnostic approvals. Now FDA Approved. Guardant Health. FDA approves first liquid biopsy NGS companion diagnostic. In other words, “the regulations haven’t caught up to the science,” she added.Â. Guardant Health, Inc. 505 Penobscot Dr. Redwood City, CA 94063 USA 1 Intended Use Guardant360® CDx is a qualitative next generation sequencing-based in vitro diagnostic ... Companion Diagnostic Indications Indication Biomarker Therapy Non-small cell lung cancer (NSCLC) The data showed that the results of both tests agreed with results from other tumor profiling tests that have been proven accurate.Â. Using next-generation sequencing, the Guardant360 test analyzes 74 genes using cell-free tumor DNA from patient blood samples. Many times, there is not enough tumor DNA in the patient’s blood for a test to reliably pick up any genetic changes, he explained. REDWOOD CITY, Calif., Jan. 13, 2020 (GLOBE NEWSWIRE) -- Guardant Health, Inc. (Nasdaq: GH), announces a strategic collaboration to develop and help support commercialization of a blood-based companion diagnostic (CDx) test for Amgen’s AMG 510, an investigational oral therapy that inhibits KRAS G12C mutant protein, globally. The newly approved tests identify genetic changes, including mutations, by scanning DNA that tumors have shed into the blood.Â. Guardant Health Guardant360® CDx First FDA-Approved Liquid Biopsy for Comprehensive Tumor Mutation Profiling Across All Solid Cancers. Some of the additional genetic changes covered by the tests are targeted by FDA-approved therapies, but the tests don’t have companion diagnostic designations for those therapies. But if a patient’s tumor can be easily and safely accessed for a core biopsy, that would be preferred over a liquid biopsy, he noted. 505 Penobscot Dr. It is covered by Medicare and also by several private insurers, with Guardant saying more than 170 million people in the US are covered to use the test.

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