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Guardant Health Guardant360® CDx First FDA-Approved Liquid Biopsy for Comprehensive Tumor Mutation Profiling Across All Solid Cancers

Guardant Health Guardant360® CDx First FDA-Approved Liquid Biopsy for Comprehensive Tumor Mutation Profiling Across All Solid Cancers

Guardant Health, Inc. (Nasdaq: GH) announces that the U.S. Food and Drug Administration (FDA) has approved Guardant360® CDx for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm (cancerous tumor). The Guardant360 CDx 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). Guardant360 CDx offers patients and clinicians a simple, faster blood test to help inform personalized treatment options.

The Guardant360 CDx FDA approval was based on clinical and analytical validation data from over 5,000 samples. In a retrospective analysis of data from pivotal phase III clinical trials, FLAURA and AURA3, non-small cell lung cancer patients identified for treatment with Tagrisso (osimertinib) using the Guardant360 CDx demonstrated progression-free survival rates consistent with those identified using traditional biomarker testing. Since being introduced as a laboratory developed test (LDT), the Guardant360 liquid biopsy LDT has become widely accepted for blood-based CGP with more than 150 peer-reviewed publications.1 It has been used by more than 7,000 oncologists nationwide, and more than 150,000 Guardant360 tests have been performed to date.1 The test is broadly covered by Medicare and many private payers, representing over 170 million lives.1

“The FDA approval of Guardant360 CDx is a landmark decision, demonstrating the value liquid biopsy delivers to oncologists and more importantly, the patients they treat. Traditional tissue biopsy-based tumor profiling, which is often invasive and has longer turnaround times, can contribute to delays in starting treatment and possibly suboptimal therapy. We applaud the FDA for their collaborative review process and for approving the first comprehensive genomic profiling liquid biopsy test,” said Helmy Eltoukhy, Guardant Health CEO. “We are confident that our FDA approval will help accelerate wider adoption of guideline-recommended genomic profiling, increase the number of advanced cancer patients who receive potentially life-changing treatments, and pave the way for new companion diagnostic developments for the Guardant360 CDx.”

“Personalized medicines such as Tagrisso have been truly life-changing for many non-small cell lung cancer patients who have certain EGFR mutations and are most likely to benefit from this medicine,” said Dr. Jhanelle Gray, Senior Member and Chair, Department of Thoracic Oncology, Co-Leader, Chemical Biology & Molecular Medicine Program, Moffitt Cancer Center. “It is crucial that all patients are comprehensively tested before starting treatment to ensure they receive the most appropriate personalized treatment option available.”

Each year, more than 600,000 people die from cancer in the United States,2 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. Already in 2020, more new targeted therapies have been approved by the FDA compared to previous years. Clinical studies show that patients receiving targeted therapies have improved progression-free survival and higher overall response rates relative to chemotherapy or immunotherapy.3-9 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.10-12

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 of its 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.