Research & Development
Guardant360 CDx Liquid Biopsy Granted CE Mark for Comprehensive Tumor Mutation Profiling Across All Solid Cancers
3 March 2021 - - US-based precision oncology company Guardant Health, Inc. (NASDAQ: GH) has CE-marked Guardant360 CDx for tumor mutation profiling, also known as comprehensive genomic profiling, in patients with any solid malignant neoplasm (cancerous tumor), the company said.

The test is also approved as a companion diagnostic to identify non-small cell lung cancer patients with epidermal growth factor receptor 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 US FDA approval in August 2020.

The World Health Organization estimates over 10 m 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.

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% of solid cancer patients.

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.

Guardant Health is a 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.
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