Tuesday, June 18, 2024

Blood Test for Tumor Mutation Profiling: Guardant360 CDx Gains EU Certification

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A tumor mutation profiling blood test developed by Guardant Health, heralded as the first US Food and Drug Administration (FDA) approved blood test for genomic testing of solid tumors, has now obtained certification to be marketed in the European Union (EU). Known as Guardant360 CDx, this test has been certified under the EU’s In Vitro Diagnostic Regulation (IVDR) by the notified body TÜV SÜD Product Service. It is designed for patients with any solid cancerous tumor requiring mutation profiling and serves as a companion diagnostic for identifying individuals who may benefit from targeted therapies for non-small cell lung cancer (NSCLC) and breast cancer.

Originally approved by the FDA in 2020 and granted CE marking under the previous IVD Directive (IVDD) in 2021, Guardant360 CDx represents a significant advancement in cancer diagnostics. By meeting the stringent requirements of the EU’s In Vitro Diagnostic Regulation, Guardant Health’s test underscores its commitment to precision medicine and personalized treatment strategies.

Blood Test Guardant360 CDx Uses NGS Technology for Comprehensive Tumor Profiling

Utilizing next-generation sequencing (NGS) technology, the assay detects genomic alterations using circulating tumor DNA, enabling comprehensive genomic profiling of solid tumors from a single blood draw. Guardant360 CDx covers all genes recommended by the National Comprehensive Cancer Network, providing clinicians with invaluable insights to inform personalized treatment decisions for patients at advanced stages of cancer.

Guardant Health’s co-CEO Helmy Eltoukhy expressed confidence that the EU IVDR certification will facilitate broader adoption of guideline-recommended genomic profiling, leading to the development of new targeted therapies and increasing access to potentially life-changing treatments for advanced cancer patients.

The certification of Guardant360 CDx marks a significant milestone in the context of a rapidly evolving landscape within the liquid biopsy market. Projections indicate that this market is poised to burgeon to $6.8 billion by 2028, exhibiting a robust compound annual growth rate of 20.9%. Amidst this burgeoning growth trajectory, Guardant Health finds itself navigating a competitive arena, with FoundationOne’s Liquid CDx diagnostic emerging as a formidable rival. However, amidst this competition, the industry at large is witnessing a paradigm shift fueled by transformative innovations and technological advancements, notably artificial intelligence (AI).

Blood Test

Blood Test Innovations: AI-Driven Technologies Revolutionize Cancer Diagnostics

The advent of AI-driven technologies has catalyzed a wave of innovation, with companies like Exai Bio harnessing the power of RNA and AI-based platforms to revolutionize the landscape of liquid biopsy. By leveraging sophisticated algorithms and machine learning capabilities, Exai Bio aims to enhance the accuracy and efficiency of cancer detection, thereby offering clinicians and patients alike a more comprehensive and precise diagnostic solution. Furthermore, collaborative efforts between industry giants like Microsoft and Cyted are poised to redefine the boundaries of cancer diagnostics, particularly in the realm of esophageal cancer detection.

These collaborative endeavors seek to harness the synergistic potential of cutting-edge technologies and domain expertise, with the overarching goal of enhancing the efficacy and accessibility of cancer diagnostics. By leveraging advanced tools and technologies, such as AI-driven algorithms and image analysis techniques, these collaborations aim to revolutionize the early detection and management of esophageal cancer, ultimately paving the way for improved patient outcomes and survival rates.

As Guardant Health navigates this dynamic landscape, characterized by fierce competition and unprecedented technological advancements, its EU IVDR certification for Guardant360 CDx serves as a testament to its commitment to precision medicine and patient-centric care. By staying at the forefront of innovation and embracing emerging technologies, Guardant Health continues to redefine the standards of cancer diagnostics, offering clinicians and patients alike a transformative approach to precision oncology.

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Resource: Guardant Health, May 21, 2024

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