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Guardant Health receives certification required under EU In Vitro Diagnostic Regulation for Guardant360 CDx liquid biopsy test
Precision Medicine
May 21, 2024
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Precision Medicine

Precision Medicine

May 21, 2024

Guardant Health receives certification required under EU In Vitro Diagnostic Regulation for Guardant360 CDx liquid biopsy test

Product updates

  • Guardant Health has received the certification required under In Vitro Diagnostic Regulation (IVDR 2017/746) in the EU for its Guardant360 CDx liquid biopsy test from accreditation company TUV SUD.

  • TUV SUD Product Service certification covers tumor mutation profiling for patients with solid tumors and companion diagnostics to identify those who may benefit from targeted therapies for advanced non-small cell lung cancer and breast cancer.

  • Under the previous EU regulatory framework, as per the IVDR, most assays now require a conformity assessment and certification from an accredited entity, known as a notified body, such as TUV SUD.

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