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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