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Medical Devices / Submissions and Approvals

FDA Grants EAP Designation to Guardant's NGS-Based Liquid Biopsy

Feb. 22, 2018

The FDA granted Guardant Health Expedited Access Pathway designation for its Guardant360 assay, a next-generation sequencing (NGS)-based liquid biopsy test for advanced cancer.

The assay has been marketed as a laboratory-developed test since 2014 and is available in more than 30 countries.

The EAP program offers faster reviews for medical devices that address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions.

The company plans to submit a PMA to the FDA for the assay by year end.

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