FDA grants EAP designation to Guardant's NGS-based liquid biopsy

Guardant Health Inc. (Redwood City, Calif.) said FDA granted Expedited Access Pathway (EAP) designation to its Guardant360 assay, a comprehensive next-generation sequencing (NGS)-based liquid biopsy test for advanced cancer. The company plans to submit a PMA to FDA for the assay by year end.

The EAP program seeks to grant expedited development, assessment and review to medical devices that address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions...