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