FDAnews
www.fdanews.com/articles/185711-fda-grants-eap-designation-to-guardants-ngs-based-liquid-biopsy

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

February 21, 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.

View today's stories