FDA has granted Breakthrough Device Designation for Illumina’s its pan-cancer assay.
Currently in development, with plans to be marketed as TruSight Oncology Comprehensive, the assay is based on the content of Illumina’s TruSight Oncology 500, designed to detect known and emerging solid tumor biomarkers. Illumina is seeking FDA approval of the assay as a companion diagnostic.
The assay utilizes both DNA and RNA from tumor samples to identify key somatic variants underlying tumor progression. These variants include small DNA variants, fusions, and splice variants, as well as immunotherapy-associated biomarkers such as tumor mutational burden and microsatellite instability, features that are potentially key biomarkers for immunotherapies.
The Breakthrough Device Program, which supersedes the FDA’s Expedited Access Pathway, is designed for certain medical devices and device-led combination products that provide for more effective treatment in diagnosing life-threatening or irreversibly debilitating diseases or conditions.
The Breakthrough Devices Program contains features of the EAP, as well as the Innovation Pathway, both of which were intended to facilitate the development and expedite the review of breakthrough technologies.
With Breakthrough Device Designation, Illumina’s assay will receive priority review, meaning that the review of the submission is prioritized in the queue and will receive additional review resources, as needed.
