January 22, 2019
Today, Illumina announces that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for 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 (TSO 500), designed to detect known and emerging solid tumor biomarkers. Illumina is seeking FDA approval of the assay as a companion diagnostic.
“This is a very significant milestone in the development of a diagnostic device that will allow us to establish standards for accurate and reproducible oncology testing,” said Garret Hampton, Ph.D., Senior Vice President of Clinical Genomics at Illumina. “This designation fast tracks our work with the FDA, so we can bring companion diagnostics to market that pinpoint genomic alterations, giving oncologists the opportunity to select precision therapies to manage their patient’s cancer.”
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 (TMB) and microsatellite instability (MSI), features that are potentially key biomarkers for immunotherapies.
This is a very significant milestone in the development of a diagnostic device that will allow us to establish standards for accurate and reproducible oncology testing.
The Breakthrough Device Program, which supersedes the FDA’s Expedited Access Pathway (EAP), 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.
“The ability to work in conjunction with the FDA, to leverage their expertise and support, is invaluable as we work toward obtaining FDA approval,” said Karen Gutekunst, Vice President of Regulatory Affairs at Illumina. “Advancements such as this will continue to revolutionize treatment for millions of cancer patients who will be able to find the right treatment, faster, when facing a disease where every minute and every decision matter.”