FDA has recently granted a breakthrough device designation to Illumina, San Diego, for the company’s pan-cancer assay, which is now under development.

Planned for market release as TruSight oncology comprehensive, the assay is based on the content of Illumina’s TruSight oncology 500, a test designed to detect known and emerging solid tumor biomarkers. Illumina is seeking FDA approval of the new 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,” says Garret Hampton, PhD, senior vice president for clinical genomics at Illumina. “This designation fast tracks our work with 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. Variants detected include small DNA variants, fusions, and splice variants, as well as immunotherapy-associated biomarkers for tumor mutational burden and microsatellite instability—features that are potentially key biomarkers for qualifying patients to receive immunotherapies.

The breakthrough device program is designed for certain medical devices and device-led combination products that provide for more-effective diagnosis and treatment of life-threatening or irreversibly debilitating diseases or conditions. With the breakthrough device designation, Illumina’s assay will receive priority review, meaning that agency review of the company’s premarket submission will be prioritized in the queue and will receive additional review resources, as needed.

“The ability to work in conjunction with FDA, to leverage their expertise and support, is invaluable as we work toward obtaining FDA approval,” says Karen Gutekunst, vice president for 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.”

For further information, visit Illumina.