The US Food and Drug Administration (FDA), through the FDA breakthrough device program, has designated the TruSight Oncology 500 next-generation sequencing assay manufactured by Illumina as a breakthrough device.1

According to the FDA, the breakthrough device program “is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.” As a result of this designation, the agency will expedite its review of Illumina’s newest assay.

The TruSight Oncology 500 platform is a DNA and RNA sequencing assay of tumor specimens. It interrogates the DNA of 523 genes for assessment of small variants, as well as biomarkers related to response to immunotherapy, such as tumor mutational burden and microsatellite instability. It also evaluates RNA from 55 genes to detect gene fusions and splice variants.

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Illumina is seeking to obtain FDA marketing authorization of TruSight Oncology 500 as a pan-cancer companion diagnostic, to be called TruSight Oncology Comprehensive.


  1. Illumina. The FDA grants breakthrough device designation for Illumina’s TruSight assay [press release]. feature-articles/fda-grants-breakthrough-device-designation.html. Published January 22, 2019. Accessed January 24, 2019.