Illumina wins FDA approval for companion diagnostic cancer test

MedTech Dive August 28, 2024
Nick Paul Taylor

Physicians can use the test to identify people eligible for treatment with Bayer’s Vitrakvi and Eli Lilly’s Retevmo cancer drugs.

Dive Brief:

• Illumina said Tuesday the Food and Drug Administration has approved its TruSight Oncology (TSO) Comprehensive test.
• The test uses Illumina’s Nextseq 550Dx sequencing instrument to detect variants in 517 genes using nucleic acids extracted from solid tumor tissue samples.
• Illumina also received two companion diagnostic indications for the test, positioning physicians to use TSO Comprehensive to identify people eligible for treatment with Bayer’s Vitrakvi and Eli Lilly’s Retevmo cancer drugs.

Dive Insight:

Illumina already sells a laboratory developed test for profiling cancer called TSO 500. The product, which targets 523 genes in tissue samples, generated sales...

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