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 of more than $100 million in 2023, Illumina CEO Jacob Thaysen said on an earnings call in February. Thaysen said the test was expected to have “high double-digit growth” into this year, “and we don't see any end to that right now.”
The FDA approval clears Illumina to provide a TSO test as an in vitro diagnostic. Like TSO 500, the newly approved test uses Nextseq 550Dx to analyze tumor tissue samples. The diagnostic detects single nucleotide variants, multi-nucleotide variants, insertions, deletions from DNA and more.
NTRK and RET fusions are among the genetic changes detected by the test. Those features supported the authorization of the IVD as a companion diagnostic for two cancer drugs, Bayer’s Vitrakvi and Lilly’s Retevmo.
Vitrakvi is authorized for use in patients with NTRK gene fusions. Retevmo is authorized for use in people with RET fusions. Physicians need to determine if a patient has the fusions before prescribing the drugs.
TSO Comprehensive joins the list of tests that doctors can use to identify patients who are eligible for treatment with the drugs. Roche’s Foundation Medicine received FDA authorization for a tissue-based Vitrakvi companion diagnostic in 2020. The company sells the same FoundationOne test to support the identification of patients eligible for Retevmo. Life Technologies also sells a diagnostic for Retevmo.
Illumina received a CE mark for TSO Comprehensive in 2022 and began offering the test to support the identification of patients in Europe who may benefit from Vitrakvi. While the test is tissue-based, Illumina used its strategy update earlier this month to outline the role its technology could play in supporting blood tests that enable therapy selection.
Illumina divested its own liquid biopsy unit Grail in June.
