Illumina, a prominent company in the field of genomic sequencing, has recently received approval from the Food and Drug Administration (FDA) for its TruSight Oncology (TSO) Comprehensive test. This advanced genetic test is designed to analyze variants across 517 genes using nucleic acids extracted from solid tumor tissue samples. The test employs Illumina’s Nextseq 550Dx sequencing instrument to identify single nucleotide variants, multi-nucleotide variants, insertions, deletions, and more from DNA samples.
The FDA’s approval not only marks a significant milestone for Illumina but also includes authorization for the test to be used as a companion diagnostic for two specific cancer treatments: Bayer’s Vitrakvi and Eli Lilly’s Retevmo. These drugs are targeted therapies designed to treat cancers based on specific genetic alterations, and the TSO Comprehensive is now a recommended test to identify patients who may be eligible for these treatments.
Vitrakvi is used to treat patients who have cancers featuring NTRK gene fusions, and Retevmo is indicated for those with RET fusions. Therefore, the TSO Comprehensive test plays a crucial role in the diagnostic process by determining the presence of these fusions in the tumor tissue, which is a prerequisite for prescribing these targeted therapies.
This approval is particularly noteworthy following the success of Illumina’s TSO 500, a similar test that profiles 523 genes in tissue samples and generated sales exceeding $100 million in 2023. Illumina CEO Jacob Thaysen highlighted in a recent earnings call that this product is expected to continue experiencing significant growth.
Before receiving approval from the FDA, Illumina had already started marketing the TSO Comprehensive test in Europe, having secured a CE mark in 2022. The test has been available for assisting healthcare providers in identifying patients who may benefit from Vitrakvi in the European market.
In addition to its applications in tissue-based diagnostics, Illumina has outlined in its recent strategy update the potential for its technology to support blood tests that could also aid in therapy selection. This comes after Illumina decided to divest its liquid biopsy unit, Grail, in June, which suggests a strategic pivot focusing more intensely on its core genomic sequencing technologies.
Other companies, such as Roche’s Foundation Medicine and Life Technologies, have also received FDA approval for their diagnostic tests that detect similar genetic markers and support the identification of patients for treatments like Vitrakvi and Retevmo. This places Illumina’s TSO Comprehensive in a competitive market where multiple companies are providing essential diagnostic tools that guide the administration of precision medicines in oncology.
The FDA’s approval of the TSO Comprehensive test is a step forward for personalizing cancer treatment, providing physicians with a powerful tool to identify suitable candidates for targeted therapies based on genetic information derived directly from patients’ tumors. This is key to advancing treatment options and improving outcomes for patients with specific genetic profiles. Moreover, it reinforces Illumina’s position as a leader in genomic sequencing and its pivotal role in pushing the boundaries of how genetic data can be utilized in clinical settings.
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