Illumina plans to make TSO Comprehensive available to customers this year for targeted cancer therapy. Credit: skipper_sr / Shutterstock.

Illumina has secured approval from the US Food and Drug Administration (FDA) for its TruSight Oncology (TSO) Comprehensive test and its two companion diagnostics (CDx) indications.

TSO Comprehensive is authorised as a CDx to help determine whether adults and pediatric patients will benefit from treatment with Bayer‘s Vitrakvi (larotrectinib) when neurotrophic tyrosine receptor kinase (NTRK) gene fusions are detected in solid tumours.

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The vitro diagnostic test is also approved to determine adult patients with locally advanced or metastatic rearranged during transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC). These patients may benefit from Lilly’s Retevmo (selpercatinib) treatment.

Illumina chief commercial officer Everett Cunningham said: “FDA approval for TruSight Oncology Comprehensive with accompanying companion diagnostics marks an awaited milestone for our oncology customers and community.

“We are committed to partnering with industry leaders like Bayer and Lilly to advance cancer diagnostics and help broaden access to precision oncology for more patients.”

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The biomarker test profiles over 500 genes in solid tumours to identify immuno-oncology or clinically actionable biomarkers and match patients with targeted therapies.

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Illumina’s TSO Comprehensive will be available to customers this year and is reimbursable under Medicare and Medicaid for solid tumours.

The company is expanding its CDx pipeline through pharmaceutical partnerships, aiming to enhance TSO Comprehensive with additional regulatory-approved claims.

In June 2024, Illumina announced the completion of its spin-off of cancer test maker Grail.

The separation from Grail was achieved by distributing 85.5% of Grail’s shares to Illumina’s shareholders.

Each Illumina shareholder received one Grail share for every six Illumina shares owned while retaining their Illumina shares.