Illumina has secured an FDA approval to bring its pan-cancer tissue profiling test to U.S. shores.
A version of the company’s TruSight Oncology Comprehensive genomic diagnostic kit has been available in Europe since 2022. The test screens solid tumor samples for 517 different genes to uncover useful biomarker patterns that can identify patients who may benefit from specific immunotherapies.
That includes Bayer’s Vitrakvi (larotrectinib)—for adult and pediatric patients with certain NTRK mutations, regardless of their type of cancer—as well as Eli Lilly's Retevmo (selpercatinib) among people with RET fusion-positive non-small cell lung cancer (NSCLC). The latter is a new addition compared to the EU version of the test.
Those green lights, according to Illumina, make TSO Comprehensive the first FDA-approved, genomic in vitro diagnostic kit to carry pan-cancer companion diagnostic claims. The test, which runs on the company’s NextSeq 550Dx instrument, also provides measures of tumor mutational burden and other profiling information.
“FDA approval for TruSight Oncology Comprehensive with accompanying companion diagnostics marks an awaited milestone for our oncology customers and community,” Illumina’s chief commercial officer, Everett Cunningham, said in a statement.
NTRK gene fusions may only be found in about 0.1% to 0.3% of solid tumors and can be difficult to detect on top of that, Illumina said. By scanning RNA as well as DNA, the test can find multiple forms of the biomarker. Vitrakvi was one of the first pan-cancer therapies, garnering an FDA approval in 2018, but Bayer has at times struggled to find eligible patients for the targeted therapy.
At the same time, RET fusion-positive mutations occur in less than 2% of NSCLC cases. Retevmo has also shown gains in genomically related thyroid cancers, and the FDA expanded the drug’s indications in September 2022 to include all solid tumors presenting the RET biomarker—however, TSO Comprehensive’s companion diagnostic claims are limited to NSCLC.
Illumina said it “has a growing pipeline” of companion diagnostic claims currently under development, in collaboration with drugmakers, that it will seek in future regulatory submissions.