Illumina Gets CE-IVD Mark for its ‘Pan-Cancer’ TruSight Companion Diagnostic

Illumina has gained CE-IVD certification as a companion diagnostic for its TruSight oncology comprehensive test to assess cancer patients for treatment with Bayer's Vitrakvi (larotrectinib).

The test uses a single biopsy specimen to assess multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer. The companion diagnostic can identify patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions and may benefit from targeted therapy with Vitrakvi.  

San Diego, Calif.-based Illumina, which specializes in DNA sequencing and array-based technologies, is already marketing the test in Europe.