FDA Approves Illumina's TruSight Oncology Assay, Elevating Cancer Diagnostics

The FDA has granted approval for Illumina's TruSight Oncology Comprehensive Assay, a groundbreaking in vitro diagnostic (IVD) kit designed for comprehensive genomic profiling (CGP) across various cancer types. This marks a significant milestone in cancer diagnostics, offering pan-cancer companion diagnostic claims, which allow clinicians to recommend personalized treatment strategies based on detailed molecular profiling. PreCheck Health Services is introducing this test under the name SolidTumorCheck+, bringing advanced cancer testing to community-based healthcare settings.

SolidTumorCheck+ profiles over 500 gene biomarkers, providing clinicians with valuable insights into the genetic alterations driving cancer. The test’s pan-cancer companion diagnostic capability enhances treatment precision by matching patients with targeted therapies based on their specific cancer profile. This advancement supports localized access to cutting-edge cancer diagnostics, reducing wait times for results and accelerating personalized care.

By offering SolidTumorCheck+, PreCheck Health Services strengthens its position as a leader in precision oncology, enabling faster diagnosis and access to advanced treatment options. This FDA-approved test is expected to revolutionize cancer care by expanding precision oncology services to a broader patient base.