FDA has approved Illumina for its TruSight Oncology Comprehensive Assay, a groundbreaking in vitro diagnostic (IVD) kit.
This approval marked a significant milestone in cancer diagnostics as it is the first to offer distributable comprehensive genomic profiling (CGP) with pan-cancer companion diagnostic claims.
The TruSight Oncology Comprehensive Assay is the first FDA-approved IVD kit for identifying NTRK-positive solid tumors in adult and pediatric patients, potentially benefiting from larotrectinib (Vitrakvi) treatment.
The assay also received FDA approval as a companion diagnostic for identifying adult patients with locally advanced or metastatic RET fusion-positive non-small cell lung cancer (NSCLC) who may benefit from selpercatinib (Retevmo) treatment.
PreCheck Health Services was enthusiastic about introducing this test under SolidTumorCheck+, signaling a significant advancement in precision oncology and patient care.
By offering the TruSight Oncology Comprehensive Assay, PreCheck Health Services aimed to enhance patient access to advanced cancer treatments by providing rapid and detailed genomic profiling, enabling clinicians to deliver more personalized treatment strategies.
Source: FDA Approves Illumina’s TruSight Oncology Comprehensive Assay, Now Offered by PreCheck Health Services as “SolidTumorCheck+” — A Breakthrough in Precision Oncology
https://www.prnewswire.com/news-releases/fda-approves-illuminas-trusight-oncology-comprehensive-assay-now-offered-by-precheck-health-services-as-solidtumorcheck–a-breakthrough-in-precision-oncology-302241197.html
