The FDA has granted approval on Illumina's TruSight Oncology Comprehensive assay, marking a transformative milestone in cancer diagnostics. This innovative in vitro diagnostic (IVD) kit is the first of its kind, offering distributable comprehensive genomic profiling (CGP) with pan-cancer companion diagnostic claims.
The test is now available to patients and healthcare institutions in the USA via PreCheck Health Services, which has introduced the test under the name SolidTumorCheck+.
With the ability to process the TruSight Oncology Comprehensive assay, PreCheck Health Services can now provide patients with enhanced access to cutting-edge cancer treatments. This advancement enables rapid and detailed genomic profiling, helping clinicians deliver more targeted and personalised treatment strategies.
The FDA's approval of the TruSight Oncology Comprehensive test marks a significant leap forward for both medical professionals and patients. The test analyses over 500 gene biomarkers, supporting CGP across multiple cancer types. This detailed molecular profiling provides clinicians with actionable insights to recommend targeted therapeutic options, supported by two companion diagnostic claims.
TruSight Oncology Comprehensive is the first FDA-approved diagnostic kit designed to elevate cancer genomics. By profiling over 500 gene biomarkers, it aids in detecting cancer-driving genetic alterations across a variety of tumour types. Its standout feature is the pan-cancer companion diagnostic capability, which enables personalised therapy recommendations based on a patient's specific genomic profile.
The SolidTumorCheck+ test provides detailed genomic analysis across a broad spectrum of cancers, offering valuable insights into the molecular mechanisms driving the disease. It includes pan-cancer companion diagnostics, which further enhance its ability to match patients with specific therapies, providing a tailored approach to cancer treatment.
One of the most significant benefits of SolidTumorCheck+ is its potential to expand precision oncology services. By enabling PreCheck Health Services to process the assay locally, patients can receive advanced cancer care without the need to travel to major cancer centres.