FDA Approves Illumina Cancer Test with Two Companion Diagnostics for Rapid Therapy Matching

Illumina, Inc., a prominent global entity in DNA sequencing and array-based technologies, announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its groundbreaking in vitro diagnostic (IVD) test, TruSight™ Oncology (TSO) Comprehensive. This advanced test, which profiles over 500 genes, is designed to support precision oncology by evaluating solid tumors and identifying critical biomarkers. The FDA approval also encompasses two specific companion diagnostic (CDx) indications, making it a vital tool for personalized cancer treatment.

TSO Comprehensive is notable for its ability to interrogate an extensive range of genes, which significantly enhances the possibility of discovering immuno-oncology biomarkers or other clinically actionable markers. These discoveries are critical as they enable tailored therapy options for patients or facilitate their enrollment in relevant clinical trials. By advancing genomic profiling through this test, Illumina aims to broaden access to localized precision oncology, ensuring that patients receive the most effective, individualized treatment based on the unique characteristics of their tumors.

One of the key features of TSO Comprehensive is its FDA-approved role as a companion diagnostic. It is particularly approved for identifying adult and pediatric patients with solid tumors that exhibit neurotrophic tyrosine receptor kinase (NTRK) gene fusions. Patients with these gene fusions might benefit from treatment with Bayer’s VITRAKVI® (larotrectinib), a targeted therapy known for its efficacy in treating cancers driven by NTRK gene fusions. This approval represents a significant step forward in providing targeted treatment options for a wider range of cancer patients, including children.

Additionally, TSO Comprehensive is approved for identifying adult patients with locally advanced or metastatic rearranged during transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC). Such patients may benefit from treatment with Lilly's RETEVMO® (selpercatinib), an established therapy for RET fusion-positive cancers. The inclusion of these specific companion diagnostics extends the test’s utility, ensuring that it can rapidly match patients to suitable therapies based on their unique genetic profiles.

The approval of TSO Comprehensive underscores the advancing field of precision oncology, where the goal is to provide tailored treatments that align closely with the genetic makeup of an individual's cancer. This approach contrasts with traditional methods that may rely on a more generalized treatment regimen, often leading to less effective outcomes. By focusing on the unique genetic alterations present in a patient’s tumor, TSO Comprehensive enables more precise targeting of cancer therapies, potentially improving response rates and outcomes.

Illumina’s announcement marks a significant milestone in the availability of advanced genomic profiling tools. The company's commitment to enhancing cancer care through innovative technologies is evident in the development and FDA approval of TSO Comprehensive. This test not only supports the identification of vital biomarkers but also aligns with the broader movement towards personalized medicine, where treatments are increasingly customized to fit the genetic profiles of individual patients.

In summary, the FDA approval of TruSight Oncology Comprehensive is a transformative development in the field of genomics and oncology. By enabling extensive gene profiling and supporting targeted therapy options, this test represents a significant leap forward in the quest to provide more effective, personalized cancer treatments.