#USA #San Diego #Illumina #CMS #TruSight Oncology

Illumina's Major Breakthrough in Cancer Genomics

Illumina, Inc. has announced a significant advancement for precision oncology with the approval of reimbursement for its FDA-approved TruSight™ Oncology Comprehensive test from the Centers for Medicare and Medicaid Services (CMS). This pivotal decision opens the doors to broader access for patients needing comprehensive genomic profiling (CGP), a vital component in personalized cancer care.

Understanding TruSight™ Oncology Comprehensive

TruSight™ Oncology Comprehensive is an in vitro diagnostic test designed to provide insights into the genetic makeup of a patient's solid tumor. The test examines over 500 genes, helping clinicians identify relevant biomarkers that can guide treatment decisions and improve patient outcomes. As of January 1, 2026, these tests will be reimbursed at a rate of $2,989.55 under the Clinical Laboratory Fee Schedule, utilizing the Proprietary Laboratory Analysis (PLA) code 0543U. This reimbursement path is expected to alleviate previously encountered barriers and foster increased adoption within the healthcare system.

According to John Fox, MD, senior director of Market Access and Government Affairs at Illumina, “This decision not only diminishes obstacles that have hindered the uptake of comprehensive genomic profiling but also empowers healthcare providers. It enhances their ability to deliver precise oncology insights that significantly improve patient outcomes.”

Expanding Access Across the Healthcare System

With this reimbursement, laboratories, irrespective of their size, can now offer this crucial genomic profiling test. It promotes greater accessibility to precise oncology diagnostics across hospitals, healthcare networks, academic medical centers, and regional reference laboratories. The widespread availability of TSO Comprehensive will facilitate timely, clinically actionable results, which are essential for informed treatment planning in oncology.

The growing need for genomic testing across healthcare circles is driven by an increasing understanding of personalized medicine. As genomic science continues to evolve, the adoption of tests like TSO Comprehensive is seen as an integral part of enhancing patient care and quality of life. Illumina reported that approximately 60% of its sequencing consumables revenue in the previous year originated from clinical customers, emphasizing the rising significance of genomic testing in clinical settings.

The Importance of CGP in Oncology

TruSight Oncology Comprehensive plays a crucial role in identifying actionable biomarkers, thereby increasing the likelihood of treating patients effectively. Beyond its primary use, the test is approved as a companion diagnostic (CDx) for therapies targeting specific genetic alterations. For instance, it helps detect neurotrophic tyrosine receptor kinase (NTRK) gene fusions, facilitating the appropriate use of Bayer’s VITRAKVI® (larotrectinib) in patients. Additionally, it also identifies patients with rearranged-during-transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC) who might benefit from Lilly’s RETEVMO® (selpercatinib).

Looking Toward the Future

Illumina’s TruSight™ Oncology Comprehensive is positioned to become increasingly vital within the evolving landscape of personalized healthcare, making significant strides toward optimizing patient outcomes in oncology. As healthcare providers become more equipped to integrate genomic insights into treatment protocols, the potential for improved survival rates and quality of life for cancer patients may heighten.

In summary, the strategic move by CMS to include reimbursement for TruSight™ Oncology Comprehensive is not only a win for Illumina but a transformative achievement for patients across the United States. It signals a shift towards greater integration of genomic sciences in routine clinical practice, paving the way for innovations in cancer treatment and management. With continued focus and investment in genomic technologies, the future for oncology care looks promising as it heads towards a more personalized model of treatment.