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Illumina secures CMS reimbursement for TruSight™ Oncology Comprehensive, expanding access to precision oncology

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The FDA-approved comprehensive genomic profiling test will be reimbursed at a rate of $2,989.55 per ...

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Illumina has secured Medicare reimbursement for its TruSight Oncology test, set at $2,989.55 per test, starting January 1, 2026. This approval will likely boost adoption of genomic profiling in oncology, enhancing access to precision treatments for cancer patients and potentially driving revenue growth for Illumina in the clinical market.

Sentiment Rationale

Reimbursement for TSO Comprehensive enhances market access, likely leading to increased sales—a critical driver similar to past positive reimbursement announcements in biotech sectors.

Trading Thesis

ILMN is poised for upward momentum as market adoption of TSO Comprehensive increases post-reimbursement.

Market-Moving

  • Medicare reimbursement approval enhances the accessibility of genomic profiling.
  • Higher adoption rates of TSO Comprehensive could significantly boost Illumina's revenue.
  • Increased clinical market demand for genomic tests is expected to drive growth.
  • Potential partnerships with labs could expand TruSight's market reach.

Key Facts

  • Illumina's TruSight Oncology test receives Medicare reimbursement approval.
  • Reimbursement rate set at $2,989.55 per test enhances access to genomic profiling.
  • This decision facilitates precision oncology solutions for advanced cancer patients.
  • Illumina's clinical markets contributed significantly to revenue growth in 2025.
  • The test interrogates over 500 genes, aiding targeted therapy decisions.

Companies Mentioned

  • Bayer (BAYRY): Bayer's VITRAKVI is a therapy linked to TSO Comprehensive.
  • Eli Lilly (LLY): Lilly's RETEVMO targets a population identified by TSO Comprehensive.

Corporate Developments

This news falls under 'Corporate Developments' as it relates to a significant approval affecting Illumina's business strategy and market position. The reimbursement approval is crucial for expanding market share in the growing field of precision oncology.

Illumina Secures CMS Reimbursement for TruSight™ Oncology Comprehensive, Expanding Access to Precision Oncology

Illumina, Inc. (NASDAQ: ILMN) has achieved a significant milestone by securing reimbursement for its FDA-approved TruSight™ Oncology (TSO) Comprehensive test. The Centers for Medicare and Medicaid Services (CMS) has set the reimbursement rate at $2,989.55 per test, which will facilitate wider access to comprehensive genomic profiling (CGP) in the U.S. healthcare system, thereby enhancing personalized care for oncology patients.

Details of the Reimbursement Decision

The TSO Comprehensive test enables healthcare providers to assess hundreds of genes, including critical cancer biomarkers, which are essential for informed treatment decisions. The approval from CMS will allow more laboratories to incorporate CGP into their services, delivering actionable genomic insights closer to patients, thus bridging the gap between testing and clinical applications.

Effective January 1, 2026, TSO Comprehensive will be billed under the Clinical Laboratory Fee Schedule using Proprietary Laboratory Analysis (PLA) code 0543U, establishing a clear reimbursement pathway for Medicare beneficiaries.

Implications for Access to Precision Oncology

John Fox, MD, Senior Director of Market Access and Government Affairs at Illumina, stated, "This decision helps remove barriers that have limited adoption of comprehensive genomic profiling for patients, empowering more healthcare providers to deliver precision oncology insights that will improve outcomes." With increased reimbursement, healthcare networks, academic medical centers, hospitals, and regional reference laboratories will be better equipped to provide precision oncology diagnostics.

  • Reimbursement rate: $2,989.55
  • Effective date: January 1, 2026
  • PLA code: 0543U
  • Broader access to precision oncology solutions for advanced cancer patients

Growth in Clinical Markets

The demand for genomic testing is expanding across the healthcare ecosystem. Earlier this month, Illumina reported preliminary unaudited financials for the fourth quarter and fiscal year 2025, identifying clinical markets as a crucial growth driver. Approximately 60% of the company's sequencing consumables revenue came from clinical customers last year, illustrating the significant market potential.

About TruSight Oncology Comprehensive

The TSO Comprehensive test is a single FDA-approved diagnostic that interrogates more than 500 genes to profile solid tumors. This comprehensive genetic analysis enhances the chances of identifying immuno-oncology biomarkers which can direct targeted therapy selections or clinical trial enrollments.

Notably, TSO Comprehensive is approved as a companion diagnostic to pinpoint adult and pediatric patients with solid tumors that exhibit neurotrophic tyrosine receptor kinase (NTRK) gene fusions, who may benefit from Bayer's VITRAKVI® (larotrectinib). Additionally, it identifies adult patients with locally advanced or metastatic rearranged-during-transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC) suitable for treatment with Lilly's RETEVMO® (selpercatinib).

Forward-Looking Statements

This release may contain forward-looking statements involving risks and uncertainties. Key factors that could cause actual outcomes to differ materially include customer uptake of current products, satisfaction levels, and the ability to secure ongoing regulatory approvals and reimbursement from payors. These and other factors are detailed in Illumina's filings with the U.S. Securities and Exchange Commission.

About Illumina

Illumina is dedicated to improving human health by unlocking genomic potential. The company has established itself as a global leader in DNA sequencing and array-based technologies, serving diverse markets including research, clinical, and applied sciences. To learn more, visit illumina.com.

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