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

Rhea-AI Summary

Illumina (NASDAQ: ILMN) announced that CMS will reimburse its FDA-approved TruSight™ Oncology Comprehensive (TSO Comprehensive) test at $2,989.55 per test under PLA code 0543U, effective January 1, 2026. The decision places TSO Comprehensive on the Clinical Laboratory Fee Schedule and establishes a predictable reimbursement pathway for Medicare beneficiaries. Illumina says broader reimbursement will enable more labs to provide in-house comprehensive genomic profiling (CGP) and expand access to precision oncology across hospitals, networks, and regional labs. Illumina also noted clinical markets drove growth, with ~60% of sequencing consumables revenue from clinical customers in 2025.

Positive

• CMS reimbursement set at $2,989.55 per TSO Comprehensive test
• Reimbursement effective Jan 1, 2026 under PLA code 0543U
• Predictable Medicare pathway for CGP may increase test adoption
• ~60% of sequencing consumables revenue came from clinical customers in 2025

Negative

• None.

News Market Reaction

+3.90%

1 alert

+3.90% News Effect

On the day this news was published, ILMN gained 3.90%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

CMS reimbursement rate: $2,989.55 per test Reimbursement effective date: January 1, 2026 Clinical consumables mix: 60% +1 more

4 metrics

CMS reimbursement rate $2,989.55 per test TSO Comprehensive under Clinical Laboratory Fee Schedule using PLA code 0543U

Reimbursement effective date January 1, 2026 Effective date for TSO Comprehensive CMS reimbursement

Clinical consumables mix 60% Share of sequencing consumables revenue from clinical customers in last year

PLA code 0543U Proprietary Laboratory Analysis billing code for TSO Comprehensive

Market Reality Check

Price: $152.09 Vol: Volume 1,893,546 is modes...

normal vol

$152.09 Last Close

Volume Volume 1,893,546 is modestly above 20-day average 1,704,714 (relative volume 1.11). normal

Technical Price 141.65 is trading above 200-day MA at 101.99 and 6.4% below the 52-week high of 151.34.

Peers on Argus

ILMN was down 2.51% while peers were mixed: WAT -1.04%, MEDP -1.16%, DGX +0.05%,...

ILMN was down 2.51% while peers were mixed: WAT -1.04%, MEDP -1.16%, DGX +0.05%, LH +1.42%, PKI flat. Moves do not indicate a unified sector direction.

Historical Context

5 past events · Latest: Jan 13 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 13	AI data platform	Positive	+1.0%	Launch of Billion Cell Atlas to support AI-driven drug discovery.
Jan 13	Prelim earnings	Positive	+1.0%	Preliminary Q4 and FY 2025 revenue and EPS update.
Jan 12	Earnings date set	Positive	+3.2%	Announcement of Feb 5, 2026 earnings release and call details.
Jan 08	Leadership change	Neutral	-3.3%	New Chief Medical Officer and chief commercial officer departure.
Jan 06	Software launch	Positive	+4.1%	Launch of cloud-based Connected Multiomics analysis platform.

Pattern Detected

Recent innovation and data-platform announcements have generally coincided with positive price reactions, while management changes drew a negative response.

Recent Company History

Over the past weeks, Illumina reported preliminary unaudited FY 2025 results, launched Illumina Connected Multiomics software, and introduced the Billion Cell Atlas AI dataset, all followed by modestly positive stock reactions. An 8-K on a chief commercial officer departure coincided with a decline. Today’s CMS reimbursement for the FDA-approved TSO Comprehensive test continues the theme of expanding clinical and precision oncology offerings within the US healthcare system.

Market Pulse Summary

This announcement secures CMS reimbursement for Illumina’s FDA-approved TSO Comprehensive test at $2...

Analysis

This announcement secures CMS reimbursement for Illumina’s FDA-approved TSO Comprehensive test at $2,989.55 per use under PLA code 0543U, giving laboratories a clear Medicare payment pathway from January 1, 2026. It reinforces Illumina’s clinical focus, with clinical customers driving roughly 60% of sequencing consumables revenue last year. Investors may watch adoption trends, mix of clinical versus research revenue, and subsequent updates on precision oncology product traction.

Key Terms

comprehensive genomic profiling, precision oncology, in vitro diagnostic (ivd), biomarkers, +2 more

6 terms

comprehensive genomic profiling medical

"The reimbursement decision from the Centers for Medicare and Medicaid Services (CMS) will expand access to comprehensive genomic profiling (CGP)..."

Comprehensive genomic profiling is a laboratory test that reads a large portion of a tumor’s or patient’s DNA to find many possible genetic changes at once, like using a detailed map instead of a single street view. For investors, it matters because results can guide targeted treatments, influence demand for companion diagnostics and drugs, and affect regulatory approvals and reimbursement, all of which can drive clinical adoption and commercial value.

precision oncology medical

"expand access to comprehensive genomic profiling (CGP) and the growing role of personalized genomics in oncology care."

Precision oncology uses detailed biological information from a patient’s tumor—like genetic changes or specific markers—to choose treatments most likely to work for that individual, much like tailoring a suit to a person’s measurements instead of selling one-size-fits-all clothing. It matters to investors because these targeted approaches can improve treatment success, support premium pricing and companion diagnostic tests, and shorten development and approval timelines, creating focused markets with both higher potential returns and specialized risks.

in vitro diagnostic (ivd) medical

"reimbursement has been granted for its FDA-approved in vitro diagnostic (IVD) TruSight™ Oncology (TSO) Comprehensive test."

In vitro diagnostic (IVD) tests are medical tests run on samples such as blood, urine or swabs outside the body to detect diseases, measure biomarkers or guide treatment decisions. Investors pay attention because IVDs generate recurring sales for test kits and instruments, are heavily influenced by regulatory approval, reimbursement and accuracy, and can quickly shift market value when a test becomes widely adopted or replaced — like a trusted household tool that professionals rely on every day.

biomarkers medical

"assess hundreds of genes—including relevant cancer biomarkers—to inform treatment decisions."

Biomarkers are measurable indicators found in the body, such as substances in blood or tissues, that reveal information about health or disease. For investors, they can signal how well a medical treatment is working or whether a disease is developing, helping to assess the potential success or risks of healthcare companies or innovations. Think of biomarkers as biological signals that provide clues about a person’s health status.

clinical laboratory fee schedule financial

"TSO Comprehensive is reimbursed under the Clinical Laboratory Fee Schedule at a rate of $2,989.55..."

A clinical laboratory fee schedule is a set list of prices that a payer—such as a government program or insurance company—will reimburse for specific lab tests and services. Think of it as a menu of allowed payments that determines how much labs can charge and get paid; changes to those prices directly affect a lab’s revenue, profit margins and investment prospects because lower rates squeeze earnings while higher rates improve cash flow.

proprietary laboratory analysis (pla) code financial

"using Proprietary Laboratory Analysis (PLA) code 0543U, which establishes a clear and predictable reimbursement pathway..."

A proprietary laboratory analysis (PLA) code is a unique identifier assigned to a specific lab-developed test that lacks a standard billing code, similar to giving a product its own SKU so it can be tracked and billed. Investors care because a PLA code helps laboratories and payers identify, price and reimburse a diagnostic test, which can accelerate commercial adoption and revenue recognition for companies that develop the test.

AI-generated analysis. Not financial advice.

The FDA-approved comprehensive genomic profiling test will be reimbursed at a rate of $2,989.55 per test, helping to advance adoption in the US healthcare system

SAN DIEGO, Jan. 20, 2026 /PRNewswire/ -- Illumina, Inc. (NASDAQ: ILMN) today announced that reimbursement has been granted for its FDA-approved in vitro diagnostic (IVD) TruSight™ Oncology (TSO) Comprehensive test. The reimbursement decision from the Centers for Medicare and Medicaid Services (CMS) will expand access to comprehensive genomic profiling (CGP) and the growing role of personalized genomics in oncology care.

"This decision helps removes barriers that have limited adoption of comprehensive genomic profiling for patients, empowering more healthcare providers to deliver precision oncology insights that will improve outcomes," said John Fox, MD, senior director, Market Access and Government Affairs at Illumina. 

TSO Comprehensive gives clinicians the ability to simultaneously assess hundreds of genes—including relevant cancer biomarkers—to inform treatment decisions. With reimbursement now in place, more laboratories will be able to bring CGP in-house and deliver clinically actionable results to their patients, closer to the point of care.

TSO Comprehensive enables laboratories of all sizes to deliver FDA-approved, clinically valuable genomic insights that are easy to access and implement.  This promotes broader access to precision oncology diagnostics across academic medical centers, healthcare networks, hospitals, and regional reference laboratories.

Effective January 1, 2026, TSO Comprehensive is reimbursed under the Clinical Laboratory Fee Schedule at a rate of $2,989.55 using Proprietary Laboratory Analysis (PLA) code 0543U, which establishes a clear and predictable reimbursement pathway for all Medicare beneficiaries.

Advancing clinical genomics across the healthcare ecosystem

Clinical demand for genomic testing is growing at every level of the health care ecosystem. With that demand comes opportunity for better health care and improved quality of life by advancing access to and adoption of tests like TSO Comprehensive. 

Earlier this month, Illumina reported preliminary unaudited financials for the fourth quarter and fiscal year 2025, which highlighted clinical markets as a key driver of growth. Roughly 60% of the company's sequencing consumables revenue was driven by clinical customers last year.

About TruSight Oncology Comprehensive

TruSight Oncology Comprehensive is a single FDA-approved test that interrogates more than 500 genes to profile a patient's solid tumor, helping increase the likelihood of identifying immuno-oncology or other clinically actionable biomarkers that can guide targeted therapy selection or clinical trial enrollment.

TSO Comprehensive is approved as a companion diagnostic (CDx) to identify adult and pediatric patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions and may benefit from treatment with Bayer's VITRAKVI® (larotrectinib). The test is also approved to identify adult patients with locally advanced or metastatic rearranged-during-transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC) who may benefit from treatment with Lilly's RETEVMO® (selpercatinib).

Use of forward-looking statements

This release may contain forward-looking statements that involve risks and uncertainties. Among the important factors to which our business is subject that could cause actual results to differ materially from those in any forward-looking statements are: (i) customer uptake of, and satisfaction with, new and existing products and services; and (ii) our ability to obtain or maintain regulatory approval for our products from government agencies and reimbursement from payors, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts' expectations, or to provide interim reports or updates on the progress of the current quarter.

About Illumina 

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit illumina.com and connect with us on X, Facebook, LinkedIn, Instagram, TikTok, and YouTube. 

Investors:
Illumina Investor Relations
858-291-6421
IR@illumina.com

Media:
Christine Douglass
PR@illumina.com

 

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SOURCE Illumina, Inc.

FAQ

What reimbursement rate did CMS assign to Illumina's TSO Comprehensive (ILMN) and when does it take effect?

CMS reimburses TSO Comprehensive at $2,989.55 per test, effective January 1, 2026.

Under which PLA code is Illumina's TruSight Oncology Comprehensive reimbursed for Medicare beneficiaries (ILMN)?

TSO Comprehensive is reimbursed under PLA code 0543U on the Clinical Laboratory Fee Schedule.

How could CMS reimbursement for TSO Comprehensive affect Illumina's adoption in clinical labs (ILMN)?

Reimbursement creates a clear Medicare payment pathway, which may enable more labs to bring FDA-approved CGP in-house and broaden clinical access.

What portion of Illumina's sequencing consumables revenue came from clinical customers in 2025 (ILMN)?

Illumina reported that roughly 60% of sequencing consumables revenue was driven by clinical customers in 2025.

Will CMS reimbursement for TSO Comprehensive apply to all Medicare beneficiaries (ILMN)?

Yes; listing on the Clinical Laboratory Fee Schedule establishes reimbursement for Medicare beneficiaries under the specified PLA code.