ILMN's TSO Comprehensive IVD Test Secures FDA Approval as CDx

Illumina, Inc. ILMN has secured the FDA's approval for its in vitro diagnostic (IVD) TruSight Oncology Comprehensive test and first two companion diagnostic (CDx) indications. The test analyses more than 500 genes to profile a patient's solid tumor, improving the chances of identifying an immuno-oncology or clinically actionable biomarkers that enable targeted therapy options or clinical trial enrollment.

The latest development marks a long-awaited milestone for the company's oncology customers and community. In Europe, a separate CE-marked version of TSO Comprehensive has been available since its launch in 2022. 

Role of ILMN's TSO Comprehensive Test as a CDx

A CDx test can reveal whether a patient's tumor has a specific gene change or biomarker that can be targeted by a therapy, helping to determine if a patient should receive the treatment. Illumina's TSO Comprehensive is FDA-approved as a CDx to identify adult and pediatric patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions that may benefit from treatment with Bayer's VITRAKVI (larotrectinib). VITRAKVI is a highly selective TRK inhibitor approved for use in patients with TRK fusion cancer, in accordance with therapeutic labeling.

NTRK gene fusions are rare across most solid cancer tumor types (~0.1%–0.3%) and can be challenging to detect, given that these genes can fuse with different partners, many of which were previously unknown. TSO Comprehensive interrogates ribonucleic acid and can identify a broad range of known and novel gene fusion partners across all three NTRK gene fusions, NTRK1, NTRK2 and NTRK3.

Most CDx tests are specific to one type of cancer, however, TSO Comprehensive is approved for use across solid tumor indications for the NTRK CDx. This helps to maximize the chances of finding actionable information from each patient's biopsy.

Importance of ILMN's TSO Comprehensive in NSCLC Treatment

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) that may benefit from treatment with Eli Lilly's RETEVMO (selpercatinib) — a highly selective and potent RET kinase inhibitor in locally advanced or metastatic NSCLC.

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As one of the most common types of lung cancer and the leading cause of cancer-related deaths globally, NSCLC has an expansive actionable biomarker landscape. This has driven the need for broad molecular profiling to better understand the patient's disease and guide clinical management. The oncogenic activation of RET fusion-positive NSCLC by gene fusions is a primary driver in NSCLC, occurring in up to 2% of cases.

TSO Comprehensive enables broad characterization and simultaneous detection of multiple prognostic and predictive biomarkers such as RET, genomic signatures such as tumor mutational burden and emerging biomarkers within NSCLC in a single test.

Collaborations Boost Illumina's Cancer Efforts

Illumina's partnerships with industry leaders like Bayer and Lilly are crucial to advancing cancer diagnostics and expanding access to precision oncology for more patients. The company is developing a pipeline of CDx claims through partnerships with pharmaceutical companies, which will be added to TSO Comprehensive following appropriate regulatory approvals. These CDx claims will help unlock groundbreaking targeted therapies and immunotherapies to benefit cancer patients.

TSO Comprehensive will start shipping to customers this year. Comprehensive genomic profiling assays with CDx claims for solid tumors, like TSO Comprehensive, are reimbursable under Centers for Medicare & Medicaid Service national coverage determination.

Industry Prospects Favors Illumina

Per a Grand View Research report, the global oncology CDx market was valued at $4.78 billion in 2023 and projected to grow at a compound annual growth rate (CAGR) of 8.7% by 2030.

The market is growing due to the increasing prevalence of cancer, the growing adoption of CDx and a rising emphasis on personalized medicine. The need for early cancer detection tests, which can help improve disease management & reduce mortality, is expected to propel the overall market growth.

Illumina's Recent Developments

Earlier this month, the company expanded its oncology menu for the NovaSeq X Series customers with the high-throughput version of TruSight Oncology 500 and the latest version of its distributed liquid biopsy research assay, TruSight Oncology 500 ctDNA v2. These assays enable labs to confidently expand oncology testing research of tissue and liquid biopsy samples, with new transformative sequencing economics, faster sequencing run times and broader batch sizes on the NovaSeq X Series for the first time.

ILMN Stock Price, Consensus and EPS Surprise

In the past year, ILMN shares have lost 17.2% compared with the industry's decline of 2.3%.

In the past 30 days, Illumina's 2024 estimated earnings have surged nearly 94% to $3.16 per share. The stock has beat estimates in each of the trailing four quarters, the average surprise being 463.5%.

ILMN's Zacks Rank and Other Top MedTech Stocks

Illumina currently sports a Zacks Rank #1 (Strong Buy).

Some other top-ranked stocks in the broader medical space are Exact Sciences EXAS, Boston Scientific and SiBone SIBN, each carrying a Zacks Rank #2 (Buy) at present.

Exact Sciences' shares have lost 25.2% in the past year. Estimates for the company's loss per share have improved from $1.09 to 95 cents in 2024 and from 26 cents to 6 cents in 2025 in the past 30 days. EXAS' earnings beat estimates in three of the trailing four quarters and matched in one, delivering an average surprise of 56.2%. In the last reported quarter, it posted an earnings surprise of 75.7%.

Estimates for Boston Scientific's 2024 earnings per share have moved to $2.40 from $2.36 in the past 30 days. Shares of the company have gained 48.1% in the past year compared with the industry's growth of 13.9%. BSX's earnings surpassed estimates in each of the trailing four quarters, the average surprise being 7.2%. In the last reported quarter, it delivered an earnings surprise of 6.9%.

Estimates for SiBone's 2024 loss per share have narrowed to 89 cents from 95 cents in the past 30 days. Shares of the company have lost 23% in the past year against the industry's 11.4% growth. SIBN's earnings surpassed estimates in each of the trailing four quarters, the average surprise being 13.4%. In the last reported quarter, it delivered an earnings surprise of 15.4%.

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