FDA approves Illumina cancer biomarker test with two companion diagnostics to rapidly match patients to targeted therapies

Rhea-AI Summary

Illumina (NASDAQ: ILMN) has received FDA approval for its TruSight Oncology (TSO) Comprehensive test, a 500+ gene biomarker test for solid tumors. This in vitro diagnostic (IVD) kit is the first FDA-approved, distributable comprehensive genomic profiling test with pan-cancer companion diagnostic claims. It includes two companion diagnostic (CDx) indications:

1. Identifying patients with NTRK gene fusions for treatment with Bayer's VITRAKVI (larotrectinib)
2. Detecting RET fusion-positive non-small-cell lung cancer (NSCLC) patients for treatment with Lilly's RETEVMO (selpercatinib)

The test aims to improve access to localized precision oncology and increase the chances of finding actionable biomarkers. TSO Comprehensive will begin shipping to customers this year and is reimbursable under CMS national coverage determination.

Positive

• FDA approval of TruSight Oncology Comprehensive test with two companion diagnostic indications
• First FDA-approved, distributable comprehensive genomic profiling IVD kit with pan-cancer CDx claims
• Test interrogates over 500 genes to profile solid tumors
• Approved for use across solid tumor indications for NTRK CDx
• Reimbursable under CMS national coverage determination
• Growing pipeline of CDx claims under development through pharmaceutical partnerships

Negative

• None.

Insights

Medical Research Analyst

The FDA approval of Illumina's TruSight Oncology Comprehensive test is a significant advancement in precision oncology. This 500+ gene biomarker test offers a comprehensive genomic profiling solution with pan-cancer companion diagnostic capabilities. The test's ability to interrogate both DNA and RNA allows for the identification of a wide range of known and novel gene fusions, particularly important for detecting rare NTRK gene fusions (0.1-0.3% across solid tumors).

The approval of two companion diagnostic indications for NTRK and RET fusions is particularly noteworthy. This enables rapid matching of patients to targeted therapies like VITRAKVI and RETEVMO, potentially improving treatment outcomes. The test's broad applicability across solid tumor types could streamline the diagnostic process and increase the chances of finding actionable genetic information from a single biopsy.

Financial Analyst

Illumina's FDA approval for TSO Comprehensive represents a significant market opportunity. The test's reimbursement eligibility under CMS national coverage determination is a important factor for commercial success. With the growing emphasis on precision medicine, this approval positions Illumina to capture a larger share of the oncology diagnostics market.

The company's partnerships with pharmaceutical giants like Bayer and Lilly for companion diagnostics development indicate potential for future revenue streams. As Illumina expands its CDx pipeline, it could see increased adoption of its sequencing platforms in clinical settings. Investors should note the potential for long-term growth as more targeted therapies enter the market, driving demand for comprehensive genomic profiling tests.

Oncology Expert

The approval of TSO Comprehensive is a game-changer for oncology practice. Its ability to profile over 500 genes in a single test can significantly reduce time-to-treatment and improve patient outcomes. The test's pan-cancer approach, especially for NTRK fusions, addresses the challenge of identifying rare but actionable genetic alterations across various tumor types.

For NSCLC patients, the RET fusion detection capability is particularly valuable, given its occurrence in up to 2% of cases. The test's comprehensive nature, including assessment of tumor mutational burden and emerging biomarkers, provides oncologists with a powerful tool for treatment decision-making. This approval aligns with the growing trend towards personalized cancer care and could potentially reduce the need for multiple, sequential diagnostic tests.

• TruSight Oncology Comprehensive is the first US FDA-approved, distributable comprehensive genomic profiling IVD kit with pan-cancer companion diagnostic claims
• The 500+ gene biomarker test advances access to localized precision oncology for patients

SAN DIEGO, Aug. 27, 2024 /PRNewswire/ -- Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced Food and Drug Administration (FDA) approval of its in vitro diagnostic (IVD) TruSight™ Oncology (TSO) Comprehensive test and its first two companion diagnostic (CDx) indications. This single test interrogates over 500 genes to profile a patient's solid tumor, helping to increase the likelihood of identifying an immuno-oncology biomarker or clinically actionable biomarkers that enable targeted therapy options or clinical trial enrollment. 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). 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 Lilly's RETEVMO^® (selpercatinib).

"FDA approval for TruSight Oncology Comprehensive with accompanying companion diagnostics marks an awaited milestone for our oncology customers and community," said Everett Cunningham, chief commercial officer of Illumina. "We are committed to partnering with industry leaders like Bayer and Lilly to advance cancer diagnostics and help broaden access to precision oncology for more patients."

A CDx test may identify 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 therapy. Most CDx tests are specific to one type of cancer, but TSO Comprehensive is approved for use across solid tumor indications for the NTRK CDx, helping to maximize the chances of finding actionable information from each patient's biopsy.

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 also interrogates RNA and thus can identify a broad range of known and novel gene fusion partners across all three NTRK gene fusions, NTRK1, NTRK2, and NTRK3.  Bayer's VITRAKVI (larotrectinib) is a highly selective TRK inhibitor approved for use in patients with TRK fusion cancer, in accordance with therapeutic labeling.

NSCLC is one of the most common types of lung cancer and the leading cause of cancer-related deaths globally. The expansive actionable biomarker landscape in NSCLC has driven the need for broad molecular profiling to enable a complete view of a patient's disease to better 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. Lilly's RETEVMO (selpercatinib) is a highly selective and potent RET kinase inhibitor in locally advanced or metastatic NSCLC. 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.

"Through research conducted globally, there is a significant body of evidence demonstrating the clinical utility of comprehensive genomic profiling for patients with advanced cancer," said Vivek Subbiah, MD, chief, Early-Phase Drug Development at Sarah Cannon Research Institute. "Illumina's newest distributable IVD kit for comprehensive genomic profiling and accompanying CDx enable another valuable clinical tool for the oncology community to match patients with targeted therapies that can vastly improve their journey and outcomes."

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

Illumina has a growing pipeline of CDx claims under development 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 make a difference in the lives of patients with cancer.

A separate CE-marked version of TSO Comprehensive is already available in Europe, launched in 2022. To learn more about TruSight Oncology Comprehensive, click here.  

About TruSight Oncology Comprehensive

TruSight Oncology Comprehensive is a qualitative in vitro diagnostic test that uses targeted next-generation sequencing to detect variants in 517 genes using nucleic acids extracted from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from cancer patients with solid malignant neoplasms using the Illumina^® NextSeq™ 550Dx Instrument. The test can be used to detect single nucleotide variants, multi-nucleotide variants, insertions, and deletions from DNA, and fusions in 24 genes and splice variants in one gene from RNA. The test also reports a Tumor Mutational Burden (TMB) score.

The test is intended to be used as a companion diagnostic to identify cancer patients who may benefit from treatment with the targeted therapies listed in Table 1, in accordance with the approved therapeutic product labeling.

In addition, the test is intended to provide tumor profiling information for use by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Genomic findings other than those listed in Table 1 of the intended use statement are not conclusive or prescriptive for labeled use of any specific therapeutic product.

Table 1: Companion diagnostic indications

Tumor Type	Biomarker(s) Detected	Therapy
Solid Tumors	NTRK1/2/3 fusions	VITRAKVI® (larotrectinib)
Non-Small Cell Lung Cancer	RET fusions	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) our ability to manufacture robust instrumentation and consumables; (ii) challenges inherent in developing, manufacturing, and launching new products and services; (iii) our ability to obtain or maintain regulatory approval for our products from government agencies and reimbursement from payors; (iv) our ability to successfully partner with other companies and organizations to develop new products, expand markets, and grow our business, 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.

Contacts

Investors:
Salli Schwartz
858-291-6421
IR@illumina.com

Media:
Samantha Beal
PR@illumina.com

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SOURCE Illumina, Inc.

FAQ

What is the TruSight Oncology Comprehensive test by Illumina (ILMN)?

TruSight Oncology Comprehensive is an FDA-approved in vitro diagnostic test that profiles over 500 genes in solid tumors. It's the first distributable comprehensive genomic profiling IVD kit with pan-cancer companion diagnostic claims, designed to help match patients with targeted cancer therapies.

What are the two companion diagnostic indications for Illumina's (ILMN) TSO Comprehensive test?

The two companion diagnostic indications are: 1) Identifying patients with NTRK gene fusions for treatment with Bayer's VITRAKVI (larotrectinib), and 2) Detecting RET fusion-positive non-small-cell lung cancer (NSCLC) patients for treatment with Lilly's RETEVMO (selpercatinib).

When will Illumina (ILMN) start shipping the TSO Comprehensive test to customers?

Illumina will begin shipping the TruSight Oncology Comprehensive test to customers in 2024, following its FDA approval announced on August 27, 2024.

Is Illumina's (ILMN) TSO Comprehensive test reimbursable?

Yes, the TruSight Oncology Comprehensive test is reimbursable under a Centers for Medicare & Medicaid Service (CMS) national coverage determination for comprehensive genomic profiling assays with companion diagnostic claims for solid tumors.