SAN DIEGO - Illumina, Inc. (NASDAQ: ILMN), a pioneer in DNA sequencing technology, announced the approval of its TruSight Oncology Comprehensive test by the U.S. Food and Drug Administration (FDA). This in vitro diagnostic (IVD) kit, capable of profiling over 500 genes, aims to facilitate precision oncology by identifying immuno-oncology biomarkers and clinically actionable biomarkers for solid tumors, which could lead to targeted therapy options or clinical trial enrollment.
The FDA-approved test serves as a companion diagnostic (CDx) to identify patients with solid tumors who may benefit from specific treatments like Bayer (OTC:BAYRY)'s VITRAKVI (larotrectinib) for neurotrophic tyrosine receptor kinase (NTRK) gene fusions and Lilly's RETEVMO (selpercatinib) for non-small-cell lung cancer (NSCLC) with RET fusions. These approvals highlight the test's potential to guide therapy for a range of solid tumor indications, not just a single cancer type.
Illumina's Chief Commercial Officer, Everett Cunningham, expressed the company's commitment to advancing cancer diagnostics and expanding access to precision oncology. The TruSight Oncology Comprehensive test is distinct in its ability to detect a broad spectrum of gene fusion partners, including those previously unknown, particularly in rare NTRK gene fusions across solid cancers.
Non-small-cell lung cancer, a prevalent form of lung cancer, has underscored the need for extensive molecular profiling. The TruSight Oncology Comprehensive test can identify multiple prognostic and predictive biomarkers, including RET fusions, tumor mutational burden, and other emerging biomarkers, in a single assay.
Dr. Vivek Subbiah of the Sarah Cannon Research Institute recognized the clinical utility of comprehensive genomic profiling for advanced cancer patients. He noted that Illumina's latest IVD kit and accompanying CDx represent valuable clinical tools for matching patients with targeted therapies.
Illumina plans to ship the TruSight Oncology Comprehensive test to customers within this year, with the assurance of Medicare and Medicaid reimbursement for solid tumor assays with CDx claims. The company is also working on expanding its CDx claims through partnerships with pharmaceutical firms, pending regulatory approvals.
The test is already available in Europe, having been launched in 2022 with a CE mark. It is designed for use with the Illumina NextSeq 550Dx Instrument to detect variants in 517 genes from formalin-fixed, paraffin-embedded tumor tissue samples.
This development is based on a press release statement and is part of Illumina's ongoing efforts to enable more personalized treatment options for cancer patients globally.
In other recent news, Illumina Inc (NASDAQ:ILMN). has seen several significant developments. Scotiabank adjusted the company's stock price target to $164 from the previous $176 while maintaining its Sector Outperform rating. This change followed Illumina's Strategy Update call where the company projected a revenue growth acceleration to high single digits by 2027, an improvement in non-GAAP operating margins, and an incremental cost savings of approximately $200 million.
Post-Illumina's GRAIL spinoff, TD Cowen upgraded the company's stock from Hold to Buy and raised the price target from $126 to $144. The firm believes that the spinoff simplifies Illumina's business narrative and allows the company to better focus on its core operations. Stifel also reaffirmed its Buy rating on Illumina, maintaining a steady price target of $160.00. This decision followed Illumina's recent strategy day where the company outlined plans to enhance growth and profitability by launching new products within the next 12 to 18 months.
Illumina has also outlined a strategic vision aimed at accelerating revenue growth and expanding profit margins over the next three years. The company plans to innovate within its genomics portfolio and foster a new research partnership with the Broad Institute of MIT and Harvard to advance single-cell sequencing. The company reported core revenue of $1.1 billion, with non-GAAP operating margins at 22.2%, despite a challenging second quarter in 2024 marked by mixed financial results and strategic shifts.
InvestingPro Insights
In the wake of Illumina, Inc.'s (NASDAQ: ILMN) recent FDA approval for its TruSight Oncology Comprehensive test, the company's financial health and market performance offer additional context for investors. Illumina operates with a moderate level of debt, which is an important consideration for those monitoring the company's financial stability as it advances in the competitive field of precision oncology. Moreover, analysts are optimistic about Illumina's future profitability, predicting the company will be profitable this year, aligning with the company's growth trajectory and product approvals.
Looking at the real-time data from InvestingPro, Illumina's revenue for the last twelve months as of Q2 2024 stands at $4.429 billion. Despite a slight decline in revenue growth during this period, at -0.72%, the company maintains a robust gross profit margin of 66.34%, indicating a strong ability to manage its cost of goods sold and maintain profitability on its products and services. The three-month price total return of 26.03% reflects a strong recent performance in the market, which may be attributed to positive investor sentiment following strategic product developments and regulatory approvals.
While Illumina does not pay a dividend to shareholders, the focus appears to be on reinvesting earnings back into the company to fuel growth and innovation—a strategy that could be beneficial for long-term value creation. For investors seeking deeper analysis and additional insights, there are more InvestingPro Tips available, providing a comprehensive view of Illumina's financial health and market potential.
These InvestingPro Insights are designed to give investors a clearer picture of Illumina's current market position and future outlook as it continues to influence the landscape of cancer diagnostics and precision medicine.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.