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SAN DIEGO - Illumina Inc. (NASDAQ: ILMN), a $13.1 billion market cap company with annual revenue of $4.3 billion and an impressive 68.6% gross margin, has announced an expansion of its clinical oncology portfolio, which includes the introduction of the FDA-approved TruSight Oncology (TSO) Comprehensive test and the Pillar oncoReveal® CDx diagnostic kit. According to InvestingPro analysis, which offers 14+ exclusive tips for this stock, Illumina currently maintains a FAIR financial health score, suggesting stable operational performance despite recent market challenges. The TSO Comprehensive test, now with broad payer reimbursement, and the upcoming Pillar oncoReveal® CDx, aim to improve patient access to precision oncology and targeted therapies.
The TSO Comprehensive test is the first FDA-approved distributable comprehensive genomic profiling in vitro diagnostic (IVD) kit, which assesses both DNA and RNA to match cancer patients with targeted therapies. This test has been integrated into clinical practice by various healthcare providers across the United States, with UofL Health – UofL Hospital being the first to offer it to patients. While the company’s stock has experienced a 44% decline year-to-date, analysts tracked by InvestingPro indicate the stock is currently trading below its Fair Value, potentially presenting an opportunity for value investors. Medicare plans by the Centers for Medicare & Medicaid Services (CMS), as well as most commercial health plans, now cover the TSO Comprehensive test. Additionally, the IVD kit recently received regulatory approval in Japan.
Illumina’s partnership with Pillar Biosciences will introduce the Pillar oncoReveal® CDx to Illumina customers starting this summer. This diagnostic kit detects genetic variations in 22 genes for patients with solid tumors and has received nationwide Medicare coverage by the CMS. The oncoReveal CDx is designed to facilitate quick and accurate treatment decisions.
Everett Cunningham, Chief Commercial Officer of Illumina, emphasized the importance of tumor profiling in delivering precision cancer care and expressed confidence that the expanded portfolio will set a new standard of care for clinicians and their patients. Mustafa Al-Kawaaz, MD, from the University of Louisville, highlighted the benefits of in-house comprehensive tumor profiling in expediting precision therapy decisions.
The TSO Comprehensive test is also FDA approved as a companion diagnostic (CDx) for certain cancer treatments, such as VITRAKVI for patients with neurotrophic tyrosine receptor kinase (NTRK) gene fusions and RETEVMO for non-small-cell lung cancer (NSCLC) with RET fusion-positive tumors.
This announcement was made in conjunction with the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, where Illumina’s tumor profiling and IVD solutions are being showcased. The information is based on a press release statement from Illumina Inc. Looking ahead, InvestingPro data reveals analysts expect the company to return to profitability this year, with net income growth projected for the upcoming period. For detailed analysis including growth prospects and valuation metrics, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.
In other recent news, Illumina Inc. reported its first-quarter 2025 earnings, revealing an earnings per share (EPS) of $0.97, surpassing analysts’ expectations of $0.94. However, the revenue matched forecasts at $1.04 billion, marking a slight year-over-year decline of 1.4%. The company has initiated a $100 million cost reduction program to address challenges in the research market that are impacting revenue growth. In terms of product development, Illumina announced the release of its latest software, DRAGEN version 4.4, which improves germline structural variant calling accuracy by 30% and introduces new oncology applications. Analyst firms have also weighed in on Illumina’s stock, with Stifel maintaining a Buy rating and a $135 price target, while Canaccord Genuity cut its target to $87, maintaining a Hold rating. TD Cowen raised its price target to $89 but also maintained a Hold rating, citing sustained earnings per share growth despite macroeconomic challenges. These recent developments reflect Illumina’s strategic focus on innovation and cost management amidst external pressures.
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