Illumina's TSO Comprehensive Earns Japan's Approval: Stock to Gain?

Illumina, Inc. ILMN has received approval from Japan’s Ministry of Health, Labour and Welfare for TruSightTM Oncology (TSO) Comprehensive for Class III/IV Medical Device (Specially Controlled Medical Device). As genomic insights continue to drive breakthroughs in cancer treatment, the test is designed to make precision oncology more accessible to oncologists and patients.

The latest development bolsters the company’s oncology portfolio. Illumina also stated that its clinical oncology offerings will be featured at the ASCO Annual Meeting in Chicago, to be held between May 30 and June 3.

ILMN Stock’s Likely Trend Following the News

Since the announcement on May 26, ILMN shares jumped 2.6%, closing at $82.49 yesterday. The company’s oncology portfolio offers versatile, scalable solutions — from low to high-throughput instruments — to meet global customer needs. Through pharmaceutical partnerships, it is developing an expanding pipeline of companion diagnostics (CDx), ultimately driving progress in cancer diagnostics and precision medicine. As a result, we expect the news to boost market sentiment toward ILMN stock.

Illumina presently has a market capitalization of $12.72 billion. The company’s earnings yield of 5.3% sits comfortably against the industry’s -31.5% yield. It delivered an earnings beat of 56.4%, on average, in the trailing four quarters.

More on Illumina’s TSO Comprehensive

The TSO Comprehensive is the first U.S. FDA-approved, distributable comprehensive genomic profiling in vitro diagnostics (IVD) kit with pan-cancer CDx claims in the United States. A separate CE-marked version was launched in Europe in 2022.

The single test includes analysis of DNA and RNA variants and interrogates more than 500 genes to profile a patient’s solid tumor, helping increase the likelihood of identifying clinically actionable biomarkers that enable targeted therapy selection or clinical trial enrolment. Powered by a streamlined, automated sample-to-report workflow, the CGP test will enable clinicians in Japan to accelerate access to personalized medicine decisions with greater efficiency and precision. 

Industry Prospects Favor ILMN

Per a Research report, the global precision genomic testing market was valued at $15.49 billion in 2024 and is expected to grow at a compound annual rate of 14.8% through 2030. This market includes a variety of diagnostic tools and techniques to analyze genetic information, leading to more accurate diagnoses, targeted therapies and improved patient outcomes. Rising demand for precision genomic testing is fueled by the need for early disease detection, effective treatment planning and better management of chronic conditions.

Other Developments at Illumina

This month, the company launched the DRAGEN version 4.4 software (v4.4), which includes out-of-the-box oncology applications for clinical research and support for newly announced Illumina multiomics assays. DRAGEN v4.4 enhancements will simplify next-generation sequencing (NGS) analysis for customers while expanding their capabilities. In addition, Illumina, in partnership with Ovation.io, Inc., announced the development of the largest commercially available clinical multiomic dataset from 25,000 patients treated with glucagon-like peptide-1 (GLP-1) receptor agonist therapies. The dataset will be made available to the pharma community to advance drug discovery and development.

ILMN Stock Price Performance

Over the past three months, ILMN shares have fallen 7.1% compared with the industry’s 11.6% decline.

Illumina’s Zacks Rank and Key Picks

Illumina currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space include Phibro Animal Health PAHC, Hims & Hers Health HIMS and Prestige Consumer Healthcare PBH. While Phibro Animal Health sports a Zacks Rank #1 (Strong Buy) at present, Hims & Hers Health and Prestige Consumer Health each carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Estimates for Phibro Animal Health’s fiscal 2025 earnings per share have jumped 3.6% to $2.01 in the past 30 days. Shares of the company have rallied 37.9% in the past year compared with the industry’s 10.1% growth. Its earnings yield of 8.7% compares comfortably with the industry’s 0.5% yield. PAHC’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 30.6%.

Hims & Hers Health shares have surged 172.5% in the past year. Estimates for the company’s 2025 earnings per share have jumped 12.5% to 72 cents in the past 30 days. HIMS’ earnings beat estimates twice in the trailing four quarters, matched in one and missed on another occasion, the average surprise being 19.6%. In the last reported quarter, it posted an earnings surprise of 66.7%.

Estimates for Prestige Consumer Healthcare’sfiscal 2026 earnings per share have increased 1 cent to $4.77 in the past 30 days. Shares of the company have jumped 37.2% in the past year compared with the industry’s 10.1% growth. PBH’s earnings surpassed estimates in three of the trailing four quarters and matched on one occasion, the average surprise being 2.8%. In the last reported quarter, it delivered an earnings surprise of 1.5%.

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This article originally published on Zacks Investment Research (zacks.com).

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