Illumina advances personalized cancer care with new pharma development partnerships

Illumina and pharma partners will develop companion diagnostics for historically important KRAS biomarker

SAN DIEGO, Sept. 23, 2025 /PRNewswire/ -- Illumina Inc. (NASDAQ:ILMN) will partner with multiple global pharmaceutical companies to develop companion diagnostics (CDx) enabled on the TruSight™ Oncology (TSO) Comprehensive genomic profiling test. The continued expansion of tumor-agnostic CDx claims underscores Illumina's commitment to advance access for patients to precision oncology care by generating standardized, globally distributable tests. The new companion diagnostic partnerships will focus on KRAS alterations, which are known to cause uncontrolled cell growth, leading to cancer.

"Developing companion diagnostic claims for the historically important KRAS biomarker will enable broader identification of patients who may benefit from targeted therapies, regardless of tumor origin," said Traci Pawlowski, vice president and head of Clinical Solutions at Illumina. "This marks a critical step forward as we build our clinical offerings to support clinicians and pharmaceutical partners in delivering more personalized, effective, and broadly accessible precision cancer care."

Genomic profiling with CDx helps match patients to precision therapies

CDx built on TSO Comprehensive help clinicians match patients with approved targeted therapies based on the genetic mutations underlying their cancer. TSO Comprehensive does this by generating a molecular tumor profile that can identify the genetic mutations driving cancer growth. To target those underlying mutations, clinicians use the CDx to confirm whether a patient is a candidate for a targeted therapy or clinical trial.

KRAS is one of the most commonly mutated oncogenes in cancer, driving tumor proliferation, survival, and progression. Given its prominence in cellular transformation, previous research has demonstrated that identifying KRAS variants is critical for proper therapy selection and improving patient outcomes.^1,2

Genomics paves the way in precision oncology

Recent advances using genomics to detect KRAS variants have been successfully demonstrated across cancer types despite historical challenges in targeting KRAS. This includes traditionally difficult-to-treat diseases like pancreatic ductal adenocarcinoma, leading to opportunities for improved prognostication and treatment decisions.^1,2 Genomics insights into KRAS both enhance our understanding of KRAS-driven tumor biology and pave the way for more personalized therapeutic strategies.

"KRAS mutations are common across cancer types but have historically been difficult to address," said Kashif Firozvi, MD, Maryland Oncology Hematology. "The field is evolving rapidly, with new therapies better suited to patients with mutations in this once 'undruggable' gene. As the treatment landscape expands, including drugs that target the KRAS pathway, knowing a patient's KRAS status becomes essential to guiding effective treatment protocols and improving outcomes."

Illumina maintains a growing pipeline of CDx claims under development through partnerships with pharmaceutical companies, which will continue to support groundbreaking targeted therapies and immunotherapies to make a difference in the lives of patients with cancer.

To learn more about TruSight Oncology Comprehensive, click here.

References:

1. Isermann T, Sers C, Der CJ, Papke B. KRAS inhibitors: resistance drivers and combinatorial strategies. Trends in Cancer. 2025;11(2): 91-116. doi:10.1016/j.trecan.2024.11.009
2. Fakih MM. KRAS Mutation Screening in Colorectal Cancer: From Paper to Practice. Clinical Colorectal Cancer. 2010;9(1): 22-30. doi:10.3816/CCC.2010.n.003

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) challenges inherent in developing, manufacturing, and launching new products and services; (ii) customer uptake of, and satisfaction with, new products and services; (iii) legislative, regulatory and economic developments; (iv) our ability to manufacture robust instrumentation and consumables; (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.

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SOURCE Illumina, Inc.