Illumina Announces Strategic Collaboration to Develop KRAS Companion Diagnostic Based on TruSight™ Oncology Comprehensive

Sep 24, 2025 14:05 CST Updated 14:05

Illumina

Diagnostic Product Developer

San Diego, California, USA – September 23, 2025 – Illumina, Inc. (NASDAQ: ILMN) will partner with multiple global pharmaceutical companies to develop companion diagnostic tests based on the TruSight™ Oncology (TSO) Comprehensive genomic profiling assay. The ongoing expansion of tumor-agnostic companion diagnostic applications underscores Illumina's commitment to improving patient access to precision oncology care through standardized testing solutions that can be adopted worldwide. The new companion diagnostic collaborations will focus on KRAS gene mutations, which are known to cause uncontrolled cell growth leading to cancer.

"Developing a companion diagnostic test for the key biomarker KRAS will help more broadly identify patients who may benefit from targeted therapies, regardless of the primary tumor site."Traci Pawlowski, Vice President and Head of Illumina's Clinical Solutions, stated"This marks a crucial step forward in building our clinical product portfolio, aimed at supporting clinicians and pharmaceutical partners to deliver more personalized, effective, and widely accessible precision cancer care."

Genomic analysis combined with companion diagnostic testing,

Help Patients Match Precise Treatment

Companion diagnostic testing based on TSO Comprehensive can help clinicians match patients with approved targeted therapies according to genetic mutations in cancer. TSO Comprehensive identifies genetic mutations that drive cancer growth by generating a molecular tumor profile. For these potential mutations, clinicians use companion diagnostic testing to confirm whether patients are eligible to receive targeted treatment or participate in clinical trials.

KRAS is one of the most commonly mutated oncogenes in cancer, driving tumor proliferation, survival, and progression. Given its importance in cellular transformation, previous studies have shown that identifying KRAS mutations is crucial for the appropriate selection of treatment strategies and improving patient outcomes.^1,2

Genomics Drives New Advances in Precision Oncology

Despite the historical challenges in targeting KRAS, recent advancements in genomic testing for KRAS mutations have been successfully validated across various cancer types. This includes traditionally difficult-to-treat diseases such as pancreatic ductal adenocarcinoma, offering new opportunities to improve prognostic evaluation and treatment decisions.^1,2Genomic insights into KRAS not only deepen our understanding of the biology of KRAS-driven tumors but also lay the foundation for developing more personalized treatment strategies.

"KRAS mutations are common in various types of cancer but have long been difficult to treat effectively."Kashif Firozvi, MD, from the Maryland Oncology Hematology Center, stated"The field is rapidly evolving, and new treatment options are providing more choices for patients with this once 'undruggable' genetic mutation. As the treatment landscape expands to include drugs targeting the KRAS pathway, understanding a patient’s KRAS status is crucial for developing effective treatment strategies and improving outcomes."

Illumina, Inc. continues to expand its pipeline of companion diagnostic applications in development through collaborations with pharmaceutical companies, supporting breakthrough targeted therapies and immunotherapies to bring change to the lives of cancer patients.