Illumina advances personalized cancer care with new pharma development partnerships

Rhea-AI Summary

Illumina (NASDAQ:ILMN) has announced new partnerships with global pharmaceutical companies to develop companion diagnostics (CDx) for the KRAS biomarker using their TruSight™ Oncology Comprehensive genomic profiling test.

The partnerships aim to advance personalized cancer care by helping clinicians match patients with targeted therapies based on genetic mutations. KRAS, one of the most commonly mutated oncogenes in cancer, has historically been difficult to target. The CDx development will enable broader identification of patients who may benefit from targeted therapies, regardless of tumor origin.

The initiative represents a significant advancement in precision oncology, particularly for traditionally difficult-to-treat diseases like pancreatic ductal adenocarcinoma. The genomic profiling capabilities will help improve patient prognostication and treatment decisions through better understanding of KRAS-driven tumor biology.

Positive

• Development of companion diagnostics for historically challenging KRAS biomarker
• Expansion of tumor-agnostic CDx claims for broader patient identification
• Enhanced ability to match patients with targeted therapies across cancer types
• Potential improvement in treatment outcomes for difficult-to-treat cancers

Negative

• Historical challenges in targeting KRAS mutations
• Complex development and regulatory approval process for companion diagnostics
• Potential manufacturing and implementation challenges mentioned in forward-looking statements

Insights

Biotechnology Analyst

Illumina's new pharma partnerships to develop KRAS companion diagnostics strengthen its position in the growing precision oncology market.

Illumina's announcement of multiple pharmaceutical partnerships to develop companion diagnostics (CDx) for KRAS biomarkers represents a strategic expansion of its precision oncology portfolio. By integrating these CDx claims into their TruSight™ Oncology Comprehensive genomic profiling test, Illumina is positioning itself at the intersection of diagnostics and targeted therapy selection – a critical growth area in oncology.

KRAS mutations are particularly significant targets because they appear in approximately 25% of all tumors and have historically been considered "undruggable." Recent breakthroughs in KRAS-targeted therapies have changed this paradigm, creating substantial demand for reliable testing to identify eligible patients. This explains why Illumina is pursuing partnerships with multiple pharmaceutical companies simultaneously rather than an exclusive arrangement.

The tumor-agnostic approach Illumina is taking with these companion diagnostics is especially valuable. Instead of developing separate tests for each cancer type, their platform can identify actionable KRAS mutations regardless of the tumor's origin. This universality enhances the commercial potential of their diagnostic platform while simplifying implementation for healthcare providers.

For Illumina's business model, these partnerships create multiple revenue opportunities: initial test sales, potential royalties from associated therapies, and establishing their platform as the standard for precision oncology testing. As pharmaceutical companies continue developing targeted therapies for previously "undruggable" genetic drivers, Illumina's comprehensive genomic profiling infrastructure becomes increasingly valuable.

The timing aligns with broader market shifts toward targeted therapies and biomarker-driven treatment selection across oncology, positioning Illumina to capture value in both the diagnostic and therapeutic segments of the precision medicine ecosystem.

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.

Contacts

Investors:
Brian Blanchett
IR@illumina.com

Media:
Christine Douglass
PR@illumina.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/illumina-advances-personalized-cancer-care-with-new-pharma-development-partnerships-302564027.html

SOURCE Illumina, Inc.

FAQ

What is Illumina's new partnership announcement for cancer diagnostics?

Illumina is partnering with multiple global pharmaceutical companies to develop companion diagnostics (CDx) for the KRAS biomarker using their TruSight™ Oncology Comprehensive genomic profiling test.

How will ILMN's KRAS companion diagnostics benefit cancer patients?

The diagnostics will help identify patients who may benefit from targeted therapies regardless of tumor origin, enabling more personalized and effective cancer treatment through genetic mutation identification.

What is the significance of KRAS in cancer treatment?

KRAS is one of the most commonly mutated oncogenes in cancer, driving tumor growth. Identifying KRAS variants is critical for proper therapy selection and improving patient outcomes.

How does Illumina's TruSight Oncology Comprehensive test work?

The test generates a molecular tumor profile that identifies genetic mutations driving cancer growth, helping clinicians match patients with approved targeted therapies or clinical trials.

What types of cancers will benefit from Illumina's KRAS diagnostics?

The diagnostics will benefit multiple cancer types, including traditionally difficult-to-treat diseases like pancreatic ductal adenocarcinoma, by enabling better prognostication and treatment decisions.