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New CDx partnerships expand ILMN's pipeline supporting precision oncology care.
Illumina, Inc. (ILMN - Free Report) is set to partner with several global pharmaceutical companies to develop companion diagnostics (CDx) enabled on the TruSight Oncology (“TSO”) Comprehensive genomic profiling test. The new CDx partnerships will focus on KRAS alterations, which are known to cause uncontrolled cell growth, leading to cancer.
The company’s continued expansion of tumor-agnostic CDx claims highlights its commitment to advancing access for patients to precision oncology care by generating standardized, globally distributable tests.
Relevance of Illumina’s New Partnerships
CDx, built on TSO Comprehensive, helps 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.
Recent advances in genomics have made it possible to detect KRAS variants 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. Genomics insights into KRAS not only enhance the understanding of KRAS-driven tumor biology but also pave the way for more personalized therapeutic strategies.
According to key ILMN leadership, developing CDx claims for the historically important KRAS biomarker will enable broader identification of patients who may benefit from targeted therapies, regardless of tumor origin. 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 improve the lives of cancer patients.
Industry Prospects Favor ILMN
Per a Research report, the global CDx market was valued at $9.06 billion in 2024 and is projected to witness a compound annual growth rate of 10.5% through 2030.
The increasing prevalence of cancer, cardiovascular diseases and autoimmune disorders is pushing up the demand for targeted therapies, where CDx helps determine the most effective treatment for patients. This approach reduces adverse effects and enhances treatment efficacy, improving patient outcomes. Furthermore, pharmaceutical companies are incorporating CDx into drug development pipelines to improve the success rate of novel therapeutics, fueling the market’s growth.
Other Developments at Illumina
Illumina introduced the Illumina Protein Prep, an assay introducing superior performance for next-generation sequencing (NGS)-based proteomics discovery at scale. The development follows the company’s June announcement to acquire SomaLogic, a renowned name in data-driven proteomics technology. The Illumina Protein Prep is powered by SOMAmer technology and can measure 9500 unique human protein targets, the most with an NGS readout, offering the greatest insights into protein biology.
Recent Moves by Illumina’s CDx Peers
Leading precision medicine company, Myriad Genetics (MYGN - Free Report) , has announced a strategic collaboration with SOPHiA GENETICS to develop a global liquid biopsy CDx test. The partnership will leverage MYGN’s advanced U.S. laboratory capabilities to support global testing for clinical trials and SOPHiA GENETICS’ broad, decentralized network of more than 800 connected institutions in more than 70 countries for global test deployment.
In addition, a study highlighting the performance of Myriad Genetics’ molecular residual disease (MRD) test, Precise MRD, in patients with oligometastatic clear-cell renal cell carcinoma (ccRCC), was recently published in The Lancet Oncology. The study demonstrated that the test was able to detect a wide range of circulating tumor DNA (ctDNA) levels — from very high to very low — associated with response to metastasis-driven therapy.
QIAGEN (QGEN - Free Report) , the renowned Sample to Insight solutions provider, has secured CE-IVDR certification for its full QIAstat-Dx portfolio. This includes the syndromic testing systems and panels, including an expanded Meningitis/Encephalitis Panel that marks a major advancement in the diagnosis of central nervous system infections.
QIAGEN also recently secured the FDA’s clearance for QIAstat???Dx Rise — a version of the QIAstat-Dx automated syndromic testing system that offers unmatched throughput with the easiest workflow. The system is designed to meet the needs of hospitals and reference laboratories that require highly automated syndromic testing, with automated loading and unloading of cartridges, access to priority handling of urgent samples and minimal hands-on time.
Thermo Fisher Scientific (TMO - Free Report) , a global leader in serving science, has launched the Thermo Scientific Hypulse Surface Analysis System. This surface analysis instrument marks a major step forward in accurate X-ray photoelectron spectroscopy (XPS) depth-profiling, which is critical for materials scientists worldwide.
Furthermore, Thermo Fisher announced the launch of the Olink Target 48 Neurodegeneration panel — a high-performance, targeted proteomics immunoassay panel developed to accelerate discoveries in neurodegenerative disease research. It delivers simultaneous measurement of 41 key and emerging proteins for neurodegeneration research with absolute quantification and is optimized for plasma measurement from as little as 1µL of sample.
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Illumina to Join Pharma Partners for CDx Development on KRAS Biomarker
Key Takeaways
Illumina, Inc. (ILMN - Free Report) is set to partner with several global pharmaceutical companies to develop companion diagnostics (CDx) enabled on the TruSight Oncology (“TSO”) Comprehensive genomic profiling test. The new CDx partnerships will focus on KRAS alterations, which are known to cause uncontrolled cell growth, leading to cancer.
The company’s continued expansion of tumor-agnostic CDx claims highlights its commitment to advancing access for patients to precision oncology care by generating standardized, globally distributable tests.
Relevance of Illumina’s New Partnerships
CDx, built on TSO Comprehensive, helps 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.
Recent advances in genomics have made it possible to detect KRAS variants 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. Genomics insights into KRAS not only enhance the understanding of KRAS-driven tumor biology but also pave the way for more personalized therapeutic strategies.
According to key ILMN leadership, developing CDx claims for the historically important KRAS biomarker will enable broader identification of patients who may benefit from targeted therapies, regardless of tumor origin. 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 improve the lives of cancer patients.
Industry Prospects Favor ILMN
Per a Research report, the global CDx market was valued at $9.06 billion in 2024 and is projected to witness a compound annual growth rate of 10.5% through 2030.
The increasing prevalence of cancer, cardiovascular diseases and autoimmune disorders is pushing up the demand for targeted therapies, where CDx helps determine the most effective treatment for patients. This approach reduces adverse effects and enhances treatment efficacy, improving patient outcomes. Furthermore, pharmaceutical companies are incorporating CDx into drug development pipelines to improve the success rate of novel therapeutics, fueling the market’s growth.
Other Developments at Illumina
Illumina introduced the Illumina Protein Prep, an assay introducing superior performance for next-generation sequencing (NGS)-based proteomics discovery at scale. The development follows the company’s June announcement to acquire SomaLogic, a renowned name in data-driven proteomics technology. The Illumina Protein Prep is powered by SOMAmer technology and can measure 9500 unique human protein targets, the most with an NGS readout, offering the greatest insights into protein biology.
Recent Moves by Illumina’s CDx Peers
Leading precision medicine company, Myriad Genetics (MYGN - Free Report) , has announced a strategic collaboration with SOPHiA GENETICS to develop a global liquid biopsy CDx test. The partnership will leverage MYGN’s advanced U.S. laboratory capabilities to support global testing for clinical trials and SOPHiA GENETICS’ broad, decentralized network of more than 800 connected institutions in more than 70 countries for global test deployment.
In addition, a study highlighting the performance of Myriad Genetics’ molecular residual disease (MRD) test, Precise MRD, in patients with oligometastatic clear-cell renal cell carcinoma (ccRCC), was recently published in The Lancet Oncology. The study demonstrated that the test was able to detect a wide range of circulating tumor DNA (ctDNA) levels — from very high to very low — associated with response to metastasis-driven therapy.
QIAGEN (QGEN - Free Report) , the renowned Sample to Insight solutions provider, has secured CE-IVDR certification for its full QIAstat-Dx portfolio. This includes the syndromic testing systems and panels, including an expanded Meningitis/Encephalitis Panel that marks a major advancement in the diagnosis of central nervous system infections.
QIAGEN also recently secured the FDA’s clearance for QIAstat???Dx Rise — a version of the QIAstat-Dx automated syndromic testing system that offers unmatched throughput with the easiest workflow. The system is designed to meet the needs of hospitals and reference laboratories that require highly automated syndromic testing, with automated loading and unloading of cartridges, access to priority handling of urgent samples and minimal hands-on time.
Thermo Fisher Scientific (TMO - Free Report) , a global leader in serving science, has launched the Thermo Scientific Hypulse Surface Analysis System. This surface analysis instrument marks a major step forward in accurate X-ray photoelectron spectroscopy (XPS) depth-profiling, which is critical for materials scientists worldwide.
Furthermore, Thermo Fisher announced the launch of the Olink Target 48 Neurodegeneration panel — a high-performance, targeted proteomics immunoassay panel developed to accelerate discoveries in neurodegenerative disease research. It delivers simultaneous measurement of 41 key and emerging proteins for neurodegeneration research with absolute quantification and is optimized for plasma measurement from as little as 1µL of sample.