Illumina to Join Pharma Partners for CDx Development on KRAS Biomarker

Illumina, Inc. ILMN 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 PartnershipsCDx, 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 ILMNPer 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 IlluminaIllumina 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 PeersLeading precision medicine company, Myriad Genetics MYGN, 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, 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, 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.Free Report: Profiting from the 2nd Wave of AI ExplosionThe next phase of the AI explosion is poised to create significant wealth for investors, especially those who get in early. It will add literally trillion of dollars to the economy and revolutionize nearly every part of our lives.Investors who bought shares like Nvidia at the right time have had a shot at huge gains.But the rocket ride in the "first wave" of AI stocks may soon come to an end. The sharp upward trajectory of these stocks will begin to level off, leaving exponential growth to a new wave of cutting-edge companies.Zacks' AI Boom 2.0: The Second Wave report reveals 4 under-the-radar companies that may soon be shining stars of AI’s next leap forward.Access AI Boom 2.0 now, absolutely free >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Thermo Fisher Scientific Inc. (TMO): Free Stock Analysis Report Illumina, Inc. (ILMN): Free Stock Analysis Report Myriad Genetics, Inc. (MYGN): Free Stock Analysis Report QIAGEN N.V. 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