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Malaysian Reserve
08-07-2025
- Business
- Malaysian Reserve
$2.35 Billion by 2030: Why In Situ Hybridization Is Revolutionizing Molecular Diagnostics
DELRAY BEACH, Fla. , July 8, 2025 /PRNewswire/ — What's driving the shift to spatially resolved molecular analysis? The global in situ hybridization market, valued at USD 1.64 billion in 2025, is projected to reach USD 2.35 billion by 2030, growing at a CAGR of 7.4%. This growth is driven by the expanding role of ISH in precision medicine, laboratory-developed tests (LDTs), and spatial transcriptomics. Technological innovations—including multiplex ISH, high-sensitivity probes, and automation—are enabling more accurate, efficient, and spatially resolved gene expression analysis in both clinical and research settings. From oncology to neuroscience, ISH is paving the way for advanced diagnostics and next-generation therapeutic strategies. Download PDF Brochure: Why is ISH becoming a molecular game-changer? In Situ Hybridization methods such as FISH and RNA-ISH are increasingly used to detect patient-specific genetic markers at the single-cell level. These techniques offer greater specificity and spatial resolution than conventional assays. For instance, Molecular Instruments' HCR Pro RNA-ISH LDT (Feb 2025) now enables differentiation between psoriasis and atopic dermatitis based on biopsy-derived immunologic markers—transforming diagnostics for millions with chronic skin conditions. Key players like Precision for Medicine, Scantox, and Plus Therapeutics are leveraging ISH to support oncology, gene therapy, and neurodegenerative disease research, further embedding these tools in drug development pipelines and personalized treatment planning. What challenges does ISH solve? ISH technologies address a number of persistent issues in molecular and histopathological diagnostics: Enables precise spatial mapping of gene expression across accuracy in difficult diagnoses where IHC or sequencing alone falls shortSupports multi-target detection for robust biomarker discovery and translational research through integration of transcriptomic and proteomic analyses. For example, Roche's FDA-cleared VENTANA Kappa and Lambda Dual ISH mRNA assay (Jan 2025) enhances lymphoma subtype detection, representing a breakthrough in ISH-based molecular diagnostics. Where is adoption accelerating the fastest? While North America leads with the largest market share due to established infrastructure and funding, rapid growth is forecasted in the Asia Pacific, driven by rising cancer incidence, government funding, and diagnostic modernization. Key momentum drivers include: China, India, and Japan investing heavily in molecular pathology labs expanding ISH capabilities for cancer and infectious disease academic and CRO adoption of automated, scalable ISH platforms. Request Sample Pages : Who are the key leaders—and how are they gaining ground? The ISH market is consolidated, with 5 major players holding 60–65% of global market share: F. Hoffmann-La Roche Ltd (Switzerland): Leading in automated ISH diagnostics, including BenchMark ULTRA PLUS and FDA-cleared lymphoma probes. Danaher (US): Through Leica Biosystems, focuses on integrated automation and spatial biology (US): Dominant in ISH probes for oncology and cytogenetics under the VYSIS (US): RNAscope portfolio expansion to 70,000+ probes position it as a spatial transcriptomics Fisher Scientific (US): Offers a comprehensive suite of ISH instruments and consumables. Recent innovations include: Leica + Bio-Techne (Apr 2025): Automated RNAscope Multiomic LS for spatial + Molecular Instruments (Jan 2025): Launched HCR Pro RNA-ISH for high-sensitivity (Jan 2025): FDA-cleared B-cell ISH + Biocare (Mar 2025): NeoPATH Pro ISH system distributed in the US. What's the biggest challenge—and how do we overcome it? Despite promising advances, high costs and technical complexity remain barriers: Capital investment: ISH instruments like Ventana Benchmark Ultra cost ~$100, Multiplex probe kits and imaging services are costly, with per-slide fees reaching $113 or protocols: Require skilled personnel and careful costs: Advanced scanners such as Vectra can cost $200/hour to operate. Solutions must focus on: User-friendly automation platforms with streamlined optimization to reduce cost per initiatives to expand technical modular platforms for research and clinical users alike. What should diagnostics leaders be asking now? Not 'Is ISH useful?'—but rather: How can ISH improve our ability to detect spatial gene expression at single-cell resolution?Which multiplexing and automation technologies can scale with our diagnostics needs?Are our assays ready for regulatory validation and clinical deployment?How can we integrate transcriptomics and proteomics within one platform? Final Thought: In Spatial Precision, There Is Power. In Multiplexing, There Is Clarity. As genomics shifts toward spatial, multiplexed, and clinically actionable diagnostics, in situ hybridization is evolving from a research tool into a cornerstone of precision healthcare. It's not just about detection anymore—it's about localization, integration, and transformation of diagnostics. In the future of molecular medicine, personalization begins with precision—and ISH is leading the charge. Key Market Players: F. Hoffmann-La Roche Ltd (Switzerland), Danaher (US), Abbott (US), Bio-Techne (US), Thermo Fisher Scientific (US), Bioview (Israel), Biocare Medical (US), Agilent Technologies (US), QIAGEN (Germany), CytoTest Inc. (US), Genemed Biotechnologies (US), ZytoVision GmbH (Germany), Abnova (Taiwan) For more information, Inquire Now! Related Reports: Companion Diagnostics Market Immunohistochemistry Market Tissue Diagnostics Market Immuno Oncology Assays Market Cancer Diagnostics Market Get access to the latest updates on Top Companies in In Situ Hybridization and In Situ Hybridization Market Size About MarketsandMarkets™: MarketsandMarkets™ has been recognized as one of America's Best Management Consulting Firms by Forbes, as per their recent report. MarketsandMarkets™ is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. 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Associated Press
25-04-2025
- Health
- Associated Press
Precision for Medicine and PathAI Announce Strategic Collaboration to Advance AI-Powered Clinical Trial Services and Biospecimen Products
Collaboration will deliver innovative AI-powered pathology tools and quality control enhancements to accelerate clinical trials and biomarker discovery BOSTON and FREDERICK, Md., April 25, 2025 /PRNewswire/ -- Precision for Medicine, a leading provider of next generation drug development research and services, and PathAI, a global leader in digital pathology, today announced a strategic collaboration to partner on developing novel AI-based technologies and to integrate PathAI's advanced digital pathology and analysis capabilities across Precision for Medicine's clinical trial and biospecimen operations. This collaboration includes use of several PathAI technologies and establishes an agreement to offer novel tools and analytical services that address emerging needs in biomarker discovery, spatial biology, and tissue-based clinical research. Through this collaboration PathAI's tools and services will help augment Precision for Medicine's proprietary pipeline providing biopharma clients with access to imaging workflows offered through Precision for Medicine's integrated laboratory and clinical trial services. 'Together, we're deploying tools that add critical quality control steps to tumor biopsy workflows and apply machine-based learning and unsupervised algorithms early in the development cycle to help identify which biomarkers are most relevant for clinical efficacy,' said Darren Davis, PhD, Senior Vice President Global Digital Pathology, Genomics and Liquid Biopsy Solutions. 'Precision for Medicine's CLIA compliant laboratory enables precise patient stratification and accelerate decision-making in clinical trials, ultimately supporting success in areas of high unmet need.' As part of the agreement, Precision for Medicine will deploy select tools from PathAI, including AISight®, a digital pathology image management system, and other AI-powered algorithms to enhance biospecimen and clinical trial services. These tools will enable the application of validated, algorithm-based quality control steps to biospecimen analysis, improving consistency and data reliability. The collaboration will also support the use of PathAI's leading AI capabilities leveraging best in class machine learning based models to enhance Precision for Medicine multi-modal datasets. The technology reduces large, complex biomarker panels to scalable, and actionable, biomarkers to help interpret complex tissue biology to complement translational research programs. Additionally, the companies will work together to analyze complex tissue biology empowering biopharma clients to understand and identify the right patients for the right therapies, faster. 'At PathAI, our mission is to harness the power of artificial intelligence to improve the accuracy, depth, and efficiency of pathology-driven insights,' said Andy Beck, MD, PhD, Co-founder and CEO of PathAI. 'We are thrilled to collaborate with Precision for Medicine to help advance our mission and deliver differentiated value to our mutual customers.' Precision's collaboration with PathAI brings unique value to biopharma clients by combining these AI tools with proprietary wet lab infrastructure, centralized clinical trial operations, and scientific oversight. The innovative tools generated through this collaboration will only be available through Precision for Medicine's services, providing a level of integration and customization not offered elsewhere in the industry. 'This collaboration enhances how we're using our biospecimen business by enabling deeper, more informative analyses of the tissue samples we provide to our clients,' said Cullen Taylor, MD, Medical Director at Precision for Medicine. 'We're adding an entirely new layer of cellular-level insight on top of already well-annotated sequenced samples, going far beyond what traditional pathology assessments can offer. It's a meaningful step forward in how we support biomarker discovery, enhancing datasets for diagnostic validation and therapeutic development.' About Precision for Medicine Precision for Medicine is the first biomarker-driven clinical research and development services organization supporting life sciences companies in the use of biomarkers essential to targeting patient treatments more precisely and effectively. Precision applies a transformational approach to clinical research that integrates clinical trial design and execution with deep scientific knowledge, laboratory expertise, data sciences and advanced manufacturing solutions. This convergence is driving faster clinical development and approval. Precision for Medicine is part of Precision Medicine Group, with 3,500 people in 40 locations globally across North America, Europe and Asia-Pacific. For more information, visit Contact Andie Lunkenheimer [email protected] About PathAI PathAI is a leading provider of integrated AI and digital pathology solutions dedicated to transforming diagnostic accuracy and operational efficiency in pathology labs worldwide. Through innovative technologies and strategic partnerships, PathAI aims to enhance patient outcomes and drive the future of medical diagnostics. For more information, please visit Contact Owen Blaschak [email protected] Footnote 1AISight is for Research Use Only in the US; AISight Dx is CE-IVDR in Europe and UKCA in UK View original content to download multimedia: SOURCE PRECISION FOR MEDICINE