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Nodality, Inc. Reports Promising Rheumatoid Arthritis Study Results to Predict Patient Treatment Response to TNF Inhibitors

Nodality, Inc., an innovative biotechnology company advancing discovery, development and use of transformative therapies by revealing functional systems biology, recently announced results of the Company’s comprehensive research study to identify cell markers (biomarkers) of disease activity and treatment success in rheumatoid arthritis (RA) patients. The study findings demonstrated that Nodality’s SCNP technology, which measures functional pathways at the single cell level, can be used to identify biomarkers of responsiveness to treatment with tumor necrosis factor inhibitors (TNFIs). RA affects an estimated two million Americans, and TNFIs constitute the most commonly prescribed therapy. Approximately half of patients respond to treatments such as TNFIs, leaving a substantial unmet need to identify which patients are more likely to respond to current therapies. Optimizing use of currently available therapies could potentially delay tissue damage and progression of disease.

SCNP provides the core technology foundation for Nodality’s programs dedicated to improving clinical medicine by increasing the efficiency of therapeutic R&D programs, enhancing life cycle management for commercialized drugs, and introducing new predictive diagnostics. The study results were featured in an oral presentation titled, Comparison of functional immune signaling profiles in peripheral blood mononuclear cells (PBMC) from rheumatoid arthritis (RA) patients versus healthy donors (HD) using Single Cell Network Profiling (SCNP) (Abstract W7.02.04), at the 15th International Congress of Immunology (ICI) in Milan, Italy, taking place August 22 to 27, 2013. The findings were presented by S. Louis Bridges, Jr., M.D., Ph.D., Marguerite Jones Harbert-Gene V. Ball, MD Professor of Medicine, Director, Division of Clinical Immunology and Rheumatology, University of Alabama School of Medicine.

“Nodality’s research program demonstrates the great promise and potential in gaining a better understanding of disease biology and applying this to the development of prognostic and predictive biomarkers for autoimmune diseases such as RA,” commented Alessandra Cesano, M.D., Ph.D., Chief Medical Officer of Nodality. “I look forward to the final results of this program, one of the most comprehensive of its kind. Our technology, based on immune-biology, can predict which RA patients will respond to specific therapies and reveal the mechanisms of drug resistance, thus informing alternative therapeutic strategies.”

The Nodality research program compares healthy and diseased peripheral blood cells at the single cell level, studying samples obtained through the national Treatment Efficacy and Toxicity in Rheumatoid Arthritis Database and Repository (TETRAD). Nodality anticipates completing its research program and announcing the key findings later this year.

Laura Brege, Nodality’s President and Chief Executive Officer, stated, “ICI has provided an important opportunity to showcase one of our key programs in immunology, further validating our broadly enabling SCNP platform. This platform has led to major collaborations in immunology addressing significant unmet needs among patients, as well as new predictive diagnostic modalities in blood cancers. Ultimately, Nodality’s goal is to accelerate and make more efficient the development of new therapeutic agents for serious diseases affecting large patient populations within immunology and oncology, two areas of continuing significant unmet clinical need.”

Additional program results were featured in a second oral presentation at the ICI Congress in a presentation titled, Functional proteomic interrogation of immune cell crosstalk and the effects of cytokine-targeted inhibitors using Single Cell Network Profiling (SCNP) (Abstract W7.02.03).

Source: Nodality, Inc

Metabolon Expands Biochemical Profiling Capabilities with The New Truevision™ Metabolomics Offering and Online Client Tools

Metabolon, the pioneering leader in metabolomics-driven biomarker discovery and analysis, recently announced expanded capabilities in its extensive biochemical profiling technology. The new TrueVision™ offering combines Metabolon’s powerful biochemical profiling discovery platform with complex lipid profiling. With this expansion, Metabolon can survey biological samples for over 4000 known metabolites contained in its chemical library and provide a more complete picture of lipid metabolism. The acquisition of Lipomics Technologies in 2012, now operating as a division of Metabolon with core competency in lipidomics, has enabled this unprecedented new capability.

Michael Milburn, Chief Scientific Officer at Metabolon, commented “The new TrueVision™ offering is the result of our commitment to meet our clients’ needs to find answers to their critical biological questions, advance their research, and is evidence of our dedication to continuous innovation in the field of metabolomics.”

Metabolon’s TrueVision™ platform has extensive application across the life sciences for biomarker discovery and elucidation of the effects of drugs or nutrients on metabolism. In addition, TrueVision™ provides insight into disease biology, in particular metabolic diseases, which are a family of disorders driven in large part by the subtle, long-term dysregulation of lipid metabolism. Metabolism in general and especially lipid metabolism are thought to play an important role in the development of cancer, inflammatory and central nervous system disorders which makes this comprehensive offering ideally suited for research in these therapeutic areas.

The company is also unveiling the newest version of Client Tools, a secure web portal for data delivery, interpretation and visualization of its lipidomics profiles. Client Tools includes Lipomics Surveyor® pathway maps for each analytical panel, allowing customers to view differences in lipid metabolism between treatment groups, organized by metabolic pathways. “This new software tool expands the ability of clients to visualize, present and interpret their focused lipid panel study data”, states Steve Watkins, Chief Technology Officer, Metabolon.

Source: Metabolon

QIAGEN Acquires Ingenuity Systems, Adding Leading Solution for Analysis and Interpretation of Complex Biological Data

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced the acquisition of Ingenuity Systems, Inc., the leading provider of software solutions to efficiently and accurately analyze and interpret the biological meaning of genomic data.

Ingenuity, a privately-held U.S. company based in California’s Silicon Valley, has created the market leading expertly curated knowledge system of biomedical information and analysis solutions for the exploration, interpretation and analysis of complex biological systems.

New technologies such as next-generation sequencing (NGS) are now generating more data in a single year than was created in all prior history, making the analysis and interpretation of this extensive and very complex biological data a critical success factor.

The foundation of Ingenuity’s product portfolio is the Ingenuity Knowledge Base, a 14-year effort to accurately, manually curate, model and computationally structure the vast amount of biomedical literature, including genomic variations implicated in human disease and thousands of disease models. The Ingenuity Knowledge Base and software applications enable users to accurately interpret the meaning of increasingly large amounts of biological data to better guide scientific experiments and medical treatment decisions.

“The interpretation of biological information is becoming a cornerstone of QIAGEN’s ecosystem of Sample & Assay Technologies for molecular testing – both in life sciences research and in diagnostics. We are establishing a leading role in this field and intend to further expand the value proposition and scope of our offering,” said Peer M. Schatz , Chief Executive Officer of QIAGEN N.V. “Ingenuity has created unparalleled leadership with its Knowledge Base and interpretation solutions to unlock the value of complex genomic and other biological information. Combining the highest-quality knowledge content with powerful search capabilities and easy-to-use interfaces, the Ingenuity suite provides customers with scientifically and clinically relevant insights into diseases. We are looking forward to expanding the seamless integration of leading biomedical information solutions into our full range of molecular testing solutions, thereby providing our customers a unique experience from sample to interpreted result and recommendations for next steps. Integration of Ingenuity’s solutions into a powerful, full-range ecosystem of QIAGEN’s molecular testing solutions, such as PCR and next-generation sequencing, promises to offer significant value to QIAGEN customers and shareholders.”

“Today we can sequence an entire human genome in just a couple of days for less than a few thousand dollars, but the data analysis can take from months to years. The Ingenuity suite of products enables this rapid and accurate interpretation in a matter of minutes, and this is fundamentally impacting scientific research and the ability to diagnose and manage patient care,” saidJake Leschly , President and CEO of Ingenuity Systems. “The Ingenuity mission from day one has been to accelerate scientific discovery and enhance clinical decision-making through a rich understanding of biological systems. As part of QIAGEN, we will offer our biological knowledge content and software in the context of a best-in-class ecosystem of molecular testing solutions and to a greatly expanded range of customers around the world.”

Ingenuity’s Knowledge Base is built on algorithms that pair all human gene variants with biological interpretations based on known outcomes and findings. These pairings are collected and reviewed by experts (curated) in a standardized way from a wide range of sources including clinical and scientific publications with the support of advanced technology and refined processes. This process and the associated learning algorithms translate sourced data into interoperable and linkable collections of relevant information. The leadership of Ingenuity’s products grows out of a long-standing commitment to ensure the highest standards, particularly in the use of expert teams, supported by the most advanced technology.

Ingenuity product offerings include:

  • Ingenuity® Pathways Analysis™(IPA) is the industry gold standard web-based software application that enables researchers to model, analyze and understand the complex biological systems at the core of life sciences research. IPA is deployed in most major pharmaceutical companies and hundreds of biotechnology companies and academic institutions globally. It supports data analysis and interpretation from all high-throughput analysis platforms and is used in virtually all areas of drug discovery and development from target identification and validation to biomarkers, predictive toxicology and pharmacogenomics. IPA has been cited in thousands of peer-reviewed journal articles.
  • Ingenuity®Variant Analysis™ is a web-based NGS data analysis application that answers a critical need for researchers trying to rapidly identify relevant causal variants in human diseases in a matter of hours. It enables customers to rapidly identify and prioritize variants by drilling down to a small, targeted subset of compelling variants based upon published biological evidence and their own knowledge of disease biology. Customers can also interrogate variants from multiple biological perspectives, explore different biological hypotheses and identify the most promising variants for follow-up analysis. Thousands of users from leading institutions around the world have already uploaded genomic data using Ingenuity Variant Analysis, which has been used to analyze more than 45,000 biological samples so far. Ingenuity is fully committed to meeting the highest standards for its Data Center operations and Ingenuity Variant Analysis, and announced in February 2013 that it had passed an audit under the U.S. Health Insurance Portability and Accountability Act (HIPAA) and is compliant with the U.S.-EU Safe Harbor framework.
  • Ingenuity®iReport™ is an interactive web-based report optimized for gene expression experiments from RNA-Seq, microarray and real-time PCR platforms. It provides fast and accurate biological and statistical analysis of a customer’s biological data.

Ingenuity is also developing a new product to enable broader adoption of NGS in molecular diagnostics by offering an optimized and scalable solution for interpreting and scoring clinical variants identified by sequencing-based molecular diagnostic tests. The company has been actively forming relationships with reference laboratories to bring the power of this technology to these customers, including through cloud-based applications.

Ingenuity will significantly expand and strengthen QIAGEN’s own curated database, which is commercialized embedded in wet lab assays sold through QIAGEN’s highly successful GeneGlobe content portal. GeneGlobe offers hundreds of assay panels for PCR and NGS as well as more than 60,000 fully annotated molecular assays for the most sought-after diseases and pathways, curated from the biomedical literature.

Ingenuity’s solutions are used by tens of thousands of researchers and clinicians at hundreds of leading pharmaceutical, biotechnology, academic, diagnostic and clinical institutions worldwide. Many members of Ingenuity’s senior management team, including Mr. Leschly, will continue with QIAGEN, and the offices will remain in Redwood City, California. Ingenuity Systems was selected as a 2013 Technology Pioneer by the World Economic Forum For more information on Ingenuity’s technology platform and products, go to http://www.ingenuity.com/.

Source: Ingenuity Systems

The Scientist Webinar: Tackling the Challenges Involved with Protein Biomarkers

Protein biomarkers have been hailed as vital stepping stones in the race to personalize medicine. But many hurdles remain to be cleared before their application becomes routine. Currently, protein biomarkers have proven useful in drug discovery and development, as tools for target discovery and evaluation of a drug’s mechanism of action, and in therapies for prevention, early detection, diagnosis, and treatment of disease. Although single markers are in use, more widespread adoption will probably require a multiplexed panel capable of detecting and measuring biomarkers accurately, inexpensively, and easily in biological samples that are highly complex.

Crescendo Bioscience’s Vectra DA Test Indicates Remission in Rheumatoid Arthritis Patients

Crescendo Bioscience, Inc., a molecular diagnostics company developing quantitative biomarker tests for rheumatoid arthritis (RA) and other inflammatory diseases, today announced data indicating that the Company’s multi-biomarker blood test, Vectra™ DA, may help identify patients in remission based on measuring 12 protein biomarkers that indicate the overall level of RA disease activity. Patients in remission according to the Vectra DA algorithm showed a lower observed risk of radiographic progression over the next year than those in remission according to other clinical remission criteria examined in a study. Moreover, a high Vectra DA algorithm was associated with an increased risk of joint damage progression during the next year, even in patients classified as being in remission by clinical assessment. Additional data show the use of Vectra DA can help inform treatment decisions and influence RA patient care. These, and other data, are being presented at the European League Against Rheumatism’s (EULAR) Annual European Congress of Rheumatology in Berlin, June 6-9, 2012.