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Archives for April 2013

Molecular Response Launches TargetXTM Platform for Rapid Discovery & Validation of New Oncology Targets

Molecular Response recently announced the launch of its TargetX platform for rapid discovery and validation of new oncology targets. The program provides partners with access to the world’s largest bank of living tumor specimens, matched genomic database, and in vivo/ex vivo patient derived tumor models for validation. The integrated platform enables investigators to do in days what used to take months.

Target discovery and validation in oncology has largely relied on molecular and functional studies performed in cell lines. Recent advances in genomics have now created large databases based on well-characterized tumor tissue, which has enabled direct investigation of patient tumors for novel targets. Following these discoveries, it is routine to perform functional studies in cell line-based systems; however, it is often challenging to find a relevant cell line model and if found, there are often numerous factors which confound biology when using historical cell lines for functional studies. The result can be a process which takes considerable time and does not readily translate to clinical relevance.

“TargetX is the largest scale genomic database matched to living patient-derived tumor models,” said Dr. Mohit Trikha, CSO of Triphase Accelerator and founder of Drug Design Corp. “We plan to access it for our drug pipeline development and biomarker identification; having everything in one place allows us to do in days what used to take months. Additionally, we can now work with living patient derived tumor samples rather than cultured cell lines.”

The platform relies on Molecular Response’s proprietary bank of more than 144,000 patient derived tumor cells, of which nearly 400 tumors have been genomically characterized and databased for target discovery studies. The database is growing, but currently features the following cancer indications: colon carcinoma, NSCLC, melanoma, ovarian carcinoma, prostate cancer and Non-Hodgkins Lymphoma. Upon discovery of a novel target, tumors of interest are immediately implanted into mice to perform functional studies in direct patient derived models–either in vivo or ex vivo. Molecular Response currently has more than 60 such patient derived xenograft models established for in vivo studies.

“We continue to focus on the use of patient derived models, both in vivo and ex vivo, for advancing oncology drug development,” said Thomas Broudy, CSO of Molecular Response. “Everybody would like to perform studies in the patient derived tumor setting starting as early as possible, but without the resource to do so, it’s nearly impossible. TargetX now enables you to do that.”

Molecular Response presented results from the TargetX platform at the AACR meeting; the company has identified a novel kinase target for potential therapeutic development. They investigated prevalence of target overexpression across 7 cancer indications, and identified melanoma as a clinical indication of high interest. Growth characteristics from patient tumors featuring high kinase gene expression vs. low expression were examined to help characterize the role of this target in oncology disease progression. Functional studies in these patient derived models to further validate the novel kinase are ongoing, as is a small molecule and antibody-based therapeutic development program.

Source: Business Wire

Cardiac IVD Company Critical Diagnostics Expands Its Global Presence

Critical Diagnostics, a U.S.-based biomarker company focused on cardiovascular diseases, and makers of the Presage® ST2 Assay, recently announced several new European distribution deals.
The Company has chosen as exclusive distributors (in alphabetical order), Assut Europe in Italy and San Marino, Biochemmack in Russia, Cruinn Diagnostics in Ireland, IVD Bulgaria in Bulgaria, Life Biomedical in the UK, Maritim Ltd. In Slovenia, Croatia and Serbia, Nordic Diagnostica in Sweden, and Sopachem in Benelux.

“In addition to established distributor relationships in France, Germany and Spain, Portugal and Turkey, these new partnerships continue to broaden our presence across Europe,” notes Richard Hughes, Vice President, Business Development Europe for Critical Diagnostics. “With our extensive network of distributor partners all across the Asia Pacific region, we are truly a global company, prepared to meet the needs of the 23 million heart failure patients that suffer from this serious disease.”

Source: Critical Diagnostics

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

Atherotech Diagnostics Lab Expands Heart Disease Atherotech Diagnostics Lab Expands Heart Disease Risk Assessment with AspirinWorks® Test

Atherotech Diagnostics Lab, a leading clinical reference laboratory specializing in cardiometabolic testing and disease management solutions, recently launched the AspirinWorks® Test to complement its menu of cardiovascular disease risk assessment tests.

More than 1 million Americans experience new or recurrent heart attacks each year. These at-risk individuals are candidates for aspirin therapy and should be tested for the presence or absence of the therapy’s effect. The AspirinWorks Test is used to determine levels of 11‑Dehydro Thromboxane B2 (11dhTxB2) in human urine, which aids a physician in the determination of aspirin effect.

“The AspirinWorks Test maximizes the value of our VAP Lipid Panel and accompanying line of cardiometabolic disease diagnostics and management tests,” Atherotech CEO Michael Mullen said. “This offering is strategically aligned with our company’s mission to proactively manage risk and guide therapy to help improve patient outcomes.”

Aspirin therapy works on blood platelets to decrease levels of thromboxane A2 (TxA2), a powerful stimulator of platelet aggregation. Lower thromboxane levels and decreased platelet aggregation means less chance of developing a blood clot, and therefore, less chance of a heart attack or stroke. However, studies have shown that for several reasons, up to 25 percent of individuals do not get the expected beneficial effect of aspirin.

The AspirinWorks Test identifies those individuals who have elevated thromboxane levels despite taking a daily aspirin dose.

“The added information from the AspirinWorks Test will help provide a more accurate and complete evaluation of a patient’s cardiovascular health,” Atherotech Chief Medical Officer Michael Cobble, M.D., said. “Assessment of the chemical marker for platelet aggregation facilitates a strategic, scientifically validated approach to maximizing the value of aspirin therapy and minimizing the risk of heart attack and stroke.”

The AspirinWorks Test has been clinically validated through extensive research and numerous well-designed and well-powered clinical trials. The AspirinWorks Test is FDA cleared and used to test and guide treatment for hundreds of thousands of patients each year worldwide.

Atherotech provides a full complement of more than 60 routine and specialty diagnostic tests, including its patented VAP® Lipid Panel to help physicians establish the most effective course of treatment from a single source.

Source: Atherotech Diagnostics

Presage Biosciences Announces First Patient in Clinical Trial of CIVO™ Precision Oncology

Presage Biosciences, a leader in precision oncology, recently announced the initiation of a clinical trial and the first patient use of CIVO™, the company’s precision oncology platform designed to improve treatment decisions for cancer patients. The single arm, non-therapeutic, observational study, being conducted at Fred Hutchinson Cancer Research Center and Seattle Cancer Care Alliance, is intended to evaluate the feasibility of Presage’s CIVO in assessing lymphoma response to multiple microinjected candidate chemotherapy agents.

“Results from this initial study will assess the potential of CIVO to guide personalized clinical treatment for lymphoma patients,” said Richard Klinghoffer, Ph.D., Vice President of Research & Development at Presage Biosciences. “CIVO is designed to enable analysis of the potential therapeutic effect of multiple drugs simultaneously following precise delivery of each agent to a distinct location on the patient’s tumor. By employing this technology we hope to discern which drugs induce a localized anti-tumor response, indicative of therapeutic effect, prior to systemic administration of chemotherapy.”

The trial will enroll up to 12 patients with either newly diagnosed lymphomas who have not yet received treatment or relapsed lymphoma previously treated with one or more agents in the R-CHOP chemotherapy regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone). Patients’ lymphomas will be microinjected with up to four drugs comprising rituximab, vincristine, doxorubicin and prednisolone. Twenty-four hours later, the lymph node of interest will be removed and analyzed for target engagement and tissue response.

More information about this study, including additional eligibility criteria and contact information, can be found on clinicaltrials.gov. Study participants are not expected to benefit medically from participation or to directly benefit from the data generated in this feasibility study. None of the data will be released to the patient or treating physician in a manner that could be used to make treatment decisions. Patients may contact Jennifer Lindquist, Patient Care Coordinator / Lymphoma – Intake Office at Seattle Cancer Care Alliance, jlindqui@seattlecca.org or 206-288-6202 for more information.

“When a patient learns they have cancer, they want effective drugs that cause as little toxicity as possible. An expert panel from the American Society for Clinical Oncology found that previous attempts to predict cancer sensitivity to therapeutic agents using cancer cells grown in tissue culture dishes have not helped the way we hoped they would,” said Oliver W. Press, M.D., Ph.D., a member of the Clinical Research Division at the Fred Hutchinson Cancer Research Center, Professor of Medicine at the University of Washington and the Principal Investigator for the study. “Oncologists and patients are eager for a reliable method to assess cancer drug sensitivity or resistance in the patient’s own tumor. We look forward to evaluating the Presage’s CIVO precision oncology platform and gathering patient data to evaluate the potential of this innovative approach.”

Source: Presage Biosciences