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MentisCura to Deploy EEG Diagnostics for Dementia at China’s Largest Geriatric Hospital in 2014

MentisCura Diagnostics (www.mentiscura.com) and WanJiaYuan International Geriatric Hospital recently announced the signing of an agreement to implement MentisCura’s proprietary diagnostic tools to improve care for patients with CNS disorders.

Mentiscura’s diagnostics will be part of a state-of-the art technology suite being deployed at the WanJiaYuan International Geriatric Hospital, expected to open in June 2014. The hospital, based in Nanyang in the Henan province, will be a 120,000 square meter, 1200 bed campus, one of the largest facilities of its kind in the world to focus solely on setting new standards of quality of managed care for the elderly, with at least 200 beds dedicated to dementia patients. WanJiaYuan International Geriatric Hospital also aims to establish a leadership position in geriatric research through the development of a center of excellence attracting over 100 international experts.

“We are honoured to be associated with a project that is of an unprecedented scale, even by international standards. The high-throughput and non-invasive nature of our electrophysiological analysis makes it uniquely useful in a real world clinical setting, where physicians need to assess patients and make care decisions before these diseases have reached a late and untreatable stage. From a five-minute standard EEG recording, our powerful analytical systems are able to provide immediate diagnostic output, offering genuine clinical benefit and scalability for even the largest facilities,” said Kristinn Gretarsson, CEO of MentisCura.

“Our hospital is committed to addressing the growing burden of care associated with diseases of ageing. We are delighted to be collaborating with MentisCura to use its innovative clinical technologies to guide earlier, lower cost diagnosis. We believe that biomarkers of disease will increasingly play an important role in our diagnostic protocol for dementia, as well as monitoring of disease progression and treatment efficacy,” commented Dr. Jin-Jing Pei, MD, Chief Physician at WanJiaYuan International Geriatric Hospital.

MentisCura offers a complete, integrated service to hospitals and general practitioners through sampling, processing and analysis of patient EEG data. The MentisCura Analysis System is a CE marked diagnostic aid, based on advanced, proprietary EEG-biomarker technology platform that accurately correlates changes in electrophysiology to specific disease pathologies, based on the company’s comprehensive proprietary EEG database for dementia and cognitive disorders. The platform supports diagnoses for most common types of dementia, including Alzheimer’s disease and Lewy body dementia.

Source: MentisCura Diagnostics

Saladax Receives CLIA Laboratory Certification and Approval to Begin Clinical Laboratory Operations in Support of MyCare Portfolio

Saladax Biomedical, Inc., a privately held company developing novel diagnostic tests that individually optimize a patient’s exposure to chemotherapy, today announced it has been certified as a registered CLIA Laboratory from the Office of Clinical Standards and Quality (OCSQ), a division of The Centers for Medicare & Medicaid Services (CMS) that regulates laboratory testing performed on humans. The CLIA certification and approval marks a significant milestone for Saladax, allowing the company to begin clinical laboratory operations for the MyCare™ portfolio of products at its facilities located in Bethlehem, PA.

Saladax Biomedical Laboratories (SBL), a division of Saladax Biomedical, Inc., will initially offer testing services for chemotherapy exposure optimization assays including My5-FU™, MyPaclitaxel™ and MyDocetaxel™ in the U.S. SBL’s menu of testing services will expand to include more than a dozen new exposure optimization tests that are currently in development.

“This is a significant milestone for SBL as our CLIA laboratory operations are at the heart of our U.S. commercialization plan that will include an expanding suite of MyCare exposure optimization tests that we believe give cancer patients the edge they need with their therapy,” said Mark Myslinski, SVP and Chief Commercial Officer at Saladax Biomedical, Inc. “The SBL team did an outstanding job preparing our company for this milestone and it is illustrative of their preparedness for the commercial launch of the MyCare portfolio to oncologists in the U.S.”

Beginning on July 1, 2013, SBL will offer testing services for their initial chemotherapy exposure test portfolio, MyPaclitaxelTM, MyDocetaxelTM and the My5-FUTM test (previously OnDose) that is being transitioned from Myriad Laboratories. The MyCare technology platform offers, rapid, robust and cost-effective blood tests for patient-specific chemotherapy dose optimization.

As a simple blood test, MyCare products will provide oncologists with vital information to determine the optimal chemotherapy dose required to maximize effectiveness and limit toxicity for their patients on an individual basis.

About Saladax Biomedical, Inc.
Saladax Biomedical develops novel diagnostic assays for the practical delivery of personalized medicine. The company’s proprietary line of MyCare™ assays improves the efficacy of existing drugs by optimizing the dose administered for each individual patient. The initial focus of Saladax is oncology, with a portfolio of 13 chemotherapy drug assays in various stages of development. The initial portfolio of three assays is currently offered to the oncology community in markets around the world.

The company’s MyCare technology platform is broad and flexible, enabling wide application in many therapeutic categories. This technology also enables Saladax to serve as a valuable partner to pharmaceutical and biotechnology companies in the development of companion diagnostics (CDx), addressing multiple risks and challenges encountered in drug development.

Headquartered in Bethlehem, Pennsylvania, Saladax was founded in 2004 and is ISO 13485:2003 certified.

Source: Saladax Biomedical

Matrix-Bio Signs Metabolomics Biomarker Licensing Agreement with Quest Diagnostics for Development of Breast Cancer Recurrence Test

Matrix-Bio Inc., a diagnostics company that uses metabolite profiling to detect cancer and other diseases, recently signed an exclusive global licensing and marketing agreement for metabolomic biomarkers with Quest Diagnostics (NYSE: DGX).

Pfizer-KineMed Collaboration Extends to Target Novel Diabetes Pathways

KineMed Inc. (www.kinemed.com) today announced the renewal of a non-exclusive research collaboration with Pfizer Inc. (NYSE: PFE) for the advancement of novel approaches towards metabolic disease, in particular Type II Diabetes. The collaboration will employ KineMed’s unique dynamic proteomics technology platform to map the impact of potential drug candidates on specific metabolic pathways.

Diabetes is an emerging global healthcare epidemic with an estimated 347 million people affected, according to the WHO. Diabetes is predicted to become the seventh leading cause of death in the world by the year 2030 and total deaths from diabetes are projected to rise by more than 50% in the next 10 years.

In the United States Type II diabetes affects over one quarter of Americans over the age of 65. Diabetes is a major cause of heart disease and stroke, and is now also the leading cause of kidney failure, non-traumatic lower-limb amputations and new cases of blindness among adults.

Despite 50 years of drug research, over 60% of patients remain unresponsive to current therapies, requiring novel approaches to address fundamental metabolic processes in diabetes.

“We are very pleased to announce the renewal of this ongoing partnership in an important area of medicine that affects so many Americans. Powerful discovery and investigative abilities of novel disease pathways are key strengths of our translational platform,” said Dr. Scott Turner, Executive Vice-President, R&D at KineMed. “We look forward to continuing to work with Pfizer to accelerate and rapidly de-risk the advancement of novel compounds in pre-clinical and clinical trials.”

Source: Business Wire

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