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Venaxis’ APPY1 Test Passes Futility Analysis in Pivotal Clinical Study

Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company focused on obtaining FDA clearance and commercializing its CE Marked APPY1 Test, a rapid, multiple biomarker-based assay for identifying patients that are at low risk for appendicitis, recently announced that the external Data and Safety Monitoring Board (DSMB) created as part of the Company’s pivotal clinical trial for the APPY1 Test has recommended continuation of the pivotal clinical trial, based upon completion of the first of two futility analyses included in the clinical trial design. Venaxis will host a conference call and webcast tomorrow morning, July 16, 2013, at 8:30 a.m. ET, to discuss the DSMB’s recommendation and to provide a general corporate update.

Venaxis’ APPY1 Test Passes Final Futility Analysis in Pivotal Clinical Study

Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company focused on obtaining FDA clearance for and commercializing its CE Marked APPY1 Test, a rapid, multiple biomarker-based assay for identifying patients that are at low risk for appendicitis, recently announced that the external Data and Safety Monitoring Board (DSMB) created as part of the Company’s pivotal clinical trial for the APPY1 Test has recommended continuation of the pivotal clinical trial, based upon completion of the second and final futility analysis included in the clinical trial design.

New Workflow to Provide Scientists with Tools That Enable Single Cell Analysis for Oncology, Immunology and Stem Cell Research

NanoString Technologies, Inc. (NASDAQ: NSTG), a provider of life science tools for translational research and molecular diagnostic products, and BD Biosciences, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, recently announced a collaboration agreement for the development of a single cell isolation and analysis workflow.

Under the agreement, the companies will jointly develop a workflow using the NanoString nCounter®Analysis System (including the nCounter Single Cell Assay) and the BD Flow Cytometry cell sorter product line (emphasizing the new BD FACSJazz™ Cell Sorting System). The combined workflow will enable single cell gene expression analysis for research applications such as oncology, immunology and stem cell research. Collaboration activities will also include the development of materials documenting the workflow protocol, as well as co-hosting meetings and webinars to educate scientists about the single cell workflow.

“Maximizing both the quantity and quality of data that can be extracted from a single cell is critical to the emerging field of single cell biology. The nCounter Analysis System can analyze entire gene pathways and provides a highly precise and reproducible digital output, making it ideally suited to the task,” said Brad Gray, President and Chief Executive Officer, NanoString Technologies. “The nCounter Analysis System and the BD FACSJazz Cell Sorting System can together provide a powerful and efficient workflow for single cell gene expression analysis.”

“Our collaboration with NanoString Technologies furthers BD’s commitment to providing researchers advanced solutions for cell analysis and isolation,” said Alberto Mas, President, BD Biosciences. “We believe this new sorting workflow will complement the recent and very rapid advances in genomic studies that value the requirement for greater sample integrity for critical single cell analysis.”

NanoString Technologies’ nCounter Analysis System is a multi-application digital detection and counting system with a highly automated and simple workflow. The company’s Single Cell Gene Expression application provides researchers with a highly flexible and sensitive approach to discovering differences in cell-to-cell gene expression profiles.The application enables up to 800 genes to be detected in a single tube.

The BD FACSJazz Cell Sorting System is capable of identifying, characterizing and isolating single or multiple cells – from complex or extremely rare cell populations – and depositing them in 96 and 384 well plates to provide rapid cell isolation, tracking and identification throughout the process.

For more information about NanoString Technologies, the nCounter Analysis System and the nCounter Single Cell Assay, please visit www.nanostring.com.

For more information on the BD FACSJazz Cell Sorting System, please visit www.bdbiosciences.com/facsjazz.

Source: BD Biosciences

Spinal Fluid Biomarkers of AD and Brain Functional Network Integrity on Imaging Studies

Both Aß and tau pathology appear to be associated with default mode network integrity before clinical onset of Alzheimer disease (AD), according to a study by Liang Wang, M.D., and colleagues at Washington University in St. Louis, Missouri.

Accumulation of Aß and tau proteins, the pathologic hallmarks of AD, starts years before clinical onset. Pathophysiological abnormalities in the preclinical phase of AD may be detected using cerebrospinal fluid (CSF) or neuroimaging biomarkers, according to the study background.

A total of 207 older adults with normal cognition participated in the cross-sectional group study. Researchers examined the relationship between default mode network integrity and cerebrospinal fluid biomarkers of Alzheimer disease pathology in cognitively normal older individuals using resting-state functional connectivity magnetic resonance imaging.

According to the study results, decreased cerebrospinal fluid Aß42 and increased cerebrospinal fluid phosphorylated tau181 were independently associated with reduced default mode network integrity, with the most prominent decreases in functional connectivity observed between the posterior cingulate and medial temporal regions (regions of the brain associated with memory). Observed reductions in functional connectivity were unattributable to age or structural atrophy in the posterior cingulate and medial temporal areas.

Study: Cerebrospinal Fluid Aβ42, Phosphorylated Tau181, and Resting-State Functional Connectivity [JAMA Neurology]

Source: EurekAlert!

VirtualScopics Completes 6 week Analysis of Phase III Breast Cancer Study

VirtualScopics, Inc. (NASDAQ: VSCP), a leading provider of quantitative imaging, recently announced that they have completed analysis of a greater than 10,000 scan Phase III breast cancer study one week ahead of the six week contract period of the study utilizing a recently launched 3rd generation analysis platform.

Details of this new system include:

  • Significant advances in radiology productivity enabling shorter timelines and reduced cost.
  • An automated case check feature that validates radiologist input according to the technical details of analysis criteria and detects errors in real-time reducing rework and enhancing first pass quality.
  • A one-touch, automated data management system ensuring complete data integrity from receipt to delivery reducing the need for data reconciliation and allowing for compressed timelines, a critical element for late phase studies.
  • Significant enhancements in our Phase III capacity and quality control processes, facilitating increased revenue growth, client satisfaction, and financial return.

Jeff Markin, president and chief executive officer of VirtualScopics stated, “We are extremely pleased to have finished this very large time compressed study ahead of schedule. The analysis represented in this study is the last remaining piece of efficacy data required for the client’s submission to the regulatory authorities. As such, it was very important for us to complete this with the highest possible quality at or ahead of schedule.” He further stated, “This study, along with regularly contracted work completed during the same period, represented a greater than 300% increase in the quantity of data ever processed by the company in a five week timeframe. I am very proud of our team for completing this ahead of schedule including a results file with over 2 million records with no data errors identified by the client or their data management company.” He concluded, “As we process and pursue additional large studies like this our personnel, software, and systems positions us very well from a client and financial perspective.”

Source: PR Newswire