MicroRNA: An Insight to miRNA-based microarrays, diagnostics and therapeutics Overview, Cambridge Healthtech Advisors

LONDON, Oct. 22, 2014 /PRNewswire/ -- This report covers the specifics of microRNA (miRNA) as it is a relatively new space in heavy pursuit of research due to its versatility and stability, properties that are unique to miRNAs compared to other RNA components. miRNA's non-coding nature and ability to affect genetic expression make it a novel candidate for use as a biomarker for a variety of diseases. This prompted the pursuit of miRNA-based microarrays and diagnostics for the advancement in therapeutic development. Furthermore there are a number of academic laboratories not only validating miRNAs, but also identifying them in a number of diseases and examining their molecular actions in the presence of other molecules. This report is broken up into several parts, highlighting miRNA in several areas of research.

After covering background information, the second and third parts of this report expand upon several microarrays and diagnostics for specific analysis and therapeutic development. Several companies featured in this section include:
• Affymetrix
• Exiqon
• Diamir
• Rosetta Genomics
• Eisai
• miRNA Therapeutics

Chapters within these sections feature company backgrounds and highlight proprietary technologies and platforms. Additionally, several advantages and limitations are also discussed. More significantly, these chapters are accompanied by interviews with company representatives, exclusively conducted for this report.

The fourth part of this report explores the academic, research and community perspectives. Although not developing diagnostics per se, academia is diligently investigating several aspects of miRNAs including their molecular properties for use as biomarkers for neurodegenerative diseases, diabetes, and even cancer. Universities and research institutes included in this area are:
• Stony Brook University School of Medicine
• Grand Valley State University
• Van Andel Research Institute

Also included in these sections are interviews with experts in leading research from these universities. From a community perspective, Dr. Argyropoulos, a Medical Affairs Consultant, provides insight to the rapidly growing space and rising opportunities.

Finally, the report concludes with an in depth analysis of survey results. With 152 researchers, these results provide an overall perspective of the research community, capturing a number of miRNA applications, challenges afloat in the industry, and miRNA mechanisms of study.

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SBH Diagnostics receives High-Complexity-CLIA Certification at Natick, Massachusetts Lab

BOSTON, March 4, 2014 /PRNewswire-iReach/ -- (Natick, MA) January 19, 2014. SBH Diagnostics announced receipt for CLIA certification and will offer the highly anticipated Picosensitive C-Peptide and Glucagon Assays in the US and Canada for diagnostic testing.

C-peptide has been used as a surrogate marker for insulin secretion in research and clinical diagnostics for many years.

The Picosensitive Assay called CPEP3, (exclusive Diagnostic-Use license from Mercodia, SA), is highly specific, precise and offers a low measuring range, not available with any other C-peptide assay on the market today. This assay allows many diabetic patients who may have been characterized as C-peptide negative based on the use of standard (less sensitive) methods to have their C-peptide levels accurately measured and this knowledge may affect treatment plans, inclusion in clinical trials, etc.

The value of this C-peptide assay has been highlighted by various groups including AACC publications (Clinical Laboratory News and Clinical Laboratory Strategies) and several publications by the Faustman Lab at MGH. The Pico Assay not only has important potential implications for patients and clinicians, it also allows for changes in inclusion criteria and monitoring during trials that assess treatments targeting those with long-term type 1 diabetes. This can also lead to intervention therapies to mitigate diabetes complications.

SBH Diagnostics will include the Picosensitive Assay in their CLIA Lab test portfolio, making it available to clinicians, in addition to those conducting clinical trials and companies involved with diabetes diagnosis, management and therapeutics.

"With CLIA certification, SBH Diagnostics now has the capacity to provide comprehensive solutions for clients working in clinical environments," stated Raphael Nir, President, SBH Diagnostics, Inc. "We are committed to providing clinical researchers, physicians, and patients with C-peptide testing results that ultimately lead to better diagnoses and more effective treatments. Because we deliver validated tests through our own CLIA laboratory, our partners have the ability to test clinical samples in a CLIA-certified setting, with appropriate standard operating procedures, Quality Management Systems, and robust documentation. The company's laboratory operates under Good Laboratory Practice, and all personnel follow strict confidentiality guidelines and undergo a rigorous training program including Health Insurance Portablilty and Accountability Act (HIPAA) practices".

SBH Diagnostics (SBHD) is an innovative Contract Research Organization and CLIA Lab dedicated to providing accurate and reproducible biomarker analysis services. We are focused on the commercialization of Laboratory Developed Tests (LDTs). In the SBH Diagnostics portfolio under CLIA auspices are the Pico-molar C-Peptide test, the highly-specific Glucagon Test and the EASy-Sjogren's test using the Automatic Simple Western process. SBHD is located in Natick, MA and is associated with SBH Sciences and GlycoZym.

Mercodia AB is a Swedish biotech company focusing on the development of high quality immunoassays within the field of metabolic disorders. Mercodia is a world-leading supplier to all major international markets and provides a professional scientific support system to develop novel applications for existing products and unique diagnostics for emerging markets. Mercodia has demonstrated compliance with "International Organization for Standardization (ISO) in 13485:2003, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes".

For further information, please contact:
Marvin A. Collin, Vice President
SBH Diagnostics
617-680-9792
macollin@sbhdiagnostics.com
www.sbhdiagnostics.com

Media Contact: Raphael Nir, SBH Diagnostics, 5086506218 Ext. 214, rnir@sbhsciences.com

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Concise Analysis of the International Molecular Diagnostics Markets

DUBLIN, Feb. 14, 2014 /PRNewswire/ --

Research and Markets

(

http://www.researchandmarkets.com/research/kkxpsb/molecular

) has announced the addition of the

"Concise Analysis of the International Molecular Diagnostics Markets"

report to their offering.

(Logo: http://photos.prnewswire.com/prnh/20130307/600769)

The technologies that constitute molecular diagnostics - like first-generation amplification, DNA probes, fluorescent in situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors, and molecular labels - are influencing the discovery of therapeutic molecules, the screening and diagnosis of patients, and the optimization of drug therapy. In the past few years, this rapidly evolving field has seen several fascinating developments.

This report describes the specific market segment of the in vitro diagnostics market known as molecular diagnostics and includes all of the generally accepted clinical analytical activities in use today. It examines the prevalent clinical-measurement devices, as well as their reagents and supplies as utilized in hospitals, clinics, large reference laboratories and doctor's offices. Diagnostic tests marketed primarily as over-the-counter are generally not included in this report, although there is inevitably some overlap.

Main Objectives of Report

1) Identifying viable technology drivers through a comprehensive look at platform technologies for molecular diagnostics, including probe-based nucleic acid assays, microarrays and sequencing;

2) Obtaining a complete understanding of the chief molecular diagnostics tests--i.e., predictive, screening, prognostic, monitoring, pharmacogenomic and theranostic--from their basic principles to their applications;

3) Discovering feasible market opportunities by identifying high-growth applications in different clinical diagnostic areas and by focusing on expanding markets, such as communicable diseases, cardiology and oncology;

4) Focusing on global industry development through an in-depth analysis of the major world markets for molecular diagnostics, including growth forecasts.

Key Topics Covered:

1. Overview

2. Introduction to Molecular Diagnostics and PCR Technology

3. Business Landscape for the Molecular Diagnostics Market Sectors

4. Overview of Clinical Molecular Diagnostic Platforms on the Market

5. Molecular Diagnostic Testing and Infectious Diseases

6. Cancer Detection Using Molecular Diagnostics

7. Genetics Testing in Molecular Diagnostics

8. Molecular Diagnostics Uses in Industrial Testing and Food Diagnostics

9. Bioterrorism and Molecular Diagnostics

10. Regulatory Requirements

11. Reimbursement Issues and Billing Landscape for Molecular Diagnostics Testing

12. Company Profiles

Companies Mentioned:

Abbott Laboratories AdvanDx Agendia Agilent Technologies Ambry Genetics Arcxis Biotechnologies Atlas Genetics AutoGenomics, Inc Beckman Coulter Becton, Dickinson and Company Bio-Rad Laboratories Biodesix Biohelix Corporation Cancer Genetics, Inc Celera (acquired by Quest Diagnostics) Cepheid Clarient, Inc (GE Healthcare) CombiMatrix Corporation Cytocell Technologies Ltd DiagnoCure, Inc Enzo Biochem Epigenomics Exact Sciences Corporation Exagen Diagnostics, Inc Exiqon GenMark Diagnostics, Inc Genera Biosystems Genomic Health Great Basin Corporation Hologic Illumina IntegenX InterGenetics, Inc LabCorp Life Technologies Corporation Luminex Myriad Genetics, Inc Nanosphere Nanostring Natera Neogenomics NetBio Nuvera Biosciences Orion Genomics PerkinElmer Genetics Progenika QIAGEN NV Roche Diagnostics Rosetta Genomics Ltd Seegene Sequenom, Inc Siemens Healthcare Diagnostics (Siemens) Spartan Bioscience Thorne Diagnostics Transgenomic TrimGen Trovagene, Inc Veredus Laboratories Veridex bioMérieuxFor more information visit http://www.researchandmarkets.com/research/kkxpsb/molecular

Media Contact: Laura Wood , +353-1-481-1716, press@researchandmarkets.net

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In Vitro Diagnostics Market - Global Industry Analysis, Size, Share, Growth and Forecast to 2018

DUBLIN, Feb. 14, 2014 /PRNewswire/ --

Research and Markets

(

http://www.researchandmarkets.com/research/ztk89b/in_vitro

) has announced the addition of the

"In Vitro Diagnostics Market - Global Industry Analysis, Size, Share, Growth and Forecast to 2018"

report to their offering.

(Logo: http://photos.prnewswire.com/prnh/20130307/600769)

In vitro diagnostics provide valuable information regarding the physiological and/or pathological state of the body and therefore are essential in making well-informed medical decisions. This report estimates the market for the in vitro diagnostics terms of revenue (USD million) for the period 2012 - 2018, keeping 2011 as the base year.

The in vitro diagnostics market is segmented by geography and market by products. The market estimation for the U.S. and two emerging economies (China and India) have also been included in the report.

The U.S., India and China in vitro diagnostics market is segmented by products into clinical chemistry IVDs, Immunoassay IVDs, diabetes testing IVDs, blood testing IVDs, molecular diagnostics, and other IVDs. The global market for in vitro diagnostics is segmented on the basis of geography into North America, Europe, Asia-Pacific and rest of the world (RoW) regions and this market is provided in terms of USD million.

This report includes the market shares of key players in 2011. Moreover, company profiles for some of the key players are included in the report in terms of company overview, financial overview, business strategies, recent developments and product portfolio. The major companies included in the report are Abbott Laboratories Inc., Alere Inc., Bayer AG, Becton Dickinson and Company, Biomerieux SA, Beckman Coulter Inc., Danaher Corporation, Gen-Probe Incorporated, Johnson and Johnson, Life Technologies Corporation, F. Hoffmann-La Roche Ltd., Siemens Healthcare (a division of Siemens AG) and Thermo Fisher Scientific Corporation.

Key Topics Covered:

1 Preface

2 Executive Summary

3 Market Overview

4 Global In Vitro Diagnostics Market, by Products (Qualitative information)

5 Global In Vitro Diagnostics Market, by Geography

6 U.S. In Vitro Diagnostics Market, by Products

7 China In Vitro Diagnostics Market, by Products

8 India In Vitro Diagnostics Market, by Products

9 Competitive Landscape

10 Company Profiles

Companies Mentioned:

Abbott Laboratories Inc Alere, Inc Bayer AG Beckman Coulter, Inc Becton, Dickinson and Company Biomerieux SA F Hoffmann-La Roche Ltd Gen-Probe Incorporated Johnson and Johnson Life Technologies Corporation Siemens Healthcare Thermo Fisher Scientific, Inc For more information visit http://www.researchandmarkets.com/research/ztk89b/in_vitro

Media Contact: Laura Wood , +353-1-481-1716, press@researchandmarkets.net

SOURCE Research and Markets

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