Frost & Sullivan Recognizes Singulex for Erenna® Immunoassay System

2009-Jun-15

Jake Wengroff
210.247.3806
jake.wengroff@frost.com

Enabling High Resolution Monitoring of Drug Efficacy and Safety

Link to PRNewswire

MOUNTAIN VIEW, Calif. — June 15 2009 — Based on its recent analysis in the area of immunoassay technologies for biomarker measurement, Frost & Sullivan recognizes Singulex, Inc. with the 2009 North American Frost & Sullivan Award for Technology Innovation for pioneering the Erenna Immunoassay System. This system incorporates single molecule counting (SMC) technology into next-generation immunoassays, significantly impacting early disease management and patient monitoring.

Pharmaceutical partners are using this system to implement advanced biomarker monitoring programs that address drug safety and efficacy. The Erenna system offers the unique advantage of high-resolution monitoring of key disease biomarkers due to its unrivaled sensitivity and precision, which can enable early decision making and reduce the over-all cost of drug development. Through collaborative efforts, Singulex is helping to deliver better medicine with an unsurpassed safety/efficacy profile in a cost-effective manner.

The Erenna Immunoassay System simplifies clinical trial management by bridging the gap between preclinical and clinical assessment of protein biomarkers for disease. The system offers full flexibility, providing users a broad assay menu and custom assay development services to discover the effect of therapeutic intervention on biological pathways of interest.

“In deploying the high sensitivity platform, the company has developed a broad menu of novel ultrasensitive immunoassays that offer a better understanding of early disease processes and the impact of therapeutic interventions by measuring biomarker levels in blood samples,” observes Philippe Goix, CEO. “Singulex is also building on its diagnostic business by offering our proprietary Molecular Cardiac Troponin-I (cTnI) testing services in our CLIA laboratory for early detection and monitoring of cardiovascular disease risk.”

The Erenna Immunoassay System is a simple, easy-to-use bench-top analytical instrument with ready-made reagents that provides high-resolution results directly from biological specimens such as serum or plasma. The system includes data management software and can be integrated into an existing clinical laboratory workflow. The system can also be integrated with automated robotic handling units to provide high throughput capabilities for biomarker quantification and validation.

“The technology behind the Erenna system comprises two important stages: a modified microparticle (MP)-based sandwich immunoassay followed by a single molecule counting technology,” explains Frost & Sullivan Healthcare Industry Analyst Pramodh Ishwarakrishnan. “The system combines a 384-well plate format for sample analysis, capillary flow, laser-induced fluorescence, and a highly sensitive detection optics module.”

Increased sensitivity and precision are essential for robust measurement of disease biomarkers, and the Erenna system enables high resolution monitoring by accurately quantifying minute changes in biomarker concentration in patient specimens over time. The Erenna system measures each fluorescent-labeled detection antibody as an unique digital event separate from the background fluorescent signal, unlike conventional analog systems that count the total light together with background. Thus, the system offers enhanced specificity, sensitivity, and precision by 1 to 2 logs over existing plate-based methods.

Each year, Frost & Sullivan presents this award to the company (or individual) that has carried out new research that has resulted in innovation(s) that have or are expected to bring significant contributions to the industry in terms of adoption, change, and competitive posture. This award recognizes the quality and depth of a company’s research and development program as well as the vision and risk-taking that enabled it to undertake such an endeavor.

Frost & Sullivan’s Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research in order to identify best practices in the industry.

About Singulex, Inc.

Singulex, Inc. manages risks by answering critical health questions about disease and therapeutic intervention utilizing cutting edge immunodiagnostic products. Singulex has pioneered technology that can quantitatively detect single molecules such as proteins and metabolites in complex biological samples. The technology embedded in the Erenna System extends the dynamic range of any immunoassay by orders of magnitude, allowing drug developers to use biomarkers to measure drug efficacy, safety, and disease progression. The company also focuses on advancing industry-leading sample analysis and assay development services. Singulex has assembled a team of scientists who are experts in the field of immunoassay development to ensure that all products are manufactured to the highest standards.

About Frost & Sullivan

Frost & Sullivan, the Growth Partnership Company, enables clients to accelerate growth and achieve best in class positions in growth, innovation and leadership. The company's Growth Partnership Service provides the CEO and the CEO's Growth Team with disciplined research and best practice models to drive the generation, evaluation, and implementation of powerful growth strategies. Frost & Sullivan leverages over 45 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from more than 35 offices on six continents. To join our Growth Partnership, please visit http://www.frost.com