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Singulex Announces Issuance of U.S. Patents for Single Molecule Detection of Protein Biomarkers and Key Biomarker for Cardiac Risk Monitoring

Tuesday, December 14, 2010

Alameda, CA -- Singulex, Inc., the leader in high-definition immunodiagnostic technology, announced today that the U.S. Patent & Trademark Office has issued two patents related to the Company’s Erenna® Technology, for the quantitative measurement of single molecules in complex biological samples. The patented technology enables the Erenna Immunoassay System to integrate single molecule counting into microparticle-based immunoassays that dramatically improve assay sensitivity.

U.S. patent 7,572,640 covers the flow system methods applied in the Erenna Technology, which enable monitoring of very low abundance biomarkers, as well as confer the ability to interrogate these biomarkers to discover their relationship in human disease. The unparalleled sensitivity of the Erenna Immunoassay System allows discovery around previously intractable disease biology and enables an understanding of complex biomarker associations. Pharmaceutical and biotechnology partners are using the Erenna Immunoassay System in their therapeutic programs to better understand the efficacy, safety and pharmacokinetics of therapeutics.

A second U.S. patent, 7,838,250, issued to Singulex covers the measurement of Cardiac Troponin-I (cTnI) at low abundance concentrations. The Erenna Technology enabled the discovery of the clinical utility of certain changes in cTnI levels in the blood relative to cardiac disease damage and progress versus normal individuals. The patent covers technology-independent methods for the measurement of cTnI in a reference range of approximately 1-10 pg/mL. Elevations in cTnI concentration above this reference range, but below the detection limit of other technologies, have been shown to be associated with cardiac damage. Singulex is building on its diagnostic business by offering cTnI testing services in its CLIA laboratory for early detection and monitoring of cardiovascular disease risk.

“Our latest patents enhance the overall commercial profile of our Erenna Immunoassay System and strengthen Singulex’s valued IP portfolio in advanced immunodiagnostics,” said Singulex CEO Philippe Goix. “We will continue to leverage this technology to expand our broad menu of novel ultrasensitive immunoassays that improve understanding of early disease processes. We are pleased that our technology has enabled our pharmaceutical partners to implement advanced biomarker monitoring programs that address drug safety and efficacy. We are excited about the application of our latest technology advances to further enhance our cardiovascular disease risk assessment and monitoring program.”

The Erenna Immunoassay System offers the unique advantage of high-definition monitoring of key disease biomarkers due to its unrivaled sensitivity and precision, which can enable early decision-making and reduce the overall cost of drug development. Through collaborative efforts, Singulex is helping to deliver better medicine with an unsurpassed safety and efficacy profile in a cost-effective manner.

About Singulex, Inc.

Singulex, Inc. helps manage patient health 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, including proteins and metabolites, in complex biological samples. The technology embedded in the Erenna Immunoassay System extends the dynamic range of immunoassays by orders of magnitude, allowing drug developers to use biomarkers to measure drug efficacy, safety, and disease progression. The company provides advanced CLIA-laboratory patient testing as well as industry-leading sample analysis and assay development services.

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