Singulex, Inc. Demonstrates Ultrasensitive “Sgx Clarity System"At AACC 2015

– Single Molecule Counting technology at the heart of development of a new in vitro diagnostics system; Company plans to commercialize in 2016 –

– Multiple presentations highlight the Company’s ultrasensitive immunoassay expertise –

– Singulex collaborator receives NACB Distinguished Abstract Award –

ALAMEDA, Calif., July 14, 2015 (GLOBE NEWSWIRE) -- Singulex, Inc., the developer of Single Molecule Counting (SMC™) technology for clinical diagnostics and scientific discovery, today announced that it will demonstrate the “Sgx Clarity™ System” in the company booth at the 2015 American Association for Clinical Chemistry (AACC) Annual Meeting from July 26 to 30, 2015 (booth number #2758). Utilizing Singulex’s proprietary second generation SMC™ technology, the fully-automated Sgx Clarity System is designed to detect low abundance biomarkers at levels down to femtograms/mL. The Sgx Clarity System is on track for full commercialization in Europe in 2016. In addition, the Company highlighted multiple scientific presentations that will take place at the AACC meeting that demonstrate the ultrasensitive protein detection of SMC technology using prototypes of the Sgx Clarity System (the Sgx Clarity System is in development; not available for commercial sale).

“We have made tremendous progress developing our in vitro immunoassay system that enables ultrasensitive detection of proteins used as clinical markers,” said Thomas Schlumpberger, PhD, Vice President Diagnostics at Singulex. “The advantage we expect to offer to physicians derives from the high precision and ultrasensitivity that the Sgx Clarity System will bring to clinical practice, shifting diagnostic modality into prognostic monitoring.”

The following poster presentations on July 29, 2015 from 9:30 a.m. to 5:00 p.m. will highlight early performance of the ultrasensitive protein detection of Sgx Clarity System:

Reference Range Study Using High Sensitivity cTnI Assay in Development for the Sgx Clarity™ Single Molecule Counting Platform (#B-004), J.Felberg, PhD, et al.

Endothelin Assay in Development for the Sgx Clarity™ Single Molecule Counting Platform Detects ET in Plasma and Discriminates Chronic Heart Failure from Healthy Donor Samples (#B-036), J.Felberg, PhD, et al.

BNP Assay in Development for the Sgx Clarity™ Single Molecule Counting Platform Demonstrates Increased Clinical Sensitivity Relative to a Conventional BNP Immunoassay (#B-037), J.Felberg, PhD, et al.

Additional poster presentations from studies using the Company’s first generation SMC technology will be shown on July 29 from 9:30 a.m. to 5:00 p.m. and are listed below.

High-sensitivity cardiac troponin I in a large community-based population at risk for cardiovascular disease (#B-006), Alan Wu, PhD, et al.

The relationship of inflammatory cytokines (IL-6, IL-17a and TNFa) to co-morbidities of cardiovascular disease in a large community-based patient population (#B-033), Alan Wu, PhD, et al.

Characterization of plasma Endothelin-1 in a large community-based patient population at risk for cardiovascular disease (#B-002), Alan Wu, PhD, et al.

Importantly, the abstract entitled High-sensitivity cardiac troponin I in a large community-based population at risk for cardiovascular disease won a National Academy of Clinical Biochemistry (NACB) Distinguished Abstract Award. Each year, the NACB, the professional arm of the American Association for Clinical Chemistry, acknowledges several posters to be presented with an NACB distinction. In Dr. Alan Wu’s poster, research that evaluated ultrasensitive cardiac troponin I (hs-cTnI) levels from 23,000 patients’ blood samples, processed and analyzed using Singulex’s SMC technology, highlights the impact of comorbidities on heart disease. The research concluded that differences in hs-cTnI levels exist between age and gender which may represent subclinical disease. Moreover, it may be possible to establish hs-cTnI concentrations for subgroups of patients that may more accurately define patients at risk for cardiovascular disease.

About Singulex, Inc.

Singulex is the developer of Single Molecule Counting technology for clinical diagnostics and scientific discovery. Singulex’s proprietary SMC™ technology enables physicians and scientists to detect biomarkers of disease that were previously undetectable. Powered by SMC technology, Singulex’s ultrasensitive lab testing services are transforming patient care from reactive disease treatment to proactive health management.

The Singulex Clinical Lab Testing Services consist of a CLIA-licensed and CAP-accredited laboratory that currently provides a comprehensive menu of advanced cardiovascular disease testing utilizing SMC technology. Singulex is currently developing the Sgx Clarity™System, a fully-automated in vitro diagnostics system that will bring the benefits of SMC technology to hospital and reference labs worldwide. For more information, please visit www.singulex.com.

CONTACT: Media: Denise Powell Red House Consulting 510.703.9491 denise@redhousecomms.com


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