Singulex Opens European Office and Advances IVD System Evaluation

Singulex, one of the leaders in Next Generation Immunodiagnostics powered by Single Molecule Counting technology, has announced the opening of the first international office of Singulex International AG, in Basel Switzerland, and the installation of the investigational use only Sgx Clarity^TM System at the University of Manchester. These two events are significant milestones on the path toward commercialization of the Company’s SMC^TM powered products in Europe and across the globe, paving the way for increased access to more definitive clinical results and the ability to lower cost across the health care system.

Singulex has entered into an agreement with the University of Manchester in the United Kingdom to install their Sgx Clarity System as part of the Company’s ongoing clinical evaluation ahead of an anticipated European CE-Mark declaration in 2017. The Sgx Clarity System, a fully-automated in vitro diagnostics platform currently under development, is designed to bring the benefits of Singulex’s SMC technology to hospital and reference labs worldwide.

UK Medical Research Council-funded Manchester Molecular Pathology Innovation Centre is utilizing the Sgx Clarity System to evaluate SMC powered high-precision cardiac troponin assays to guide disease rule-out in the high cost and high patient risk area of cardiac disease.

“The ability to access SMC technology in our own facility via the Sgx Clarity System is extremely valuable,” said Prof. Anthony Freemont, Director of the Manchester Molecular Pathology Innovation Centre at the University of Manchester. “Our clinical evaluation of the Sgx Clarity System is examining the economic impact of ruling-out coronary artery disease, with a view to the utility in the acute and community-based settings. We’re also looking at potential future applications in AMI, oncology and infectious disease. Already, I can see broad potential for clinical applications and the ability to inform physician decisions and help bring economic benefits to the broader health setting.”

The collaboration with the University of Manchester marks the third placement of the Sgx Clarity System in Europe for clinical evaluation. Evaluation sites at St. George’s Hospital in London, U.K., along St. Pau Hospital, Barcelona, are all collaborating to guide the assessment, application and data collection for the Sgx Clarity System and future clinical applications.

“High-sensitivity testing of cardiac troponin is a game-changer for the diagnosis and treatment of cardiac disease,” said Prof. Rick Body, from the University of Manchester and Professor at the Royal College of Emergency Medicine. “We need high precision and sensitivity assays to definitively rule-out disease. Assessing cardiac biomarkers at levels previously unattainable will help physicians rule-out disease in patients suspected of having cardiovascular disease and hence focus on the patients with the greatest risk and need, while also helping to reduce the overall cost and risk for the patient and the health system.”

As part of the initiative to build a strong presence in Europe, Singulex is also pleased to announce the opening of the first office of Singulex International AG in Basel, Switzerland. Supporting Singulex’s worldwide headquarters in Alameda, California, USA, the Basel office will guide product commercialization of Singulex’s SMC-powered technology in Europe and across the globe.

“2017 will be a major year for our Company, with the anticipated CE-Mark and launch of Sgx Clarity System in Europe and advancement of clinical evaluations to support clearance in the US and around the globe,” said Guido Baechler, president and CEO of Singulex, Inc. “It is critical for our company that we establish a strong presence in the European market from which we can lead product sales, clinical education and after-sales support for our products. We are shaping the next generation of immunodiagnostics, so close collaboration with our clinical partners will guide our success and continued growth in Europe and markets across the globe.”

Already staffed and open for business, Singulex International AG will guide market access, commercialization, training and support of the Sgx Clarity System in Europe in 2017, following anticipated regulatory clearance, and all markets outside of the United States in future years.