Singulex  

1701 Harbor Bay Parkway
Suite 200
Alameda,  CA  94502

United States
http://www.singulex.com
  • Booth: 1329

Profile

Singulex is the revolutionary immunodiagnostics company focused on delivering ultra-sensitive diagnostics and absolute certainty to deliver the BioRemarkable power to rule out disease. Singulex’s proprietary Single Molecule Counting technology detects biomarkers of disease that were previously undetectable to give physicians and scientists unprecedented insight into health status and the ability to identify the presence—and absence—of disease. For more information, please visit www.singulex.com


 Press Releases

  • Alameda, CA – March 23, 2017 – Singulex, Inc., the creator of Single Molecule Counting immunodiagnostic technology, is expanding clinical evaluation of the Sgx ClarityTM system at clinical research sites across Europe. With multiple clinical research studies currently underway at a site in Spain and two sites in the United Kingdom, leading researchers and cardiologists across Europe recognize the potential value and utility of the in vitro diagnostics (IVD) platform to help bring greater sensitivity, accuracy and utility to understanding disease status, particularly in heart disease.

    “Singulex’s proprietary Single Molecule Counting technology is already proven to allow greater analytical and clinical sensitivity and understanding of how biomarkers can guide health status,” said Dr. Jorge Ordonez-Llanos, Professor of Clinical Biochemistry at Hospital de Sant Pau, Barcelona and former chair of the International Federation of Clinical Chemistry (IFCC) Task Force on Clinical Applications of Cardiac Biomarkers. “With that clinically proven power, researchers can explore the potential for clinical use. At my site in Barcelona, we’ve already demonstrated the improved detection limit, analytical precision and functional sensitivity and are expanding clinical research studies to explore applications of the cardiac troponin-I (cTnI) biomarker to better manage patients and bring cost savings to our hospital.”

    The Sgx Clarity system, currently under development and not yet available for sale, is an IVD platform designed to bring the benefits of Singulex’s Single Molecule Counting technology to hospital and reference labs worldwide.

    “Utilizing the Sgx Clarity system at St. George’s University in London, we have observed performance of the investigational use only Sgx Clarity cTnl assay at the level which we believe meet the European Society of Cardiology (ESC) guidelines for the management of acute coronary syndromes, specifically to rule-in and rule-out patients,” said Professor Paul Collinson, Professor of Cardiovascular Biomarkers at St. George’s University Hospitals in London, UK. “In our view this validates the utility of Singulex’s IVD platform and reinforces the opportunity it may present to our understanding of heart and total health status.”

    Led by world-renowned clinical researchers in the fields of cardiology, immunodiagnostics and molecular pathology, the Sgx Clarity system is active in clinical evaluation at the following sites across Europe:

    Barcelona, Spain: Hospital de Sant Pau – In collaboration with Professor Jorge Ordonez-Llanos, the Sgx Clarity system has been in-place in Barcelona since May 2016. A research study evaluating samples from 150 patients – now expanded to 300 – is utilizing Sgx Clarity cTnI assay to determine whether cardiac status in individuals with chest pain assessed in the emergency room could avoid complementary explorations of stress test, angio-CT or MRI. Additional clinical research studies are planned around the concept of ruling out the presence of CVD in those suspected of having it and subsequently guide appropriate utilization of supplementary procedures which could result in enhanced patient management and cost savings.

    Professors Jorge Ordonez-Llanos and Juan Cinca-Coscollola, lead of the Cardiology Department at Hospital de Sant Pau, will evaluate the role of Sgx Clarity cTnI assay on a multimarker strategy for prognosis of readmissions in acute heart failure patients. The project is included on the Spanish Network of Acute Heart Failure, a nation-wide study sponsored by the Spanish Ministry of Health.

    London, United Kingdom: St. George’s University – Professor Paul Collinson, Professor of Cardiovascular Biomarkers, has completed analytical evaluation of the Sgx Clarity system’s performance and with Professor Ordonez-Llanos plans on presenting the findings at an upcoming scientific Congress. Dr. Collinson will go on to test the WESTCOR study to investigate the ability of high-sensitivity cardiac troponin assays to rule out the presence of coronary disease in patients that present with suspected acute coronary syndrome.

    Manchester, United Kingdom: University of Manchester – Professor Anthony Freemont, Director of the Medical Research Council-funded Manchester Molecular Pathology Innovation Centre at the University of Manchester, and Professor Richard Body, Professor of the Royal College of Emergency Medicine, are testing the Sgx Clarity cTnI assay in the Supersensitive Troponin for Admission Reduction (STAR) Study. The STAR study is evaluating whether use of Sgx Clarity cTnI assay on the Sgx Clarity system can enable doctors to rapidly rule out acute coronary syndrome with just one blood test, avoiding unnecessary hospital admissions and bringing substantial cost savings to the NHS health care system.

    In addition to these three active sites, Singulex is engaged with researchers at other sites across Europe with a goal to expand Sgx Clarity system installation and evaluation. Potential sites in Italy, Germany, Norway and further sites in Spain and the UK will help expand the understanding of utility and value of the Sgx Clarity system.

    Singulex is committed to extensive clinical validation of its Single Molecule Counting technology and its application via the Sgx Clarity system, its CLIA-licensed and CAP-accredited laboratory and future technology platforms in development. The Company anticipates additional peer-reviewed publications and presentations, expanding on the more than 130 peer-reviewed publications to-date, from the current investigations in Europe, along with future application in heart disease, infectious diseases, oncology, inflammation, and other high-cost and highly-prevalent diseases.

    About Singulex, Inc.
    Singulex is the next generation immunodiagnostic company developing Single Molecule Counting technology for clinical diagnostics and scientific discovery. Singulex’s proprietary Single Molecule Counting technology enables physicians and scientists to detect biomarkers of disease that were previously undetectable. Powered this 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 disease testing utilizing Single Molecule Counting technology. Singulex has developed the Sgx Clarity system, a fully-automated IVD system that will bring the benefits of Single Molecule Counting technology to hospital and reference labs worldwide. For more information, please visit www.singulex.com.

    Contact:
    Jessica McCarthy. Vice President, Global Marketing & Communications
    Singulex, Inc. 

    Tel: +1 (510) 995-3855
    J.McCarthy@singulex.com

  • Alameda, CA – April 3, 2017 – Singulex, a global immunodiagnostics company pioneering ultra-sensitivity in the precision measurement of biomarkers, today announced they have CE marking for the Sgx Clarity® system, a fully-automated, in vitro diagnostics (IVD) platform, powered by Single Molecule Counting technology. Up to 1,000 times more sensitive than existing technologies, Single Molecule Counting technology measures biomarkers at the lowest levels, revealing what could not be seen before: the presence — or absence — of disease, so clinicians can provide the right treatment at the right time, resulting in better outcomes and cost savings.

    “Leading cardiologists, laboratorians, and health providers know that Singulex’s Single Molecule Counting technology has advanced our knowledge of cardiac troponin and its ability to effectively understand heart health and status,” said Dr. Paul Collinson, Professor of Cardiovascular Biomarkers at St. George’s University of London. “By applying the power and sensitivity into an easy-to-use IVD platform via the Sgx Clarity system, we can now put that technology to use and make better informed treatment decisions, improve care management, and help lower cost.”

    Single Molecule Counting technology has been reported on in more than 130 peer-reviewed publications. Further clinical evaluation at sites in Barcelona, London, and Manchester is confirming the sensitivity and utility of this IVD system, which is designed to seamlessly integrate into laboratory workflow.

    “This is a momentous day for Singulex. We are pleased to achieve CE mark and begin the sale of our Sgx Clarity system in Europe,” said Guido Baechler, president and chief executive officer of Singulex. “Our vision is to revolutionize immunodiagnostics to guide treatment decisions and improve healthcare systems across the globe. We continue to develop assays to detect and rule out highly preventable diseases, such as cardiac, infectious, and inflammatory diseases. Together with our extensive physician and laboratorian network in Europe, we are now active in driving access and adoption of the Sgx Clarity system across the continent.”

    Singulex plans to CE mark a cardiac troponin I (cTnI) assay in Europe and will submit data for regulatory clearance of the Sgx Clarity system in the United States, anticipating U.S. Food and Drug Administration clearance in 2018. With a long-term vision for innovation in the field of advanced immunodiagnostics, Singulex is also developing a point-of-care platform for its Single Molecule Counting technology and is exploring additional applications beyond the clinical setting.

    About Singulex, Inc.
    Singulex is the revolutionary immunodiagnostics company focused on delivering ultra-sensitive diagnostics and absolute certainty of BioRemarkable power to detect and rule out disease. Singulex’s proprietary Single Molecule Counting technology detects biomarkers of disease that were previously undetectable to give physicians and laboratorians unprecedented insight into health status and the ability to identify the presence — and absence — of disease.

    For more information, please visit www.singulex.com.

    Contact:
    Jessica McCarthy. Vice President, Global Marketing & Communications
    Singulex, Inc. 

    Tel: +1 (510) 995-3855
    J.McCarthy@singulex.com

  • Alameda, CA – April 17, 2017 – Singulex, Inc., the creator of Single Molecule Counting immunodiagnostic technology, announced the closing of a $50 million senior-secured debt facility with Perceptive Advisors. The capital secured will fuel the continued growth of Singulex and its industry-changing Single Molecule Counting platform, which delivers unprecedented ultra-sensitivity and utility to some of the most prevalent and costly diseases.

    “Entering into this $50 million debt facility with one of the leading life sciences-focused investment partners is another important validation of our proprietary technology platform and our vision to redefine what is possible in immunodiagnostics,” said Guido Baechler, president and chief executive officer, Singulex. “The investment will help fuel our continued growth and innovation pipeline, including greater access of our Single Molecule Counting technology via our Sgx Clarity® system and point of care platform.”

    Singulex’s Single Molecule Counting technology provides immunodiagnostic assays that are up to 1,000 times more sensitive than those on other testing platforms, enabling unprecedented confidence in medical decisions. This proprietary technology powers next generation immunodiagnostics delivered through the Sgx Clarity system, a fully-automated in vitro diagnostics platform that will bring the power and benefits of Single Molecule Counting to hospitals and reference labs worldwide. The system is currently undergoing market evaluation in Europe and the United States and is not yet available for sale.

    “Perceptive Advisors is pleased to partner with Singulex in their journey to advance understanding and enable immediate action to identify and treat a range of disease,” Sam Chawla, Portfolio Manager at Perceptive Advisors. “The Company has a proven record of results and partnerships with leading health and life science innovators. We look forward to sharing in future growth and success.”

    Cantor Fitzgerald & Co. acted as exclusive financial advisor and sole placement agent to Singulex in this transaction.

    About Singulex, Inc.
    Singulex is the revolutionary immunodiagnostics company focused on delivering ultra-sensitive diagnostics and absolute certainty to deliver the BioRemarkable power to rule out disease. Singulex’s proprietary Single Molecule Counting technology detects biomarkers of disease that were previously undetectable to give physicians and scientists unprecedented insight into health status and the ability to identify the presence—and absence—of disease. For more information, please visit www.singulex.com.

    About Perceptive Advisors
    Founded in 1999 and based in New York, NY, Perceptive Advisors is an investment management firm focused on supporting the progress of the life sciences industry by identifying opportunities and directing financial resources to the most promising technologies in healthcare. For more information about Perceptive, visit www.perceptivelife.com.

    About Cantor Fitzgerald & Co.
    Cantor Fitzgerald & Co., a leading global financial services group at the forefront of financial and technological innovation has been a proven and resilient leader for over 65 years. Cantor Fitzgerald & Co. is a preeminent investment bank serving more than 7,000 institutional clients around the world, recognized for its strengths in fixed income and equity capital markets, investment banking, prime brokerage, and commercial real estate finance and for its global distribution platform. Cantor Fitzgerald & Co. is one of 23 primary dealers authorized to trade U.S. government securities with The Federal Reserve Bank of New York. For more information please visit www.cantor.com.

    Contact:
    Jessica McCarthy. Vice President, Global Marketing & Communications
    Singulex, Inc. 

    Tel: +1 (510) 995-3855
    J.McCarthy@singulex.com
  • ALAMEDA, CA – June 1, 2017 – Singulex, a global immunodiagnostics company pioneering ultra-sensitivity in the precision measurement of protein biomarkers, today announced it has applied the CE Mark to its ultra-sensitive troponin I assay (cTnl), the first offered on the Sgx Clarity® system, a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology.

    The Singulex Sgx Clarity cTnl Assay quantitatively measures the biomarker troponin at levels far lower than existing technologies. The Sgx Clarity cTnl Assay is indicated to be used in conjunction with clinical evaluation for ruling out cardiac ischemia in patients suspected of having coronary artery disease (CAD). Efficient rule-out helps avoid the costs and adverse effects of additional expensive and potential unnecessary testing, such as stress tests, and allows clinicians to focus resources on the sickest patients.

    “This is a tremendously attractive concept, especially, from an urgent care perspective,” said Alessandro Sionis, MD, Director of the Acute and Intensive Cardiac Care Unit, Hospital de la Santa Creu i Sant Pau, Universitat de Barcelona. “The increased sensitivity and analytical precision of this troponin I assay has the potential to greatly improve the safety and efficiency of myocardial ischemia rule-out in patients especially those presenting to the Emergency Department with chest pain.”

    Up to 100 times more sensitive than existing technologies, Single Molecule Counting-based diagnostics are the first ultra-sensitive tests to routinely and effectively identify minute quantities of protein biomarkers, giving clinicians greater insight, confidence, and certainty in disease detection, rule-out and patient management.

    “This is a significant milestone for Singulex as well as for laboratorians, clinicians, and patients,” said Guido Baechler, president and chief executive officer of Singulex. “We are working closely with European clinical research sites to develop best practices and training for optimal introduction and utility of our Sgx cTnl test for cardiac ischemia rule-out in patients suspected of having coronary artery disease.”

    The Singulex proprietary Single Molecule Counting technology has been validated in clinical studies involving more than 130,000 subjects, resulting in over 130 peer-reviewed publications. The company will submit data for regulatory clearance of the Sgx Clarity system and the Sgx Clarity cTnI Assay in the United States later this year, anticipating U.S. Food and Drug Administration clearance in 2018.

    About Coronary Artery Disease
    Coronary artery disease is the leading cause of death worldwide. A significant proportion of ambulatory health care visits are for evaluation of patients with suspected CAD, with an estimated 1.5 percent of the population presenting with chest pain every year. An estimated $108.9 billion are spent annually on CAD treatment. Optimizing the process for assessing patients presents an opportunity to improve patient outcomes and direct health resources to where they are most needed. 1

    About Singulex, Inc.
    Singulex is an immunodiagnostics company at the forefront of Single Molecule Counting technology, a new immunoassay technology recognized for unprecedented ultra-sensitivity in the precision measurement of biomarkers. Singulex is the developer of the Sgx Clarity System, a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology. With up to 1,000 times more sensitivity than existing technologies, Single Molecule Counting reveals the presence or absence of disease more clearly and definitively than was possible before. Assays to detect and rule out cardiac, infectious, and inflammatory diseases are in development. Singulex is also developing a point of care platform and exploring applications beyond the clinical setting.

    For more information, please visit www.singulex.com.

    Contact:
    Jessica McCarthy. Vice President, Global Marketing & Communications
    Singulex, Inc. 

    Tel: +1 (510) 995-3855
    J.McCarthy@singulex.com

    REFERENCE
    Skelly AC, Hashimoto R, Buckley DI, et al., Noninvasive Testing for Coronary Artery Disease Comparative Effectiveness Reviews, No. 171.Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 Mar., https://www.ncbi.nlm.nih.gov/books/NBK361155/ Accessed May 8, 2017

  • NEW ORLEANS, June 5, 2017  — Findings presented at the American Society for Microbiology’s ASM Microbe conference show that the ultra-sensitive Clostridium difficile toxin A/B assay in development for use on the Sgx Clarity™ system offers excellent sensitivity and may be a critical tool for improving the diagnosis of this life-threatening infection. The Sgx Clarity system is a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology.

    The Sgx Clarity system is CE marked and currently available in the European market.

    In initial pilot studies, the Sgx Clarity C. difficile assay demonstrated the ability to detect the disease-causing toxins at concentrations up to 100 times lower than commercially available immunoassay methods. The turnaround time for the Sgx Clarity C. difficile toxin A/B assay was shown to be less than one hour, allowing for rapid detection and rule-out of suspected C. difficile infections (CDI).

    “Having an ultra-sensitive C difficile toxin immunoassay would be a game changer,” said Christopher Polage, Associate Professor of Pathology and Infectious Diseases, University of California, Davis School of Medicine. “Our experience shows the importance of toxin testing to identify patients with C difficile infection and minimize over-diagnosis but there’s still a lot of anxiety in the field. Labs worry about missing individual CDI cases but hospitals are facing huge financial pressures to reduce CDI and blaming labs for using tests that don’t distinguish between infected and colonized patients. Having an ultra-sensitive toxin test would allow labs to give physicians a toxin result to help maximize the accuracy of CDI diagnosis without the worry of missing cases. This would improve patient care and allow hospitals to reduce CDI rates and avoid financial penalties, representing a ‘win-win’ for everyone.”

    The Single Molecule Counting-based C. difficile toxin A and B assay aims to be the first ultra-sensitive test to offer physicians and laboratorians the specificity intrinsic to toxin tests but at a sensitivity level that rivals molecular methods. The clinical goal is to help clinicians safely to rule out C. difficile infection with greater confidence and provide clinically actionable toxin detection in under an hour.

    “What makes our assays so promising is the degree of sensitivity and high precision we are able to offer with our Single Molecule Counting technology,” said Dr. Jeff Bishop, Sr. Vice President of Research and Development, who is leading C. difficile assay development at Singulex. “We continue to gain important insights into its use in infectious disease through our work with key opinion leaders in the US and in Europe and are looking forward to the next stage of development.”

    The Singulex proprietary Single Molecule Counting technology has been validated in clinical studies involving more than 130,000 subjects, resulting in over 130 peer-reviewed publications. The company will submit data this year for regulatory clearance of the Sgx Clarity system in the United States, anticipating U.S. Food and Drug Administration clearance in 2018.

    About Clostridium difficile infection
    C. difficile infection is the leading cause of gastroenteritis-associated death and has become the most common cause of health care–associated infections in U.S. hospitals. The excess health care costs related to C. difficile infection are estimated to be as much as $4.8 billion for acute care facilities alone. According to a study funded by the Centers for Disease Control and Prevention, C. difficile was responsible for almost half a million infections and was associated with approximately 29,000 deaths in 2011.

    C. difficile is a bacterium found in the air, water, soil, and in the feces of humans and animals. The bacteria are often spread in hospitals and nursing homes. Older adults in healthcare facilities are at most risk, though an increasing number of younger adults also develop C. difficile infections characterized by diarrhea more than 3 times a day, severe cramping, fever, nausea and dehydration.

    About Singulex, Inc.
    Singulex is an immunodiagnostics company at the forefront of Single Molecule Counting technology, new immunoassay technology recognized for unprecedented ultra-sensitivity in the precision measurement of biomarkers. Singulex is the developer of the Sgx Clarity System, a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology. With up to 1,000 times more sensitivity than existing technologies, Single Molecule Counting reveals the presence or absence of disease more clearly and definitively than possible before. Assays to detect and rule out cardiac, infectious and inflammatory disease are in development. Singulex is also exploring a point of care platform and applications beyond the clinical setting.
    For more information, please visit www.singulex.com.

    Contact:
    Jessica McCarthy. Vice President, Global Marketing & Communications
    Singulex, Inc. 

    Tel: +1 (510) 995-3855
    J.McCarthy@singulex.com

    REFERENCE
    Lessa F, Mu Y, Bamberg W, et al, Burden of Clostridium difficile Infection in the United States: N Engl J Med 2015;372:825-34. http://www.nejm.org/doi/pdf/10.1056/NEJMoa1408913 Accessed May 25, 2017


 Additional Info

Countries of Interest:
Austria, Belgium, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom, United States