Singulex announces 510(k) submission for the first ultra-sensitive cardiac troponin I (cTnI) test using Single Molecule Counting technology

ALAMEDA, Calif., Nov. 1, 2017 /PRNewswire/ -- Singulex, a global immunodiagnostics company pioneering ultra-sensitivity in the precision measurement of biomarkers, today announced it has filed a 510(k) pre-market notification submission with the U.S. Food and Drug Administration for its Singulex Clarity^® cTnI assay to run on the Singulex Clarity system, a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology. 

The Singulex Clarity cTnl assay is the first test to quantitatively measure cardiac troponin at levels far lower than existing technologies. The indication submitted for review is for use in conjunction with clinical evaluation as an aid in the diagnosis of myocardial infarction.

"Submitting our cTnI assay to the FDA is a significant milestone for Singulex. This brings us another step closer to providing laboratorians, clinicians and patients in the U.S. with unprecedented precision and sensitivity in the measurement of a proven cardiac biomarker that can have significant positive impact on patient health," said Guido Baechler, President and Chief Executive Officer of Singulex. "Key opinion leaders in Europe who have been working with our cTnI assay on the Clarity system have been very pleased with its performance. Several have generated data demonstrating the clinical value of measuring low concentrations of troponin in the chronic ambulatory patient setting as part of our Clinical Research program."

Earlier this year, Singulex CE marked the Singulex Clarity system and the Singulex Clarity cTnl assay, indicated to be used in conjunction with clinical evaluation for ruling out cardiac ischemia in patients suspected of having coronary artery disease (CAD) clearing the path for the commercialization of the assay and instrument in the EU.

Up to 1,000 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 biomarker molecules, giving clinicians greater insight, confidence and certainty in earlier detection, rule-out and management of disease.

The Singulex proprietary Single Molecule Counting technology has been validated in clinical studies involving more than 130,000 subjects, resulting in over 150 peer-reviewed publications.

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.

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 Singulex 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.

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

SOURCE Singulex