Singulex, Inc., the developer of single molecule counting technology for use in both medical practice diagnostics and scientific research, has received from the United States Patent and Trademark Office (USPTO) a key patent (US9182405) for use of the biomarkers troponin I and T to determine cardiovascular health in humans using technological methods that count individual molecules.
The new patent complements five previous cardiac troponin patents granted to Singulex by the USPTO and European Patent Office that include claims for determining cardiovascular health status in humans via high-sensitivity assays.
“This US patent builds on previous acknowledgements of Singulex’s significant scientific discoveries about the use of troponin as a biomarker of human cardiovascular health, a primary focus of our proprietary single molecule counting technology. The continued growth of Singulex’s intellectual property enables us to offer physicians more precision in determining their patients’ heart health, even for those who have not had apparent heart attacks, and increased confidence in the proactive management of their patients’ health,” said Guido Baechler, President and Chief Executive Officer of Singulex.
Singulex was the first to discover that very low levels of the proteins troponin I or troponin T are detectable in the blood of healthy patients, using the company’s high-sensitivity single molecule counting technology. This technology allows precise, confident measurement of minute quantities of biomarker molecules. The company has demonstrated in numerous peer-reviewed publications that measuring such low biomarker levels is clinically meaningful, helps determine patients’ heart health status and aids physicians in managing their risk for future cardiovascular-related disease or death.
When heart muscle is significantly damaged, such as during a heart attack, large amounts of troponin leak into the blood stream. Existing troponin-based blood tests are used routinely in clinical practice to determine if patients have suffered a heart attack, but these assays are not able to measure low troponin levels in patients with minor heart muscle damage. Singulex’s patent portfolio covers high-sensitivity assays that measure these low troponin levels using any method, including those that digitize and count single molecules.
Singulex intends to include cardiac health diagnostics that measure both low- and high-levels of troponin in its European launch of the Sgx Clarity System, a high sensitivity immunoassay diagnostic platform, planned for 2016. Through pioneering research and development, Singulex has steadily added new knowledge about the significance of using troponin to gauge cardiovascular health, and received the patents EP2002260, EP2386858, US7838250, US8343728 and US8535895, since 2010.
The estimated global market for in vitro diagnostic tests for cardiac biomarkers was nearly $4 billion in 2013, with an anticipated growth to $7.2 billion by 2018. The World Health Organization estimates that cardiovascular diseases, including those of the blood vessels supplying the heart muscle and the brain, are the leading cause of death globally, killing about 17.5 million people in 2012, including an estimated 7.4 million owing to coronary heart disease. For more information about peer-reviewed scientific journal articles and presentations, visit http://www.singulex.com/scientific-journals-publications.