Diagnostic Monitoring Device
In 2010, the firm began processing customer blood samples through its advanced cardiovascular diagnostic monitoring service. Singulex analyzed more than 170,000 blood samples in its CAP-certified and CLIA-licensed California lab in 2012. To date the company has processed more than 3 million clinical tests, Baechler says, noting that additional diagnostic services are coming down the pike.
Because the technology can be used to detect low-abundance biomarkers in healthy populations, it improves the prognostic and diagnostic power of established biomarkers associated with increased risk for developing cardiovascular diseases, such as heart failure, notes Baechler. “Our technology can improve patient care while reducing healthcare costs,” he suggests.
Baechler points to case studies in which ostensibly healthy individuals, who presented with elevated cardiac troponin and inflammation biomarker levels, were subsequently referred to specialists who, with further monitoring, identified significant risk of a cardiac event.
“We see this quite frequently and that’s really a driver of what we’re doing today,” Baechler says.
“Combining cardiac troponin with cytokines and other inflammatory markers and pairing it with advanced lipid tests, we are able to provide a full panel to physicians to identify patients at risk in a chronic setting for a primary or secondary cardiac event so they can individualize treatment strategies and monitor the effectiveness of therapies over time.”
The company is now working to develop a next-generation, fully automated benchtop immunoassay analyzer that can run up to 15 different tests on a single sample with a turnaround time similar to that of standard platforms, around 20 to 30 minutes.
“This system will allow us to distribute our immunoassay technology globally to hospitals and reference labs,” Baechler says.
At the same time, he adds, the company’s digital immunoassay technology is “continuing to power discovery and development of innovative diagnostics and treatments for chronic diseases beyond cardiovascular disorders,” such as Alzheimer’s, arthritis, and diabetes.
“The ability to measure biomarker concentrations at healthy levels—not possible previously with other technologies—and to monitor small changes in concentrations over time has expanded the clinical utility of proven and emerging biomarkers, thus providing researchers with new insights into disease biology, drug safety, and efficacy,” Baechler says.