Zora Brings Molecular Lipids to the Clinic for Cardiovascular Risk Prediction with Enhanced Capacity
Zora’s laboratory has been able to improve its robotized mass spectrometry workflow such that one machine is able to analyze up to 12 000 samples per month. High volume performance is compliant with the required analytical quality specifications. In the past, a common concern regarding the feasibility of LC-MS/MS for the clinical environments and reference laboratory settings has been its throughput capacity. In a novel multiplexing set-up it is possible to align the sample preparation robotic output with short analysis time on the LC-MS/MS thus matching the analytical capacity of other clinical analyzer platforms.
CERT, the ceramide-based risk score test is available widely in Finland through private health care providers and select public sites, all samples being analyzed by the Zora reference facility in Espoo. Test expansion to other European nations is underway. CERT is also commercialized as a Laboratory Developed Test (LDT) in the USA, in which Zora collaborated with Mayo Clinic.
CERT is based on the mass spectrometric quantification of four blood-based ceramide lipid species. CERT is able to assess residual risk and estimate the risk of future myocardial infarctions or cardiac death. CERT enables patient stratification into risk groups more accurately than the currently used lipid tests. Plasma ceramides represent the next generation of clinical predictors for adverse cardiovascular events resulting from unstable atherosclerotic plaques. Ceramides are bioactive lipids that play a central role in cell membrane integrity, cellular stress response, inflammation, signaling, and apoptosis. CERT has the potential to replace LDL-cholesterol as a reliable predictor of cardiovascular events. LDL-cholesterol is not an ideal risk predictor for coronary artery disease (CAD) patients as almost 50% of hospitalized CAD patients have normal LDL-cholesterol levels.
CERT has been extensively validated in more than 80,000 patient samples analyzed retrospectively and shown to be a much more reliable predictor of cardiovascular risk than other markers in use today. Zora is also developing tests for ovarian cancer diagnostics as well as adding cardiometabolic capabilities in fatty liver disease and diabetes detection.
Reini Hurme, Zora’s Founder and CEO, stated, “We are delighted to announce the development of our laboratory capacity to unprecedented levels thereby demonstrating the power and capabilities of mass spectrometry for robust clinical diagnostic applications. Higher volume throughputs will be required as ceramide-based risk testing gains wider acceptance as the next generation cardiovascular disease prevention tool”