Zora Expands CERT - A Validated Test for Cardiovascular and Diabetes Risk Prediction

Zora Biosciences Oy has announced the expansion of its Coronary Event Risk Test (CERT) to include prediction of type II diabetes. CERT is already commercialised as a Laboratory Developed Test (LDT) and partnered with the Mayo Clinic in the USA while in Europe it is directly available through Zora. CERT is based on bloodbased detection of a range of ceramides. The expanded version will be available in the first half of 2018.

Plasma ceramides are the new generation of predictors for adverse cardiovascular events resulting from unstable atherosclerotic plaque. Ceramides are complex lipids that play a central role in cell membrane integrity, cellular stress response, inflammatory signalling, and apoptosis. Ceramide levels have the potential to replace LDL-cholesterol levels as a reliable predictor of heart disease. LDL-cholesterol is not an ideal risk predictor for coronary artery disease (CAD) patients: almost 50% of hospitalized CAD patients have normal LDL-cholesterol levels.

Four specific ceramides have been identified by Zora as highly linked to cardiovascular disease and insulin resistance e.g. diabetes. These complex ceramide molecules can be quickly and accurately detected using Liquid Chromatography Mass Spectrometry (LCMS) and proprietary bioinformatics developed by Zora. The test allows for the first time reliable risk stratification for cardiovascular disease and diabetes in a single test. This exciting development enables a variety of interventional procedures to prevent development of both diseases.

Plasma ceramide levels can predict adverse cardiovascular events including myocardial infarction, and cardiovascular mortality within 1- 15 years. The CERT test from Zora enables stratification into low, medium, increased and high risk groups more accurately than the currently used lipid tests.

CERT has been fully validated in more than 27,000 patient samples analysed retrospectively and shown to be a much more reliable predictor of cardiovascular risk than other markers like LDL-C in use today. Recent work in 8000 primary and 4000 secondary patients has also shown that the test can reliably predict type II diabetes years before disease onset.

In 2016, Zora’s ceramide assay for prediction of cardiovascular risk was licensed to Mayo Medical Laboratories, part of Mayo Clinic, who offer it as part of their clinical test portfolio.

Zora is now seeking a global strategic partner for resources including investment and commercialisation to achieve global rollout. Zora is working with The Sage Group to identify a global partner with whom it will roll out its CERT test globally.

Reini Hurme, Zora's Founder and CEO, stated, “We are delighted to announce the development and forthcoming launch of this groundbreaking new assay combining prediction of cardiovascular disease risk and diabetes in a single test. This capability should transform patient treatment and disease management with huge economic benefits for healthcare systems worldwide. Our main objective now is to identify one or more global partners with whom Zora can work to roll out availability of this revolutionary test as widely as possible.”