Press Release: Zora Announces CERT – A Validated Test for Cardiovascular and Diabetes Risk Prediction

Espoo, Finland, 3 January 2018 – Zora Biosciences Oy (“Zora”) announces 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 blood-based 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 Mayu 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.”

About Zora Biosciences

Zora Biosciences Oy (“Zora”) is a translational discovery firm involved in developing biomarker-based diagnostics tests. Zora is seeking a partner or partners with whom to collaborate to bring its first commercial product, CERT, for the assessment of cardiovascular risk and predilection to type II diabetes, to market. Zora also has an exciting development program in detection of ovarian cancer (OCDT).

Zora provides an opportunity to gain potential market leadership with CERT, a new paradigm for prediction of cardiovascular risk and diabetes with a single test using patented biomarkers. This test has been validated in many thousands of patient samples using retrospective cohorts. These were analyzed using unique high throughput test protocols using LCMS and bioinformatics, and Zora has numerous granted and pending patents with long life and strong Freedom to Operate in the cardiovascular domain. Zora has also developed strong clinical associations and access to large patient cohorts.

Zora is working with The Sage Group to identify one or more global partners for its CERT and OCDT tests,

About Cardiocascular Heart Disease

  • Cardiovascular heart disease (CHD) is a global health issue. WHO ranks CHD as the Number 1 killer globally.
  • An estimated 17.7 million people died from this disease in 2015, representing 31% of all global deaths. Of these deaths, an estimated 7.4 million were due to coronary heart disease and 6.7 million were due to stroke.
  • In 2015, more than 110 million people globally were thought to suffer from cardiovascular disease.
  • Most people will be able to reduce their risk by relevant changes in lifestyle, optimizing treatment of relevant comorbidities, and by drug treatment, if appropriate.
  • Lifestyle measures that can reduce CVD risk include:
    • Smoking cessation
    • Weight loss if overweight or obese
    • Eating a healthy diet
    • Keeping alcohol consumption within the recommended limits
    • Being physically active
  • Statin treatment should be offered for the primary prevention of CVD to people with an estimated 10 year CVD risk of 10% or more if lifestyle interventions have not proved effective.

For more information about Zora Biosciences and partnering opportunities for its CERT and OCDT tests, contact:

Dr. Reini Hurme
CEO, Zora Biosciences Oy
Espoo, Finland