Corgenix completes clinical trial of AtherOx test kit

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Dec. 6 – Corgenix Medical, a developer of diagnostic test kits, has announced the results from a preliminary clinical trial involving its AtherOx test kit.

The in vitro diagnostic study took place at the cardiology department at Kurashiki Central Hospital in Okayama, Japan, and was conducted to measure levels of AtherOx in healthy individuals and patients with severe cardiovascular complications.

The Denver-based Corgenix said the initial study results indicate that the test may be used to identify patients at increased risk of major complications from heart disease such as heart attacks or severe chest pain.

The study involved patients with acute coronary syndrome (ACS) and a control group of healthy individuals. Corgenix said its AtherOx test found significantly higher serum levels of oxLDL/beta2GPI complexes in the ACS patients compared to healthy controls, and particularly in those patients with acute myocardial infarction and unstable angina.

“The measurement of oxLDL/beta2GPI complexes in patients with cardiovascular diseases provides a novel serologic marker for those patients prone or at risk for more severe complications such as heart attack or unstable chest pain,” said Katsumi Inoue, MD, director of the Clinical Research Center at the Kurashiki Central Hospital and principal investigator of the study. “We intend to continue our study and then publish all of the data in a major medical journal when completed.”  

Further trials to confirm the initial findings of the cardiovascular disease risk marker are scheduled in both the U.S. and Japan over the next several years, according to Corgenix.

Corgenix Medical and Biological Laboratories sponsored the study.