Haptoglobin Diagnostic Kit Determines Cardiovascular Risk in Diabetics

A monoclonal enzyme immunoassay determines a person's haptoglobin pheno/genotype in less than two hours, and can aid physicians in predicting cardiovascular risk in patients with diabetes.

Haptoglobin (Hp) is a common serum protein that binds free hemoglobin released from red blood cells. Extracellular hemoglobin (hemoglobin not found in red blood cells) is a potent oxidizing agent capable of inflicting oxidative tissue damage. Haptoglobin binds to this extracellular hemoglobin and inhibits hemoglobin-induced oxidation. Once hemoglobin is bound to haptoglobin, it is rapidly cleared from the bloodstream by the liver or by specialized white blood cells.

Haptoglobin in humans exists as three different proteins that arise from one of three haptoglobin gene combinations in the population, Hp 1-1 (16%), Hp2-2 (36%), and Hp1-2 (48%). For a variety of reasons, Hp2-2 is more effective than Hp1-1 at preventing hemoglobin-induced oxidation in the bloodstream and blood vessel wall.

Synvista Therapeutics Inc. (Montvale, NJ, USA) announced findings from a study in which investigators developed an enzyme-linked immunosorbent assay (ELISA) using a monoclonal antibody that differentiates between the three haptoglobin pheno/genotypes. Blood samples from diabetic patients with known haptoglobin pheno/genotypes were tested using Synvista's methodology. Results demonstrated 99.5% accuracy in determining each of the three haptoglobin types (48/48 Hp 1-1, 49/49 Hp2-1, and 90/91 Hp-2-2) with a greater than or equal to 98% sensitivity and specificity for each phenotype.

"This study shows the utility of our proprietary technology to diagnose Hp2-2 diabetes, a disease affecting almost seven million people in the United States,” said Noah Berkowitz, M.D., Ph.D., president and CEO of Synvista Therapeutics. "We believe that the ease of use of our haptoglobin diagnostic technology and rapid results bode well for its acceptance as an important tool in the treatment of cardiovascular disease in diabetic patients. In addition, we believe that the development of genetic markers like those identified by our test will continue to pave the way toward a personalized medicine model that will benefit a wider variety of patients in a more direct and reliably predictive manner.”

The study was presented at the Cardiovascular Biomarkers and Surrogate Endpoints Symposium in Bethesda (MD, USA) in September 2008.

Synvista Therapeutics is a biopharmaceutic company developing diagnostics and drugs to diagnose, treat, and prevent cardiovascular disease in people with diabetes. In addition to its clinical diagnostic test for Hp2-2 diabetes test, Synvista is developing a kit to measure carboxy-methyllysine (CML), another potential cardiovascular risk marker.

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