Newly established biotech firm Gamma Therapeutics is partnering with Health Diagnostic Laboratory (HDL) to develop a novel cardiovascular disease (CVD) prognostic and predictive assay the firms hope will help cardiologists assess patients’ risk of heart attack and stroke. The assay is based on the human clotting protein gamma prime fibrinogen, which Gamma says is strongly linked with cardiovascular disease. The firm’s new partnership aims to develop a laboratory test version of the CVD assay, which HDL will take through beta testing. Once approved by FDA, the assay will also be offered exclusively by HDL.
Gamma claims that early studies, including those performed by the Framingham Heart Study and the Stockholm Coronary Artery Risk Factor Study, indicate that elevated blood levels of gamma prime and total fibrinogen within the upper 33rd percentile range can indicate a threefold increased risk of heart attack. Gamma prime fibrinogen levels in the upper 25th percentile point to a sevenfold increased risk of coronary artery disease, the firm adds.
Gamma is exploiting gamma prime fibrinogen to develop both prognostic assays and surgical tools. The firm’s flagship GammaCoeur™ CVD risk assay is designed to complement traditional testing methods such as total fibrinogen, cholesterol, triglyceride and glucose, for heart attack and stroke risk. The company says it hopes to have a prototype assay ready by mid- 2011 and begin beta testing later in the year.
Gammaseal™ is a developmental high-strength surgical sealant for use in areas of mechanical strain such as large artery vascular surgery or wound repair. Gammarin™ is a next-generation, non-immunogenic short-acting intravenous anticoagulant, designed as a peptide fragment of gamma prime fibrinogen, which is in development for use both before and after major surgery. Gamma Therapeutics is currently funded with a $1.46 million, three-year NIH SBIR grant to develop GammaCoeur.
HDL is a an accredited clinical laboratory offering a broad menu of biomarker, risk factor evaluation, and disease-state management tests in the field of cardiovascular disease and related disorders, including heart failure, stroke, diabetes mellitus, metabolic syndrome, and nonalcoholic steatohepatitis (fatty liver disease).