Diagnostic for Heart Attack and Stroke Risk Launched

A cardiovascular disease (CVD) risk assay will enhance cardiologists' ability to assess heart attack and stroke risk.

The laboratory-developed assay is based on gamma prime fibrinogen, a naturally occurring clotting protein in human blood. This biomarker is strongly associated with cardiovascular disease.

Developed by Gamma Therapeutics (Portland, OR, USA), the CVD assay will be marketed exclusively by Health Diagnostic Laboratory Inc. (HDL; Albuquerque, NM, USA), which also will lead the BETA testing of the assay for the US Food and Drug Administration (FDA; Silver Springs, MD, USA) approval.

Despite current diagnostic tests to assess heart disease or stroke risk, millions die each year from fatal heart attacks--500,000 in the US alone in 2009--many of which were preventable with more predictive testing methods. Launch of the partnership between HDL, Inc. and Gamma Therapeutics represents a combined effort to advance the preventative model for chronic disease management, based on the recent shift in the way physicians test for life-threatening conditions.

"The results are simple,” said Tonya Mallory, CEO and cofounder of HDL, Inc. "Thanks to advanced testing, it [is] now possible to reveal risk factors and biomarkers for cardiovascular and related diseases. The partnership with Gamma Therapeutics demonstrates HDL, Inc.'s ongoing goal to provide best of breed biomarkers, such as this new assay.”

Related Links:
Gamma Therapeutics
Health Diagnostic Laboratory Inc.
US Food and Drug Administration