Biopool Wins FDA Approval for Blood-Clot Test

Biopool International of Ventura has received Food and Drug Administration approval to market a blood-clot detection kit.

Based on the approval, the company plans to market its new TintElize PAI-1 Assay Kit, which measures the level of plasminogen activator inhibitor-1 (PAI-1) in blood.

PAI-1 is a naturally occurring protein in the blood and is one of the most important proteins regulating fibrinolysis, or the body’s ability to break down blood clots.

Clinical studies have demonstrated that defective fibrinolysis is closely associated with coronary heart disease. Biopool officials said results of independent clinical studies have suggested that elevated levels of PAI-1 may be a stronger indicator of cardiovascular disease than total cholesterol.

Biopool’s first PAI-1 test kit was introduced in 1992.

Michael D. Bick, Biopool chairman and chief executive officer, said the new kit is an improvement over the original one “because it measures all forms of the protein molecule and is, therefore, more clinically significant.”

“The test is also more user-friendly, can be performed more rapidly and is easily automated,” Bick said.

FDA approval means insurance carriers are now more likely to reimburse test costs.

Biopool develops medical test kits to diagnose a wide range of bleeding disorders and assess cardiovascular risk factors as well as specialty chemistry controls used to monitor the presence of drugs.