FDA Approves 5 Biopool Blood Testing Kits

Biopool International Inc. recently received approval from the Food and Drug Administration to market five new blood testing systems it has developed.

The clinical test kits are commonly used to diagnose dysfunctions of the kidney, heart, brain, skeletal muscle and liver as well to detect tissue damage, atherosclerosis and coronary heart disease.

The FDA is expected to approve two other related Biopool test kits later this month, according to Michael D. Bick, chairman and chief executive. He said the company plans to develop 15 additional kits during the next year.

In addition to these test kits, which represent a new branch of Biopool technology, the Ventura company also develops, manufactures and markets kits used in the diagnosis of bleeding disorders and in the detection of drug abuse.

The approved kits supply a chemical that reacts with a patient’s blood to test enzyme levels, glucose levels, uric acid content and other indicators of a patient’s health.

“The FDA approval signals an expansion of our entire product range,” Bick said. “They are not brand-new technologies, but they represent huge markets and we want to participate in them. The in-vitro diagnostic market is $12 billion worldwide, and chemistry reagents represent $2 billion of that. We would like to achieve even 1% to 2% of the market share.”

Bick expects his company’s five approved test kits, and the two awaiting approval, to be available for sale by the end of the year.

Biopool reported net income of $437,362 on sales of $3,318,238 for the first six months of 1995, compared to a net income of $389,827 on sales of $2,694,739 for the same period in 1994. The company has 35 distributors worldwide who market the test kits to clinical and hospital laboratories and to physicians’ offices.