Biopool Gets FDA OK to Market New Products

Biopool International has received FDA clearance to market two new products, company officials said.

The Ventura company may now begin marketing its test for determining sensitivity to activated protein C and its anti-D blood grouping reagent.

The company’s Bioclot APC Sensitivity Kit is used to screen for protein C resistance and identify individuals at risk of developing life-threatening thrombotic disease. The most common reason for the resistance is a genetic mutation in the blood-clotting gene. Thrombotic diseases affect nearly 25 million people annually in the United States and Europe.

The disorder leads to some 300,000 deaths in the United States each year, Biopool officials said. Other conditions that can lead to resistance to activated protein C include pregnancy, malignancy and oral contraceptive use.

The anti-D product is a combination of human antibodies and adapts to all common test procedures used in the blood bank laboratory, Biopool officials said. Anti-D testing is mandatory for all pre-transfusion blood donors and recipients. The terms “Rh positive” and “Rh negative” refer to the presence or absence of the D antigen.

Anti-D testing is performed in hospitals as well as at all blood donor centers.