Biopool Gets FDA’s OK to Market Product

Biopool International in Ventura has received approval from the Food and Drug Administration to market a product to control screening for thrombotic disease.

Biopool’s new Lupus Anticoagulant Positive Control Plasma will be used in the quality-control monitoring of tests for the anticoagulant.

The presence of lupus anticoagulant is associated with numerous clinical conditions, including infectious and autoimmune diseases and certain cancers.

Individuals with lupus anticoagulant are at substantially increased risk for thromboembolic diseases such as blood clots. Pregnant women who are lupus anticoagulant-positive are at risk for spontaneous abortion.

Currently, there is no one specific test for this anticoagulant; rather, a series of screening and confirmatory tests are employed. Biopool’s Lupus Anticoagulant Positive Control can be used with all the commonly employed screening and confirmatory tests, company officials said.

Biopool develops and manufactures test kits to assess and diagnose disorders of blood coagulation, thrombotic risk factors, platelet function and the vascular system, as well as to measure the presence of illegal drugs.

The company’s products are sold to hospitals and laboratories.