Biopool Wins Japan’s OK for Heart Disease Test Kit
Biopool International Inc. of Ventura has received Japanese government approval for the use of Biopool’s TintElize Lp(a) test kit for diagnosing heart disease risks.
The action opens the largest potential market thus far for the kit, which measures Lipoprotein(a), a form of blood cholesterol that is a major risk factor for coronary artery disease and other heart-related problems, said Michael D. Bick, Biopool’s chief executive officer.
The test kits have not been approved for use in the United States.
He said Japan’s Ministry of Health and Welfare studied the kit for three years before certifying it for use in hospitals, clinics and laboratories.
“It’s a major breakthrough for the product,†Bick said. He added that the Ventura company’s Japanese distributor, Cosmo Bio Co. of Tokyo, plans an extensive marketing campaign for the kit.
Bick said he hopes TintElize Lp(a) will someday be approved for U.S. use, “but many hurdles remain before the Food and Drug Administration process is completed.â€
Biopool produces test kits used worldwide in diagnosing heart and blood disorders.
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