SAN DIEGO, CA -- (MARKET WIRE) -- 12/22/2005 -- Diazyme Laboratories, a company that applies its proprietary enzyme technologies to develop low cost and high quality diagnostic products for clinical and research uses, announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(K) clearance to market its Enzymatic Total Bile Acids (TBA) Assay Kit for the quantitative determination of total bile acids in human blood samples. Total bile acids is a well known bio-marker for diagnosis of liver diseases. Serum total bile acids are elevated in patients with acute hepatitis, chronic hepatitis, liver sclerosis, and liver cancer. Total bile acids levels are found to be the most sensitive indicator for monitoring the effectiveness of interferon treatment of chronic hepatitis C patients. Moreover, total bile acids tests are also widely used to screen pregnant women for the condition of obstetric cholestasis, a disease that is caused by elevated total bile acids in the bloodstream of pregnant women. The symptoms of cholestasis include persistent itching in the third trimester of pregnancy and possible risks to the unborn baby including stillbirth, premature labor and bleeding. The frequency of obstetric cholestasis is found to be 1 in 100 pregnant European women, and 1 in 10 pregnant South American women. Cholestasis treatment includes the drug Urso® (Axcan Pharma
