Diazyme Receives FDA 510(k) Clearance for Enzymatic Total Bile Acids Assay Kit


Dec 22, 2005

SAN DIEGO, CA - Dec 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).

"We are very pleased to have received FDA 510(k) clearance of our Total Bile Acid assay", said Dr. Chong Yuan, Managing Director of Diazyme Laboratories. "We have successfully marketed this assay in the Asian market for the past several years. FDA 510(k) clearance will now allow us to offer this test to U.S. clinical laboratories."

Diazyme's Enzymatic Total Bile Acids Assay is an enzyme cycling based assay system using two liquid stable reagents (R1 and R2). The assay is more sensitive and has less interference from endogenous substances than the conventional enzyme colorimetric method (lyophilized powder format). The assay uses a smaller serum sample amount and reports results in less than 10 minutes. The assay has excellent accuracy and precision with a wide dynamic range (1-180 _mole/L). The assay is fully automated and can be used in any automated chemistry analyzer. More information about this test kit is available on Diazyme's web site at www.diazyme.com, or by contacting support@diazyme.com or (858)455-4768.


Steve O'Hara

Diazyme Laboratories

(858) 455-3911