Diazyme Laboratories, Poway, Calif, which develops diagnostic products for clinical and research uses, says the FDA has granted 510(K) clearance for marketing its Enzymatic Total Bile Acids assay kit for the quantitative determination of the acids in human blood samples.
The assay is an enzyme cycling-based system using liquid stable reagents (R1 and R2) that uses a smaller serum-sample amount and yields results in less than 10 minutes with a wide dynamic range (1-180 _mole/L). It is fully automated and can be used in most automated chemistry analyzers.
Total bile acids are a biomarker for diagnosis of liver diseases. Their levels are found to be the most sensitive indicator for monitoring the effectiveness of interferon treatment of chronic hepatitis C patients. Serum total bile acids are elevated in patients with acute hepatitis, chronic hepatitis, liver sclerosis, and liver cancer.
For years the company has marketed the assay in the Asian market.
