SAN DIEGO, CA -- (MARKET WIRE) -- April 19, 2007 -- Diazyme Laboratories announced today that the
U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k)
clearance to market its Direct Enzymatic Hemoglobin A1c (HbA1c) Assay Kit
for the quantitative determination of HbA1c in human whole blood samples.
The company also announced today that it has successfully completed the
National Glycohemoglobin Standardization Program (NGSP;
www.ngsp.org)
manufacturer certification for this assay. The Diazyme Direct Enzymatic
HbA1c method is now traceable to the Diabetes Control and Complications
Trial (DCCT) reference method.
HbA1c is an important test recommended by the American Diabetic Association
(ADA) for monitoring patient glycemic status. HbA1c refers to glucose
modified hemoglobin A (HbA) specifically at N-terminal valine residues of
hemoglobin beta chains.
Diazyme's Direct Enzymatic HbA1c Assay has all the advantages of both the
HPLC and immunoassays methods in the areas of accuracy, specificity,
applicability to chemistry analyzers and is cost effective, simpler and has
no interference from hemoglobin variants. The HbA1c test uses two
ready-to-use liquid stable reagents. Since it does not require a separate
measurement of total hemoglobin content in the samples, the assay only
needs a single channel to perform the test on chemistry analyzers in
comparison with some immunoassays that require a separated measurement of
total hemoglobin and need two channels for the test on chemistry analyzers.
Diazyme's assay requires no post analytic calculations, and the results are
directly reported as % of HbA1c.
Key Assay Characteristics:
-- Two reagents, liquid stable
-- Single channel
-- No need for total hemoglobin measurement
-- No need for post analytic calculations
-- Cost effective
-- Applicable to most analyzers
-- Excellent correlation with HPLC and immunoassays
-- No interferences from hemoglobin variants
-- NGSP certified
Diazyme Laboratories is a division of General Atomics headquartered in La
Jolla, California. Diazyme uses its platform enzyme technologies including
enzyme cycling, Substrate-Trapping-Enzyme (STE), and Allosteric Enzyme
Coupled Immunoassay (AECIA), to develop low cost and uniform diagnostic
products for clinical and research use. Products include diagnostic blood
tests for liver disease, cardiac markers, diabetes and electrolytes.
Diazyme's enzyme technology and related products can be found in its
website at
www.diazyme.com
Contact Information: For Further Information Contact:
Diazyme Laboratories:
Chong Yuan
(858) 455-4760
Email Contact
Public Relations:
Doug Fouquet
(858) 455-2173
Email Contact