FDA Grants Diazyme 510(k) Clearance to Market Its Direct HbA1c (Enzymatic, On-Board Lysis) Assay for Clinical Chemistry Analyzers

SAN DIEGO, CA – 28 November 2016 – Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its Direct HbA1c assay (Enzymatic, On-Board Lysis).  HbA1c refers to glycated hemoglobin which occurs when hemoglobin, a protein within red blood cells that transports oxygen through the body, joins with glucose in the blood, thereby becoming glycated. Measuring HbA1c allows clinicians to get an overall picture of what a patients average blood sugar levels have been over a period of months.  This measurement is the gold standard in allowing clinicians to track patients with diabetes.

In line with current clinical needs, Diazyme has developed a new enzymatic Direct HbA1c assay that is made of two liquid stable reagents (R1 and R2), and requires no offline sample preparation steps (using whole blood and on-board lysing) as well as no separate measurement of total hemoglobin (Direct HbA1c assay). Diazyme's new enzymatic Direct HbA1c assay is the most convenient and accurate HbA1c assay method available for use on general clinical chemistry analyzers. The assay method is NGSP certified. "Diazyme is excited to have developed a two liquid stable reagent enzymatic HbA1c assay with on-board lysis availability. By removing the extra steps of having to lyse the whole blood sample offline and having to measure the total hemoglobin separately, Diazyme is making HbA1c testing much simpler, more user friendly and more readily available to clinical labs of all sizes. Furthermore, Diazyme's new HbA1c assay dramatically improves laboratory workflow." said Dr. Chong Yuan, Managing Director of Diazyme Laboratories.

Diazyme Laboratories is headquartered in Poway, California. Diazyme uses its enzyme and antibody platform technologies to develop innovative assays for clinical and research uses with reduced costs and improved performance. Products include diagnostic blood tests for cardiac markers, diabetes, nutritional assessment, liver disease, renal disease and electrolytes. Information regarding Diazyme's enzyme technology and related products can be found on its website at www.diazyme.com.

For Further Information Contact:

Dr. Abhijit Datta, Ph.D

Douglas Borses

Public Relations
Craig Siljord