FDA Grants Diazyme 510(k) Clearance to Market Its Vitamin B Assays for Clinical Chemistry Analyzers

SAN DIEGO, CA – (Nov 21, 2016) – Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearances to market its two B vitamin assays, Vitamin B12 and Folate assays. Vitamin B12 and Folate perform several important functions in the body. They are required to make normal red blood cells (RBCs), repair tissues and cells, synthesize DNA and keep the nervous system healthy. A deficiency in either of these two vitamins can cause megaloblastic anemia which presents with a wide range of disease symptoms. Furthermore, lack of Vitamin B12 can lead to long-term damage to the brain and nervous system, and lack of folate in pregnant women increases the risk of neural tube defects of newborn children. Testing Vitamin B12 and Folate levels in blood samples can help diagnose the causes of anemia or neuropathy; assess nutritional status in patients; and monitor the effectiveness of treatment for vitamin B12 or folate deficiency.

In line with current clinical needs, Diazyme developed homogenous assays for both Vitamin B12 and Folate, and the assays can be used with general clinical chemistry analyzers which are commonly available in all sizes of clinical laboratories. "The additions of B12 and Folate assays to Diazyme's existing homogenous Vitamin D assay provides clinical laboratories with the ability to run an important vitamin panel on their clinical chemistry analyzers". "This will dramatically improve the laboratory workflow, and make all three vitamin tests more cost effective, more user friendly, and more available to clinical labs of all sizes" 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

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Craig Siljord