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FDA approves Diazyme’s Vitamin B assays for use with clinical chemistry analyzers

Diazyme Laboratories has received 510(k) clearance from the US Food and Drug Administration (FDA) for Vitamin B12 and Folate assays for use with clinical chemistry analyzers.

Vitamin B12 and Folate will help to make normal red blood cells (RBCs), repair tissues and cells, synthesize DNA and keep the nervous system healthy.

The detection of B12 and Folate levels in blood samples will enable to diagnose the causes of anemia or neuropathy, evaluate nutritional status in patients and monitor the effectiveness of treatment for the deficiency of vitamins.

The company developed homogenous assays for Vitamin B12 and Folate that can be used with general clinical chemistry analyzers.

According to the company, the clinical chemistry analyzers are commonly available in all sizes of clinical laboratories.

Diazyme Laboratories managing director Dr Chong Yuan said: . "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.”

Diazyme Laboratories, which is a division of General Atomics, deploys its enzyme and antibody platform technologies to develop novel assays for clinical and research uses.

The company provides diagnostic blood tests for cardiac markers, diabetes, nutritional assessment, liver disease, renal disease and electrolytes.