Poway, CA, United States
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SAN DIEGO, CA--(Marketwired - November 30, 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 patient's 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 a division of General Atomics headquartered in La Jolla, 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.


SAN DIEGO, CA--(Marketwired - November 22, 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 a division of General Atomics headquartered in La Jolla, 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.


Saida F.B.,Diazyme Laboratories | Chen X.,Diazyme Laboratories | Tran K.,Diazyme Laboratories | Dou C.,Diazyme Laboratories | Yuan C.,Diazyme Laboratories
Expert Review of Molecular Diagnostics | Year: 2015

25-Hydroxyvitamin D [25(OH)D], the predominant circulating form of vitamin D, is an accurate indicator of the general vitamin D status of an individual. Because vitamin D deficiencies have been linked to several pathologies (including osteoporosis and rickets), accurate monitoring of 25(OH)D levels is becoming increasingly important in clinical settings. Current 25(OH)D assays are either chromatographic or immunoassay-based assays. These assays include HPLC, liquid chromatography-tandem mass spectrometry (LC-MS/MS), enzyme-immunosorbent, immunochemiluminescence, immunofluorescence and radioimmunoassay. All these assays use heterogeneous formats that require phase separation and special instrumentations. In this article, we present an overview of these assays and introduce the first homogeneous assay of 25(OH)D for use on general chemistry analyzers. A special emphasis is put on the unique challenges posed by the 25(OH)D analyte. These challenges include a low detection limit, the dissociation of the analyte from its serum transporter and the inactivation of various binding proteins without phase separation steps. © 2015 Informa UK, Ltd.


Abidin D.,Diazyme Laboratories | Liu L.,Diazyme Laboratories | Dou C.,Diazyme Laboratories | Datta A.,Diazyme Laboratories | Yuan C.,Diazyme Laboratories
Analytical Methods | Year: 2013

Recent studies have shown that blood HbA1c levels alone may not accurately reflect serum glucose concentrations in all diabetic patients. For certain diabetic patients, there exists a glycation gap. It was reported that the glycation gap information obtained by measuring HbA1c and glycated serum protein (GSP) or glycated albumin (GA) together may improve evaluation of diabetic patients by more reliably predicting complications of diabetes than HbA1c alone. Therefore, a new GSP assay for clinical use was developed and its performance was evaluated. Diazyme's enzymatic GSP assay (trademarked GlycoGap®) is formulated with a 2-part liquid stable reagent system with a shelf-life of >15 months when stored at 2-8 °C. The assay was highly reproducible with within-run and total imprecisions of ≤1.3% CV. Method comparison studies showed good correlations with a previous powder version GSP assay (r2 = 0.9966) and with Lucica® GA-L assay (r2 = 0.9746). The assay was linear within the range of 21-1354 μmol L-1 with a reference range of 151-300 μmol L-1 and was not affected by substances commonly found in human specimens such as ascorbic acid, bilirubin, hemoglobin, glucose, triglycerides, or uric acid. Diazyme's GSP assay was highly accurate with no interferences from endogenous reducing substances which interfere strongly with the traditional NBT based fructosamine assay. A conversion equation was developed to allow conversions of GSP values (μmol L -1) into % of GA values, and a reference range for %GA was established for the US population. The relationship between %GA and %HbA1c was also investigated by measuring both %GA and %HbA1c values of blood samples from both diabetic and non-diabetic donors. This journal is © 2013 The Royal Society of Chemistry.


Rynearson K.D.,University of California at San Diego | Dutta S.,University of California at San Diego | Dutta S.,Indian Institute of Chemical Technology | Tran K.,University of California at San Diego | And 3 more authors.
European Journal of Organic Chemistry | Year: 2013

The streptolidine lactam is an amino acid constituent of streptothricin antibiotics, which inhibit protein synthesis by targeting the bacterial ribosome but suffer from toxicity as a result of the basicity of the aminoimidazole scaffold in the natural products. On the basis of the streptolidine structure, we designed and synthesized oxazole analogs with six- and seven-membered lactam rings as building blocks for RNA-targeted ligands. These analogs benefit from a dense network of hydrogen-bond donors and acceptors within a rigid nonplanar heterocyclic system that has attenuated basicity. Oxazole analogs based on the streptolidine scaffold of natural RNA-binding streptothricin antibiotics were designed and synthesized as building blocks for RNA-targeted ligands. These synthetic analogs with six- and seven-membered lactam rings benefit from a dense network of hydrogen-bond donors and acceptors within a rigid nonplanar heterocyclic system that has attenuated basicity. Copyright © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

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