FDA Grants Diazyme 510(k) Clearance to Market Its Fibrinogen Assay for Clinical Chemistry Analyzers

FDA Grants Diazyme 510(k) Clearance to Market Its Fibrinogen Assay for Clinical Chemistry Analyzers

SAN DIEGO, CA – (Feb 24, 2016) - Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its Fibrinogen Assay. Fibrinogen is a protein involved in the blood clotting (coagulation) process. Clinically, fibrinogen is used as a biomarker for detecting blood clotting and bleeding disorders. Fibrinogen is an acute-phase reactant. Its level in blood rises sharply during tissue inflammation or injury, and therefore, elevated fibrinogen levels in blood can be used as a predictor for an increased risk of heart or circulatory diseases.

In line with current clinical needs, Diazyme's Fibrinogen immunoturbidimetric assay can be utilized to measure fibrinogen in plasma samples. The assay is both fast and flexible with complete test results in minutes. Furthermore, the assay has been designed to work on most high throughput clinical chemistry analyzers, allowing users faster results and improved laboratory workflow.

"Diazyme's Fibrinogen assay provides a precise, flexible and cost effective test method for laboratories of virtually all sizes. Utilization of Diazyme's technology in this assay will lead to overall improved workflow for laboratories," said Dr. Chong Yuan, Managing Director of Diazyme Laboratories. "Diazyme's latex enhanced immunoturbidimetric Fibrinogen is highly precise with excellent correlation to existing commercial myoglobin assay methods."

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.

For Further Information Contact:

Regulatory
Dr. Abhijit Datta, Ph.D
Abhijit.Datta@diazyme.com

Sales
Douglas Borses
860-729-0121
Douglas.Borses@Diazyme.com

Public Relations
Doug Fouquet
(858) 455-2173
fouquet@ga.com