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

SAN DIEGO, CA – 25 April 2017 – Diazyme Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its Procalcitonin (PCT) assay. Procalcitonin, a propeptide synthesized in the C-cells of the thyroid, has been identified to be more clinically useful and superior than currently used common clinical variables and laboratory tests in the diagnosis of sepsis. PCT is ubiquitously and uniformly expressed in multiple tissues throughout the body. In healthy conditions, PCT levels in circulation are very low. Rising PCT concentrations can be detected within 2 - 6 hours after infectious challenges and peak within 6 - 24 hours. Once an infection is under control, PCT levels decrease. This rapid response is highly specific to bacterial infections and has made PCT one of the most pertinent biomarker's used in detecting bacterial infection or sepsis.

In line with current clinical needs, Diazyme's homogenous immunoturbidimetric PCT assay can be utilized to measure PCT levels in both serum and plasma samples. The assay is both fast and flexible with complete test results in minutes. "Diazyme's PCT assay is making PCT testing much more user friendly, accessible and readily available to clinical and hospital labs of all sizes. Having the ability to run Diazyme's PCT test on many commonly used clinical chemistry analyzers allows users a new flexible and cost effective option that can be easily integrated into their current laboratory workflow "said Dr. Chong Yuan, Managing Director of Diazyme Laboratories, Inc.

Diazyme Laboratories, Inc. is headquartered in Poway, CA. Diazyme uses its enzyme and antibody platform technologies to develop innovative assays for clinical and research uses with improved performance and lowered costs. Diazyme products include tests for sepsis, cancer, cardiovascular disease, diabetes, nutritional assessment, liver disease, renal disease and electrolyte measurement. Information regarding Diazyme's platform technologies and products can be found on its website www.diazyme.com.

For Further Information Contact:

Dr. Abhijit Datta, Ph.D

Douglas Borses

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Craig Siljord