Wide-Rande C-Reactive Protein Assay

The test has been cleared by the U.S. Food and Drug Administration (FDA).

Because C-reactive protein is a blood component that increases rapidly in infections, tissue trauma, or other injuries to the body, its rapid rise and fall make it a very useful non-specific indicator of acute inflammation. CRP elevates within four to six hours after an infection or injury occurs. Levels may increase up to 1,000 times normal and peak in about 24-48 hours. Decreases in CRP occur very rapidly after trauma or infection resolves. Elevated CRP occurs in conditions such as heart attack, bacterial and viral infections, and tuberculosis.

The Nanopia wrCRP assay will be marketed by Clinical Data Inc. (Newton, MA, USA). Dr. Stein, president and CEO of Clinical Data, announced that in February 2005 the company entered into a partnering relationship with Daiichi Pure Chemicals (Tokyo, Japan) to bring novel technology to the world diagnostics market. He added that the successful marketing clearance they received for the Nanopia wrCRP assay, a proprietary product of Daiichi Chemicals, marked the first milestone in their partnership. Clinical Data will seek in vitro diagnostic (IVD) registration for the test under European regulations.

Clinical Data provides molecular services and clinical diagnostics to improve patient care. The company's Vital Diagnostics division consolidates the operations of Clinical Data Sales & Services, Inc., Vital Scientific NV, Vital Diagnostics Pty, Ltd., and Electa Lab s.r.l., which are each focused on the small-volume clinical diagnostics market worldwide. Clinical Data sells its products to around 100 companies worldwide.



Related Links:
Clinical Data
Daiichi Pure Chemicals