Assays Detect Nanoparticles Associated with Pathologic Calcification

(Tampa, FL, USA) announced that the two assays, the Nano-Capture enzyme-linked immunosorbant assay (ELISA) assay and the Nano-Sero IgG ELISA--currently manufactured by the company's subsidiary in Kuopio, Finland--will be made in the United States for use in clinical trials, U.S. Food and Drug Administration (FDA; Rockville, MD, USA) approval, and expanded distribution. The company believes that its diagnostics will serve as biomarkers allowing for earlier identification, diagnosis, and treatment of diseases that are characterized by pathologic calcification.

"The technology transfer of our proprietary diagnostic to a FDA-approved U.S. manufacturing facility is a hallmark event for our company,” commented Dr. Benedict Maniscalco, Nanobac's co-chair and chief medical officer. "Bringing our manufacturing to the United States will potentially allow us to make our diagnostic a standard-of-care in U.S. Healthcare and represents a key step to transition from a research-oriented company to one that rapidly develops products for sales and marketing worldwide.”


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Nanobac Pharmaceuticals
U.S. Food and Drug Administration