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Meso Scale Gains Its First FDA Clearance for IVD

NEW YORK (360Dx) – Meso Scale Diagnostic today announced it received its first clearance from the US Food and Drug Administration for an in vitro diagnostic.

The agency cleared Meso Scale's conventional C-reactive protein assay, which is based on the company's Multi-Array technology. The technology has been used in life science research applications for about 20 years. CRP is a diagnostic biomarker that has taken on importance for its applications in personalized medicine and companion diagnostics, Meso Scale said.

The cleared assay system includes the Meso Sector S 700 for the IVD determination of analytes in body fluids. The instrument uses the same hardware and firmware as the Meso Sector S 600, which is sold for life science research.

Meso Scale "now has a cleared platform, which lowers the barrier to commercialization of future tests and provides an attractive alternative to traditional diagnostic test systems," James Wilbur, general manager of Meso Scale Discovery, a division of Meso Scale Diagnostic, said in a statement.