FDA clears Inova's Luminex-based diagnostic kit:
This article was originally published in Clinica
Executive Summary
Inova Diagnostics has gained US FDA 510(k) marketing clearance for an immunoassay that can simultaneously measure four of the most common autoantibodies - Sm, RNP, SS-A and SS-B - found in systemic autoimmune disorders. The QUANTA Plex ENA Profile 4 is based on a testing technology, called LabMAP, developed by Luminex. LabMAP, which is also cleared in the US, combines microsphere-based assays with small lasers, advanced digital signal processors and software to offer greater speed, precision and flexibility over current bioassay technologies, Inova claims. The San Diego, California firm says it plans to expand its QUANTA Plex product line. It will pay Luminex a royalty based on sales of their LabMAP-based products.
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