Nanosphere, Inc. (Nasdaq:NSPH), a leader in the development and commercialization of advanced molecular diagnostics systems, received notification from the U.S. Food and Drug Administration (FDA) that its respiratory virus panel (RVNATSP) performed on the Verigene SP System has been categorized as "Moderate Complexity" under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
The "Moderate Complexity" designation allows the test to be run in more settings by a broader group of operators.
The RVNATSP assay on the Verigene SP is the first Nanosphere test categorized as "Moderate Complexity" by the FDA. Nanosphere's previously cleared FDA products have been categorized as "High Complexity" and run on the original Verigene system. The company plans to file all of its previously cleared and future assays on the Verigene SP, which automates sample preparation, and should enable more tests to be categorized as "Moderate Complexity."
"This CLIA categorization is another validation of the value of our technology and its ease of use," said William Moffitt, Nanosphere's President and Chief Executive Officer. "It broadens our market for the Verigene SP and provides customers with the first 'Moderate Complexity' molecular flu test," Mr. Moffitt explained.
The Verigene® System is a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid and protein targets of interest for a variety of applications. The Verigene® SP System adds automated sample preparation to the original Verigene® System, allowing for sample-to-result capabilities.