NEW YORK (GenomeWeb News) – Nanosphere today said that the US Food and Drug Administration has notified the firm that its Verigene SP respiratory virus panel has been categorized as "moderate complexity" under the Clinical Laboratory Improvement Amendments of 1988.
The test runs on the firm's Verigene SP molecular diagnostics system, the newer version of its flagship Verigene platform.
The moderate complexity designation will allow the test to be run in more settings than under its previous designation of "high complexity" on the older system. Nanosphere noted that the respiratory virus panel for the Verigene SP is the first of its tests to receive the moderate complexity designation.
The Northbrook, Ill.-based firm said that it intends to seek the moderate complexity designation for all of its assays.