Nanosphere has submitted a 510(k) application to the FDA for its influenza and respiratory syncytial virus (RSV) test to run on the Verigene SP, with complete sample-to-result automation.
The company said that Verigene SP will provide automated sample-to-result molecular diagnostics capabilities in a multiplexed, random-access, modular system, utilizing the same imaging technology as the first generation Verigene.
Nanosphere plans to submit additional FDA applications for each of its previously 510(k) cleared assays to allow their use on the new Verigene SP.
William Moffitt, president and CEO of Nanosphere, said: We are pleased to reach this milestone and look forward to completing the regulatory process and bringing our respiratory assay to market on this highly differentiated platform.
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The market has strongly signaled its need for a flu test that provides greater sensitivity than currently available rapid tests, combined with optimized ease of use and turnaround time not found in either traditional culture methods or the currently available molecular tests. Our respiratory panel running on the Verigene SP directly addresses these market needs, he added.
