Nanosphere, Inc. (Nanosphere), a molecular diagnostics company, has submitted its Verigene SP respiratory syncytial Virus (RSV) Test for FDA 510(K) approval. The device with complete sample-to-result automation is intended for influenza and respiratory syncytial virus detection.
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, said William Moffitt, Nanosphere’s president and chief executive officer. Mr. Moffitt added: 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.
The Verigene SP will be operated in a multiplexed, random-access, modular system utilizing the same imaging technology as the first generation Verigene. This allows for complimentary or stand alone integration into both microbiology and molecular laboratories. Moreover, the company plans to submit additional FDA applications for all its previously 510(k) cleared assays to allow their use on the new Verigene SP. The assays are a thrombophilia or hypercoagulation panel, a warfarin metabolism assay and a cystic fibrosis panel.