“Our progress toward commercializing our products, and building and expanding our quality customer base, continue on target,” said William Moffitt, Nanosphere’s president and chief executive officer. “In January we filed a de novo 510(k) submission for our HFE, or hemochromatosis genetic test, with the U.S. Food and Drug Administration (FDA).”
Moffitt continued, “Just this week we also filed a 510(k) submission for the Verigene SP, a new version of our molecular diagnostics workstation that simplifies the testing process by adding automated sample preparation. Moreover, we also commenced FDA clinical trials for our cardiac troponin assay and anticipate submitting its 510(k) application in the second quarter.”
“These new products,” he said, “along with our cystic fibrosis assay and respiratory virus panel, currently pending clearance in the FDA, will significantly add to the value of our nanotechnology-based molecular diagnostics platform,” Moffitt concluded.
Product revenue up $1.0 million for 2008 from $110,000 a year ago due to sales and rentals of the Verigene System following FDA clearance in late 2007. Revenues from grant and government contracts totaled $346,000 in 2008 compared to $1.1 million in 2007.
During the fourth quarter of 2008 revenue totaled $313,000, compared with total revenue of $188,000 in the 2007 fourth quarter, of which revenue from contracts and government grants was $138,000.
For 2008, research and development expenses increased to $23.7 million from $21.4 million in 2007. Sales, general and administrative expenses were relatively flat at $13.6 million against $13.4 million in 2007.
In the 2008 fourth quarter, research and development expenses were $6.0 million, up from $5.2 million in the same period a year-ago. Sales, general and administrative expenses decreased to $3.1 million from 2007’s $3.8 million.