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Nanosphere Gram-Negative Bacteria Test Cleared by FDA; Reports $3.4M in Preliminary Q4 Revenues

NEW YORK (GenomeWeb News) – Nanosphere today announced that the US Food and Drug Administration has cleared its test for the detection of gram-negative bacteria that cause bloodstream infections.

Additionally, the firm said that it has submitted to FDA its test for gastrointestinal infections and announced preliminary revenues of $3.4 million for the fourth quarter.

The FDA cleared Nanosphere's 14-target Verigene Gram-Negative Blood Culture Test, a rapid in vitro test that, in addition to identifying more than 90 percent of gram-negative bacteria associated with bloodstream infections, can determine resistance to commonly used antibiotics up to two days faster than other conventional methods, according to the company.

FDA cleared the Northbrook, Ill.-based firm's Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) in June 2012. Both the gram-negative and gram-positive test run on Nanosphere's Verigene molecular diagnostic platform.

The company also said that it recently submitted an application to FDA for the Verigene Enteric Pathogens Test, which is designed to help hospitals more efficiently and cost effectively diagnose patients with community-acquired diarrhea. Rapid identification of the cause of the ailment can lead to fewer hospital admissions, as well as a reduction in the use of unnecessary or inappropriate antibiotics, while providing workflow benefits to laboratories, Nanosphere said.

Lastly, the firm announced preliminary Q4 2013 revenues of $3.4 million, which would be more than double the $1.6 million in revenues recorded in the year-ago period. The figure, however, would be short of the consensus Wall Street estimate of $4.1 million in revenues for the quarter.

Nanosphere said it added 35 new customer placements in the quarter.

For full-year 2013, it said revenues are expected to increase to $10.0 million from $5.1 million in full-year 2012. The amount would miss the average analyst revenue estimate of $11.2 million. The firm said that adoption of the Verigene platform by US-based microbiology labs and the BC-GP test drove the year-over-year revenue growth.

Nanosphere said it added 161 new customers in 2013.

Nanosphere is scheduled to release its fourth quarter and full-year financial results on Feb. 12.

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