Meridian Bioscience gets FDA clearance to add swine flu claims to rapid flu testing device

CINCINNATI, Ohio — Meridian Bioscience Inc. has received clearance from the U.S. Food and Drug Administration to add two strains of 2009 H1N1 Influenza A virus – swine flu — to the sensitivity claims made by its TRU FLU flu testing devices.

TRU FLU is a rapid test that identifies influenza A and B in human specimens, Meridian Bioscience said in a written statement. One of the nice things about TRU FLU is it offers a closed test system, containing specimens inside the device. That means the testing device could help prevent the spread of the flu virus.

While the performance characteristics of the device with swine flu-positive specimens have not been established, “the analytical sensitivity claims with the two strains adds an additional important product benefit,” the company said.

“Meridian is working diligently to provide our global customers who are facing an influenza pandemic with product features that will assist them from a testing standpoint,” said Meridian CEO John A. Kraeutler in the statement. “We must provide our customers with tools that allow them to do their jobs in a rapid, safe and effective manner, thus improving patient care.”

On Tuesday, Meridian Bioscience repeated its fiscal 2009 guidance of net sales of between $140 million and $144 million, and per share-diluted earnings of between 77 cents and 81 cents for the year ending Sept. 30. But the company also said it expects a rise of between 15 percent and 20 percent in net income over the coming year. That’s diluted earnings-per-share of between 90 cents and 95 cents on net sales between $160 million and $165 million.

“While the uncertainties of the economy are still a concern for most businesses, our infectious disease business appears to be more resistant to these downside forces,” Kraeutler said in his company’s Tuesday statement. “As is typical, our fiscal 2010 estimates do not consider additional revenues and income that might result from the launch of new tests and new technologies during the year. Likewise, our respiratory testing revenues are projected to increase at a moderate rate, and we have avoided speculation on the potential impact of increased flu testing due to the prevalence of the H1N1 virus.”

Meridian Bioscience shares were down 22 cents, or less than 1 percent, to $25.22 in mid-afternoon trading on the NASDAQ Stock Exchange.