FDA Clearance for Two New Rapid Tests for the Detection of Influenza and RSV
Meridian Bioscience, Inc. (NASDAQ:VIVO) has announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market two new upper respiratory tests: TRU FLU ® and TRU RSV ®. These tests are based upon a new rapid test technology that features improved safety and space savings. TRU FLU ® detects both influenza A and influenza B while TRU RSV ® detects for respiratory syncytial virus. These companion tests are ideal for the diagnosis of common upper respiratory diseases.
According to the Centers for Disease Control and Prevention (CDC), up to 60 million people in the United States will contract influenza this year. More that 200,000 people are likely to be hospitalized due to the disease and approximately 36,000 people die each year from influenza. RSV is a virus which also circulates during the same time period, and is the most common cause of severe respiratory illness in small children. Influenza and RSV tests are often run simultaneously on the same patient specimens. The rapid diagnosis of influenza offers physicians the ability to treat promptly patients with antiviral medications and to avoid the prescribing of antibiotics that have no effect on influenza or RSV.
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