Binax Announces FDA 510(k) Clearance of NOW Influenza A & B Rapid Test for Identification and Differentiation between Flu A and Flu B on One Simple Test
PORTLAND, Maine -- Binax, Inc., a developer of rapid diagnostic tests, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the NOW(R) Influenza A & B test. This latest test from Binax replaces two individual tests, NOW Flu A and NOW Flu B, and complements the company's portfolio of diagnostic tests for respiratory tract infections.
Influenza infects an estimated 10-20 percent of the U.S. population annually, resulting in 114,000 hospitalizations and 36,000 deaths. The flu is caused by a virus that affects people of all ages -- not just children, the elderly or immunocompromised individuals. In fact, influenza infection can predispose one to a more serious co-infection with Streptococcus pneumoniae or Staphylococcus aureus.
Traditional methods to identify the flu provide results in two to 10 days, whereas rapid tests require only 15 minutes. NOW Influenza A & B is an easy, one-step test that is as simple to read as a pregnancy test. Performance is comparable to NOW Flu A and NOW Flu B tests currently on the market. The advantage of the new test is the ability to identify both flu A and flu B and differentiate between the two using one simple device. "Rapid diagnosis of influenza is critical for patient management during the winter months," says Michael Musgnug, product manager. "A positive result identifies those patients who do not require antibiotics and who should be monitored more closely for secondary infection."
Source: Binax, Inc.
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