Sunnyvale, California-based molecular diagnostics company, Cepheid, has just announced the US Food and Drug Administration has granted marketing clearance for its proprietary Xpert® Flu/RSV XC, a breakthrough diagnostic tool that can differentiate between Flu A, B, and RSV infections. The test utilizes the company’s GeneXpert® System, the world leader in molecular diagnostic platforms, boasting over 7,500 installed systems across the globe. This tool will mostly benefit pediatric clients, as they are most prone to complications and even death from the flu. RSV infections are particularly important to detect as it is known to be the leading cause of pneumonia and bronchiolitis in infants younger than 1 year old. Effective treatment is reliant on an accurate diagnosis.
According to the company’s Chairman and CEO, John Bishop, influenza strains are constantly evolving and tend to be unpredictable in terms of their ability to cause a serious outbreak. Recent media hype over Enterovirus D68 and Ebola have heightened the general public’s awareness of disease transmission, which underscores the need for reliable and more specific diagnostic tests. The flu is of particular concern as it is one of the most easily transmitted respiratory diseases, as an infected individual is infectious up to a week after getting sick.
Along with marketing clearance comes a pilot testing program for the test, called FluWorks©, to be conducted by Dr. Donna Wolk and Dr. Raquel Martinez of the Geisinger Health System. Through this program, test results from the Xpert Flu/RSV XC will be conveniently and promptly sent to physicians and patients through electronic health records, web portal, or text messaging. Dr. Wolk shared they are planning to leverage this new tool this winter “flu season” for the quick and accurate diagnosis of patients at Emergency Departments, out-patient clinics, and in selected Urgent Care Clinics.
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“We employed a novel in silico approach to identify multiple complementary target segments to avoid the effects of seasonal genetic drift and to anticipate emerging novel influenza strains. Though simple to perform, Xpert Flu/RSV XC is a highly multiplexed, state-of-the-art test for fast and accurate detection and differentiation of Flu A, Flu B, and RSV infection,” said David Persing, M.D., Ph.D., Cepheid’s Chief Medical and Technology Officer. “This test may also become a valuable asset in efforts toward pandemic preparedness, because it was designed from its inception to provide unprecedented coverage of both human and avian influenza strains.”
Cepheid’s Xpert Flu/RSV XC is set to begin shipping out orders this month. To learn more about this product, the company’s GeneXpert Systems, and their portfolio of molecular diagnostic tests, visit www.cepheid.com.