Cepheid (NASDAQ: CPHD) announced today the release of Xpert® Flu/RSV XC, an on-demand molecular test for rapid, accurate and reliable determination of Flu A, Flu B, and differentiation of RSV infection. The test will be marketed as a CE-IVD product under the European Directive on In Vitro Diagnostic Medical Devices, bringing the total number of tests available to eighteen. Xpert Flu/RSV XC runs on Cepheid's GeneXpert® System, the world's leading molecular diagnostic platform with more than 7,000 systems installed to date.
"Influenza strains are notoriously unpredictable and the severity of flu outbreaks can vary widely from season to season," said John Bishop, Cepheid's Chairman and Chief Executive Officer. "While no one can know exactly which influenza strains will show up in their clinics and emergency rooms, with Xpert Flu/RSV XC hospitals and clinicians can be prepared to reliably diagnose and differentiate influenza strains in real-time."
The flu is a contagious respiratory illness caused by influenza viruses that infect the nose, throat, and lungs. It can cause mild to severe illness, and at times can lead to death. Patients infected with the flu may be able to infect others beginning one day before symptoms develop and up to five to seven days after becoming sick. Some people, especially young children and people with weakened immune systems, might be able to infect others for a longer time.1
Respiratory syncytial virus (RSV) is a very common virus that leads to a wide range of respiratory symptoms in children and older adults. It can be more serious in young children, especially those in certain high-risk groups. Most infants have had an RSV infection by age two.2 RSV is the most common cause of bronchiolitis and pneumonia among infants and children under one year of age.3
"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 rapid 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 avian influenza strains."
The severity of a flu outbreak can vary widely from one season to the next depending on which flu viruses are spreading, how many people get vaccinated, and how well the flu vaccine is matched to the flu viruses that are currently causing illness.
"Rapid identification of respiratory pathogens can help improve management of patient health. To be cost-effective and to break the chain of disease contagion, the diagnosis of influenza and other respiratory infections must be rapid, sensitive and specific," stated Dr. Remi Charrel, M.D., Ph.D., in a peer-reviewed ESCV 2014 abstract.
Xpert Flu/RSV XC begins shipping this month as a CE-IVD Mark product. For more information on Cepheid's GeneXpert Systems or a complete menu of CE-IVD Xpert tests, visit www.cepheidinternational.com.