California-based molecular diagnostics company Cepheid (CPHD) has received the U.S. Food & Drug Administration (FDA) clearance for the sale of its on-demand molecular test – Xpert Flu/RSV XC – in the U.S. market.
The Xpert Flu/RSV XC test can accurately detect the presence of Flu A, Flu B as well as respiratory syncytial virus (RSV) infection in a patient's body. The test runs on Cepheid's proprietary molecular diagnostic system – GeneXpert.
Last September, Cepheid released the Xpert Flu/RSV XC test in the European market, where the test is sold as a CE-IVD product under the European Directive on In Vitro Diagnostic Medical Devices.
Detection of influenza viruses, which cause contagious respiratory ailments and often have adverse effects on young children and others with weak immune system, is a difficult task. If not contained at an earlier stage, such viruses can result in flu outbreaks which may take a severe turn further, in absence of proper precautions. One such example is the Ebola virus epidemic that fatally affected multiple countries in West Africa this year.
RSV also refers to a common pathogen that may lead to a varied range of respiratory disorders in children and aged people and can also cause infants to suffer from severe health issues like bronchiolitis and pneumonia.
Based on the above facts and with growing public awareness, the healthcare system has been in dire need of an accurate and expedient test for flu and RSV infection. Cepheid's Xpert Flu/RSV XC test comes as an apt solution amid such crises.
Currently, the Microbiology Research Team at Geisinger Health System is planning a pilot testing program – FluWorks, which will provide Xpert Flu/RSV XC test results to be instantly delivered to doctors and patients via electronic health records, web portals, or text messaging.
Cepheid is eagerly waiting for this program to work out, as it should help establish the efficacy of the Xpert Flu/RSV XC test in accurate and timely detection of viruses.
Cepheid plans to apply this unique test for quick examination of patients showing symptoms of influenza at Emergency Departments, out-patient clinics, and in selected Urgent Care Clinics, effective this winter.
Zacks Rank
Currently Cepheid retains a Zacks Rank #3 (Hold). Some well-placed stocks worth reckoning in the medical instruments industry are AngioDynamics Inc. (ANGO), EnteroMedics Inc. (ETRM) and Fluidigm Corporation (FLDM). All the three stocks sport a Zacks Rank #1 (Strong Buy).
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