An influenza diagnostic device – designed to rapidly diagnose viral infections at the doctor’s office – has received approval from the US Food and Drug Administration (FDA). The Xpert Flu+RSV Xpress test is capable of using molecular diagnostic methods to screen for Influenza A, Influenza B and respiratory syncytial virus (RSV).
Along with the FDA approval, Cepheid also snagged a Clinical Laboratory Improvement Amendments (CLIA) waver for the test, which is designed to run on the company’s GeneXpert Express tablet system. The CLIA waver is only granted to labs that perform simple diagnostic tests – such as the glucose meter test – in which the risk of error is very low. According to a statement released by the company, the technology is based upon Cepheid’s lab-based Flu/RSV XC diagnostic, and can produce results in about 1 hour.
“There are about 1 billion visits each year to doctors’ offices in the US but until recently, CLIA waived testing sites haven’t been able to access certain diagnostics found in hospitals or reference labs,” said John Bishop, CEO of Cepheid. “We believe that point of care testing will be well served by the significant step up in accuracy and multiplexing capability of PCR-based molecular assays and are committed to broadening access to these important tests.”
The Xpert Flu+RSV Xpress test is not the only point-of-care diagnostic in development by Cepheid; the company has plans to offer a number of doctor’s office-based tests over the next few years. In early 2016, the company is set to market their point-of-care diagnostic system, GeneXpert Omni, to markets outside of the US. The device – which is capable of detecting a range of infectious diseases – is set to be available in the US in late 2016.
The GeneXpert Omni could be a more valuable tool for clinicians when compared to currently-available molecular diagnostics, because the system allows for the running of up to 80 simultaneous tests. Cepheid plans to offer 18 distinct tests to the US market and 23 to the international medical community.
“Cepheid expects to launch faster Xpert tests in conjunction with the availability of the GeneXpert Omni,” commented David Persing, the company’s CMO. “Compared to an average run-time of about an hour today, we are further optimizing every stage within the cartridge with a goal of delivering test results in as little as 15 minutes, starting with our Xpert Group A Strep assay.”
- Cepheid nabs FDA OK for point-of-care flu test – http://www.fiercemedicaldevices.com/story/cepheid-nabs-fda-ok-point-care-flu-test/2015-12-07
- Cepheid Receives FDA CLIA Waiver for Xpert Flu+RSV Xpress Test – http://www.fiercemedicaldevices.com/press-releases/cepheid-receives-fda-clia-waiver-xpert-flursv-xpress-test