Cepheid's Xpert Flu+RSV Xpress test gains FDA waiver
Both the 510(k) clearance and the CLIA waiver apply to the GeneXpert Xpress System. This system is tailored to use one module and one tablet computer that has an ATM interface. This is just for the waived environment of the CLIA.
"There are more than 1 billion visits annually to physicians' offices in the United States and yet, until recently, CLIA waived testing sites have not had access to the same levels of accuracy found in sophisticated hospital or reference laboratories," Cepheid's Chairman and Chief Executive Officer John Bishop said. "We believe that point-of-care testing will be well-served by the significant step up in accuracy and multiplexing capability of [polymerase chain reaction] PCR-based molecular assays and are committed to broadening access to these important tests."
This is the first time that a PCR panel test has gained a CLIA waiver from the FDA. Cepheid plans for this to be just the first of several molecular tests that the company plans to develop throughout upcoming years.
"The Flu+RSV Xpress test uses the same design as our lab-based Flu/RSV XC test, which has already shown in several studies to provide performance that meets or exceeds that of other conventional molecular testing run in hospital or reference labs," Dr. David Persing, Cepheid's chief medical and technology officer, said. "Novel design features of this test include high-level multiplexing, redundant target segments, and extended coverage for human and avian influenza strains -- a first in the industry for the CLIA-waived market and an important step towards pandemic preparedness."