Research & Development
Cepheid passes US FDA clearance and CLIA Waiver for Xpert Xpress flu test
10 January 2018 -

Molecular diagnostics company Cepheid revealed on Tuesday the receipt of US Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for the Xpert Xpress Flu test for the detection of multiple segments of RNA.

The company said the Xpert Xpress Flu test can be performed in near-patient settings, providing rapid and accurate molecular detection of Flu A and B RNA from patient specimens, in as little as 20 minutes.

In conjunction, the company's Xpert Xpress Flu test is indicated for use with nasal swabs, in addition to nasopharyngeal (NP) swabs. Nasal swab collection is less invasive than NP swabs and allows for a more comfortable specimen collection experience for the patient.

According to the company, the new GeneXpert Xpress Systems and Xpert Xpress Flu test extend access to standardized molecular testing for any healthcare setting. Xpert Xpress Flu utilises automated real-time reverse transcription polymerase chain reaction (RT-PCR) to detect Influenza A and B RNA.

In addition, the tests capability to detect multiple segments of RNA improves strain coverage and prevents loss of sensitivity as natural variations (antigenic drift and shift) of the Influenza virus occur. The built-in reagents deliver high accuracy in an automated format with no additional confirmation testing required, concluded the company.