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Cepheid Wins FDA Approval for Xpress Flu, Flu/RSV Tests

NEW YORK (GenomeWeb) – Cepheid's Xpert Xpress Flu and Xpert Xpress Flu/RSV tests have received clearance from the US Food and Drug Administration, the firm announced today.

The tests are the first in the firm's planned line of Xpress branded tests — faster versions of the firm's Xpert test cartridges enabling test times of 30 minutes or less.

"With the arrival of fast molecular tests like Xpert Xpress Flu and Xpert Xpress Flu/RSV, patients and their healthcare providers can now expect an accurate diagnosis and have access to targeted therapies substantially more quickly [and] unnecessary treatment with antimicrobial agents can also be avoided," David Persing, Cepheid's chief medical and technology officer, said in a statement. "This supports clinical efforts to improve the patient experience, and further streamlines workflow in the laboratory, which can be particularly challenging in the midst of a busy respiratory virus season."

Xpress tests can be run on the Cepheid GeneXpert molecular diagnostics platform, which has an installed base of more than 11,000 systems in 182 countries. They are also slated to run on Cepheid's point-of-care system, Omni, although Cepheid delayed Omni's development last year in order to expedite the Xpress tests to the point-of-care market on its existing GeneXpert systems.

Cepheid has further described its intent to pursue CLIA waiver on influenza tests, similar to its waived Xpert Flu+RSV Xpress test for use on its GeneXpert Xpress system, a customized version of the GeneXpert platform consisting of a single module and a tablet computer with an ATM-like interface specifically for the CLIA-waived environment.

The Xpert product line — much of which is expected to port to the Xpress line — includes tests for healthcare-associated infections, sexual health, critical infectious disease, and oncology. The portfolio features 24 tests outside the US and 23 tests in the US, the firm noted.