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Cepheid Rapid Flu/RSV Test Receives CE Mark

NEW YORK (GenomeWeb) – Cepheid has received CE marking on a rapid test for influenza and respiratory syncytial virus, the firm announced today, and the new test is available immediately in all countries recognizing the CE mark.

The Xpert Xpress Flu/RSV runs on the firm's GeneXpert platform and provides results in about 30 minutes. The assay features a novel design employing multiple targets for each virus, with redundancy providing high sensitivity and mitigating the impact of seasonal drift, the firm said.

"With the arrival of fast molecular tests like Xpert Xpress Flu/RSV, patients and their healthcare providers can now expect an accurate diagnosis, and access to targeted therapies substantially more quickly," 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."

The assay is the first rapid test in a proposed line which will use the same GeneXpert platform and cartridge design but take advantage of new, faster chemistries. The proposed menu of Xpress tests was previously reported to include Group A Strep, Group B Strep, human papillomavirus, pertussis, chlamydia and gonorrhea, and vaginitis/vaginosis.

Cepheid received US Food and Drug Administration clearance and CLIA waiver in December for a one-hour test called Xpert Flu+RSV Xpress. The firm now intends to bring the rapid version to the US for CLIA waiver, where it could compete with the likes of the Roche Liat and Alere i Flu/RSV tests in the point-of-care market.

The firm noted in its first quarter 2016 earnings report that, based on early market feedback and changing clinical practices, it had identified an opportunity to broaden its penetration in the US point-of-care market by leveraging its broad test menu and accelerating the development of certain Xpert Xpress tests. At that time Cepheid said it was targeting the 2017/2018 flu season to deliver the first Xpert Xpress tests for the CLIA-waived market, and that waiver of the Xpert Flu+RSV Xpress test helped guide the change in course, enhancing confidence that the firm could bring other Xpress tests through the regulatory process as well.