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FDA Grants 510(k) Clearance, CLIA Waiver to Cepheid Flu/RSV Test

NEW YORK (GenomeWeb) – The US Food and Drug Administration has granted 510(k) clearance and CLIA waiver to an assay for influenza and respiratory syncytial virus manufactured by Cepheid, the firm announced today.

The Xpert Flu+RSV Xpress test is the first point-of-care, CLIA-waived assay from Cepheid, and the first waived test on the market to detect and discriminate flu and RSV.

The assay runs in about one hour on the company's GeneXpert Xpress system, which is 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 company said in a statement.

"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," Cepheid CEO John Bishop said in a statement.

The test uses the same cartridge as the firm's lab-based test, which FDA cleared in November of 2014, and which fared well in one recent clinical evaluation reported by GenomeWeb.

"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," David Persing, the firm's chief medical and technology officer, said in a statement.

Cepheid described a sales force expansion, in part to support entrance into the CLIA market, in a first quarter conference call, and the the flu/RSV test is the first in a series of point-of-care tests it intends to deliver in the future. It is also developing a designated system for this market, called the Omni, which is expected to debut in the US next year.

Currently there are two other waived influenza assays commercially available. In January, a 15-minute isothermal flu A/B test from Alere was the first ever point-of-care molecular test to receive CLIA waiver. A test on Roche's PCR-based Liat point of care system, which also detects and differentiates influenza A and B, was cleared in September, and was recently reported to impact patient care in an emergency room setting. That test runs in around 20 minutes, and Roche is also developing a flu/RSV test for the Liat.

Combined flu/RSV tests from Janssen Diagnostics and Enigma Diagnostics were recently CE-marked, and the Simplexa Flu A/B & RSV Direct from Focus Diagnostics, which detects a total of 92 strains of the viruses, is cleared for use in moderately complex settings.