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Cepheid Receives CE Mark for SARS-CoV-2, Flu A/B, RSV Combination Test

NEW YORK ─ Sunnyvale, California-based Cepheid on Tuesday announced it has obtained CE-IVD marking for its Xpert Xpress SARS-CoV-2/Flu/RSV rapid molecular diagnostic test to detect from a single patient sample the viruses that cause COVID-19, Flu A, Flu B, and RSV infections.

The test, which received US Food & Drug Administration Emergency Use Authorization in September, is now available in the European Union and other markets that recognize CE-IVD marking.

Cepheid said that the 4-in-1 test runs on any of almost 30,000 GeneXpert Systems placed worldwide, which provide results in approximately 36 minutes.

Its GeneXpert Systems are configured to operate with a varying number of modules, or test bays, to meet variations in volume requirements. The company's largest GeneXpert System is configured with up to 80 modules, meaning up to 80 tests can operate independently at any given time with a capacity of about 2,000 tests per day, the firm said.

Cepheid noted that it has announced a capacity expansion program, supported by parent company Danaher, designed in part to address anticipated demand for Xpert Xpress SARS-CoV-2/Flu/RSV.

"Another goal of the capacity expansion program is to ensure supply continuity of not only our four-plex combination test for SARS-CoV-2, Flu A&B, and RSV, but the entire portfolio of critical tests Cepheid supplies, including tests for tuberculosis, MRSA, C. difficile, CT/NG, Strep A, and many more," the firm's President Warren Kocmond said in a statement.

Cepheid said it expects the first impact of the expansion program in the fourth quarter with additional capacity ramping through 2021.