Benzinga | Sep 29, 2020 07:07AM EDT

Danaher's Cepheid Receives Emergency Use Authorization For SARS-CoV-2, Flu A, Flu B And RSV Combination Test

SUNNYVALE, Calif., Sept. 29, 2020 /PRNewswire/ -- Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert(r) XpressSARS-CoV-2/Flu/RSV, a rapid molecular diagnostic test for qualitative detection of the viruses causing COVID-19, Flu A, Flu B, and RSV infections from a single patient sample. The four-in-one test is designed for use on any ofCepheid'sover 26,000 GeneXpert(r)Systems placed worldwide, with results delivered in approximately 36 minutes.

"Things may get complicated this respiratory season as clinicians encounter a range of viral infections with symptoms overlapping with COVID-19, including Flu A, Flu B, and respiratory syncytial virus," said Dr.David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid."The ability to run a single, highly sensitive test that detects all four viruses in a syndromic panel provides actionable results and helps to alleviate pressure on our healthcare system."

Cepheid's previously announced capacity expansion program, supported by parent company Danaher Corporation, was designed in part to address anticipated demand for XpertXpressSARS-CoV-2/Flu/RSV. Cepheid expects the first impact of the program in the fourth quarter of 2020 with additional capacity ramping through 2021.

"The dramatic impact of SARS-CoV-2 has been felt by us all, and we understand that a reliable supply of SARS-CoV-2 tests is critical to the communities our healthcare institutions serve -- for the coming Flu season and beyond," saidCepheid President Warren Kocmond. "Another goal of the capacity expansion program is to ensure supply continuity of not only our 4-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 new EUA combination test is expected to begin shipping to US customers this week, with expected CE-IVD availability in November.

Visit www.cepheid.com/coronavirus for more information, videos, package inserts and more.