- Cepheid said Tuesday it's developing a single test to detect SARS-CoV-2, Flu A, Flu B and RSV (respiratory syncytial virus) with the aim of making it available for the next flu season.
- The Danaher molecular diagnostics subsidiary said it plans to pursue the FDA's emergency use authorization pathway for the four-in-one combination test.
- The test, which aims to produce results in 35 minutes, is designed for use on the company's cartridge-based GeneXpert System, with instruments configured for either patient point-of-care or high-volume laboratory testing.
Along with products from Abbott and Roche, Cepheid’s Xpert Xpress is among the most widely used diagnostic tests for SARS-CoV-2, the virus that causes COVID-19 disease. The Sunnyvale, California-based company in March was the first manufacturer to gain FDA emergency use authorization for a point-of-care coronavirus test.
Cepheid is gearing for its new test to be ready in time for the next flu season, when public health experts are bracing for a potential spike in COVID-19 cases. Even now, more than a dozen states are seeing increases in the number of cases, as social distancing rules are relaxed and businesses reopen across the United States, according to Johns Hopkins data.
The company said the viral infections targeted by its combination test, SARS-CoV-2, Flu A, Flu B and RSV, have similar clinical presentations but require different treatment approaches. The new test is designed to differentiate among the four virus types from a single patient sample. It is intended for use on its more than 25,000 GeneXpert systems installed worldwide.
U.S. laboratories are scaling up their capacity to meet demand for COVID-19 testing, considered critical to safely reopening the country. A recent survey by the Association for Molecular Pathology found 42% of commercial laboratories are planning to be able to process more than 2,000 tests a day, compared to 14% of labs that could handle that volume when the survey was conducted in late April to early May.
Danaher Chief Executive Thomas Joyce in May said the company had shipped more than two million test cartridges since the launch of the company's rapid molecular test for COVID-19 in March. Going forward, the company expects to be able to ship more than six million tests per quarter.