The granting of emergency use authorization by the U.S. FDA to Roche AG for its four-in-one molecular test for SARS-CoV-2, Influenza A/B viruses and respiratory syncytial virus will allow the company to quickly bring the test to near-patient care environments ahead of the flu season, to address a real need in the marketplace, Ian Parfrement, head of the point of care customer area, at Roche Diagnostics, told BioWorld.
Joining a growing number of diagnostics companies mobilizing to minimize the spread of monkeypox, Novacyt SA and Seegene Inc. reported they have developed new polymerase chain reaction (PCR) assays to quickly diagnose the disease this week. Roche Holding AG released three monkeypox tests for research use in late May. Abbott Laboratories and Becton Dickinson & Co. have similar plans. Stanford Medicine made its own diagnostic available to its patients last week.
The Xpert MTB/XDR test developed by the Foundation for Innovative New Diagnostics (FIND) and Cepheid Inc. quickly indicates whether a patient has a dangerous – and rapidly increasing – strain of multidrug resistant tuberculosis (TB). The new test enables clinicians to return results in 90 minutes and see immediately whether the pathogen would respond to standard first- or second-line therapies.
The U.S. FDA has granted an emergency use authorization (EUA) to Cepheid Inc., of Sunnyvale, Calif., for a rapid molecular diagnostic to detect SARS-CoV-2, the virus that causes COVID-19. The Xpert Xpress SARS-CoV-2 test is designed for the qualitative detection of the novel coronavirus and runs on the company’s automated Genexpert systems, with a turnaround time of about 45 minutes.
