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.
Business as usual only three months ago has transformed into health care industry overdrive as biopharma and med-tech companies scramble to test and scale-up treatments, vaccines and diagnostics to address COVID-19.
Zurich-based startup Ava Science Inc. recently issued a public call for partners and funding to further research the potential usefulness of its fertility wearable, known as Ava Bracelet, during the COVID-19 pandemic.
With an eye toward helping those potentially suffering from COVID-19, Mountain View, Calif.-based Alivecor Inc. said its six-lead electrocardiogram (ECG), known as the Kardiamobile 6L, now is allowed for use in the measurement of a patient's QTc and detection of QT prolongation. The Kardiamobile 6L enables patients to take a six-lead ECG outside a doctor’s office.
LONDON – COVID-19 excepted, biomedical research projects and clinical trials are grinding to a halt across Europe, as universities shut down and administrators stop any work not related to the coronavirus.
HONG KONG – Korean biopharma Celltrion Inc. said it’s halfway through the process of creating a super antibody to reign in the COVID-19 novel coronavirus that has claimed almost 13,000 lives globally.
PERTH, Australia – Australia’s Atomo Diagnostics Pty. Ltd. is preparing to raise AU$30 million (US$11.7 million) in an initial public offering on Australia’s Securities Exchange (ASX) that will enable it to ramp up manufacturing for rapid self-tests for COVID-19. The Sydney-based company is working with several multinational diagnostics companies to develop the new COVID-19 blood tests, which would be integrated with Atomo’s existing rapid test platform currently used for HIV screening.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genmark Dx.