Everlywell Inc. stepped back from its announcement that consumers could access at-home testing for COVID-19 starting on March 23, 2020, following a U.S. FDA update that cautioned against fraudulent at-home tests.

The pressure is rising on the Trump administration to activate the Defense Production Act (DPA) for the COVID-19 outbreak as the Senate yet again reconsiders an economic stimulus package. Sens. Brian Schatz (D-Hawaii) and Chris Murphy (D-Conn.) unveiled the Medical Supply Chain Emergency Act in an effort to force the White House to mandate the production of needed supplies, a bill that is likely to languish until Congress can move on economic relief legislation.

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.

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.

BOGOTA, Colombia – As the world turns its attention to COVID-19 and its impacts across the globe, in Latin America diseases like Chagas continue to keep scientists busy. In Argentina, researchers are working on an innovative solution to deal with a major threat to the region’s public health.

With the number of COVID-19 cases continuing to rise and with people social distancing and quarantining, at-home diagnostics and telehealth offer the means for doctors and patients to get vital answers and care without meeting face to face. Now, Los Angeles-based Scanwell Health has gained exclusive rights to license and distribute a rapid serology test from Innovita Biological Technology Co. Ltd., of Hebei, China, for at-home testing of SARS-CoV-2, the coronavirus that causes COVID-19.

LONDON – As the epicenter of the COVID-19 epidemic shifted to Europe and the number of deaths in Italy exceeded the toll in China, the EU stepped up efforts to mount a coordinated response, with a big boost for collaborative R&D funding and a call for clinical research to be pooled in multicenter, multi-arm randomized controlled trials.

PERTH, Australia – Australian digital health company Resapp Health Ltd. was down nearly 52% following news that the U.S. FDA rejected its de novo request for its smartphone application for the diagnosis and management of respiratory disease. The agency rejected the application, citing the need for additional information to demonstrate that the “clinical benefits of the device outweigh the risks,” CEO Tony Keating told analysts during a March 12 conference call on the news.