The U.S. FDA continues to modify its emergency use authorization (EUA) policy for testing for the SARS-CoV-2 virus, although workplace testing is still on the agency’s to-do list. The FDA’s Tim Stenzel noted on a May 6 briefing that serological tests for antibodies must now demonstrate an overall sensitivity of 90% and overall specificity of 95%, a set of standards that might challenge some tests that are available under the EUA policy.

PARIS – In the wake of the news that Swiss group Roche Holding AG received an emergency use authorization from the U.S. FDA as well as a CE-IVD certification for the Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in people previously exposed to SARS-CoV-2 that causes the COVID-19 disease, the company unveiled its plans for the launch of the product.

The capacity of U.S. medical providers and testing capacity for the unfolding COVID-19 pandemic continues to be sorely tested. But there is now a new route for people to pursue serological testing to detect who has already been exposed to the SARS-CoV-2 virus.

HONG KONG – Israeli companies have produced some promising med-tech solutions for COVID-19, and the artificial intelligence space is turning out to be a particularly strong area of expertise for that tiny but mighty nation. One of the four health maintenance organizations (HMO) in Israel, Maccabi Healthcare Services, has deployed a new AI-powered algorithm that identifies individuals estimated to be at the highest risk of severe COVID-19 complications due to pre-existing conditions and other health factors.

LONDON – With COVID-19 infection varying in severity from asymptomatic to lethal the search is now underway for biomarkers to predict which patients are most at risk of suffering severe disease. As one possibility, Menarini Silicon Biosystems (MSB) is using its Cellsearch liquid biopsy technology to capture and count circulating endothelial cells. Meanwhile, Oxford Biodynamics plc is applying its Episwitch platform to find prognostic and predictive epigenetic markers.

Roche Holding AG, of Basel, Switzerland, has garnered U.S. FDA authorization for emergency use of a test to determine whether people have been infected with the novel coronavirus fueling the COVID-19 pandemic. The Swiss health care giant, which also makes molecular tests to detect active COVID-19 infection, claims its Elecsys Anti-SARS-CoV-2 antibody test accurately identifies COVID-19 antibodies in the blood 100% of the time, 14 days post-infection.

Researchers in Guangzhou, China, have developed a nanoparticle-based lateral flow immunoassay that quickly and accurately detects antibodies to the SARS-CoV-2 virus that causes COVID-19. The current test, which works in a similar manner to a pregnancy test, detects IgG antibodies in blood in less than 10 minutes. A proof-of-concept study appeared in Analytical Chemistry this week.

PERTH, Australia – Australia is taking several measures to increase diagnostic testing for COVID-19 and rolling out a national surveillance app as it prepares to relax social distancing measures and get back to work.

Bio-Rad Laboratories Inc. has launched its SARS-CoV-2 Total Ab test, which is a blood-based assay to identify all the antibodies that are developed by the human body in response to the novel coronavirus SARS-CoV-2. Companies have been racing to offer serological tests that work to detect the antibodies developed during a COVID-19 infection that remain present in the blood after the initial infection clears.