South Korean researchers from the Gwangju Institute of Science and Technology (GIST) developed a new fluorescence-based lateral-flow immunoassay (LFI) enhanced with gold nanorod (GNR)-based probes to detect viral infections like the influenza A virus.
The availability of rapid antigen tests for the COVID-19 pandemic has been far short of ideal in recent weeks despite a recent order by the Biden administration for half a billion tests. The question of whether additional federal dollars are forthcoming for additional tests is up in the air, however, due to congressional concerns that there is roughly $800 million in unspent federal dollars, a signal that any additional monies might not be made available any time in the near term.
Bond Digital Health Ltd. landed £1 million (US$1.3 million) from investors to expand development of its Transform data management system for lateral flow diagnostic tests. The technology connects to an app that captures data from lateral flow assays in self-testing settings. The results are then shared to a dashboard that can be monitored by the platform admin. The new investment included equity funding from the Development Bank of Wales and high-net-worth investment service Wealth Club. In addition to the current round, Bond is aiming to raise a further £500,000 by January.
Iceni Diagnostics Ltd. is accelerating efforts to commercialize a diagnostic for detecting COVID-19 using sugars rather than antibodies. Lateral flow diagnostics (LFDs) have been widely used during the COVID-19 pandemic to diagnose people with an active infection. The tests use antibodies, which attach to the SARS-COV-2 virus but Iceni’s Host-Pathogen Glycan Recognition technology has been touted as a potential alternative due to its polymer approach.
The U.S. National Institutes of Health reported Oct. 14 that it has awarded contracts in the amount of $77.7 million for development and manufacture of a dozen new rapid tests for the SARS-CoV-2 virus. The monies were awarded under the NIH’s Rapid Development of Diagnostics (RADx) program, and will add seven viral antigen detection and five viral RNA detection tests to the suite of offerings. all with an eye toward more rapid turn-around of test results. The news of the new round of RADx grants was followed by 24 hours the announcement that the Department of Health and Human Services has extended the public health emergency (PHE) for the COVID-19 pandemic for another three months.
Advocates have continued to press for more widespread use of rapid antigen tests in the home as a primary instrument for returning to economic normalcy, and the FDA has granted an emergency use authorization (EUA) to Acon Laboratories Inc., of San Diego, for the company’s Flowflex rapid antigen test for at-home use. According to the FDA, Acon said the COVID-19 test will be produced at a rate of 200 million a month by February 2022, a clip that should go a long way toward restoring vigor to a lagging U.S. economy.
LONDON – U.K. rapid diagnostics specialist Mologic Ltd. has been acquired by a group of philanthropists led by George Soros’ Economic Development Fund and the Bill & Melinda Gates Foundation, and will be turned from a for-profit company to a social enterprise. The aim is to use the change in status to expand access to low-cost point-of-care testing for tropical diseases, including dengue, bilharzia and river blindness, as well at COVID-19. The name Mologic will be changed to Global Access Health (GAH), with the philanthropic owners saying they are to invest at least $41 million in the deal.
LONDON – Final results of the community pilot in Liverpool, U.K., that used the controversial Innova Medical Group Inc. lateral flow device to test all comers for COVID-19, show new cases fell by 21% compared to other areas of the U.K., because infections were detected early and people quarantined sooner.
The FDA issued a June 10 warning letter to Innova Medical Group Inc. in connection with the company’s rapid antigen tests for the SARS-CoV-2 virus, an action that accompanies a class I recall and a safety communication.
If the SARS-CoV-2 virus has achieved anything useful in the world of in vitro diagnostics, it’s that the associated pandemic has shone a bright and unsparing light on the respective merits of diagnostic and surveillance testing. Harvard University’s Michael Mina, an assistant professor of epidemiology, was one of several academic researchers who took up the gauntlet yet again in opposition to what they characterized as a gross misunderstanding of the respective roles of these types of tests, a misunderstanding they said must be addressed if the pandemic is to be corralled.
