Adarza Biosystems Inc.’s Ziva platform can simultaneously detect hundreds of proteins, antibodies, or substrates from a single drop of blood, plasma or serum, providing insight into an individual’s immune response. That could be critical for both surveillance and diagnostic purposes as the nation prepares for a likely second wave of the novel coronavirus in the fall when multiple respiratory pathogens will be circulating.
PERTH, Australia – Sydney-based Speedx Pty. Ltd. has signed a global distribution deal with Roche AG, through which the latter will sell Speedx’s Resistanceplus MG and Resistanceplus GC molecular tests for detecting antimicrobial resistance to Mycoplasma genitalium (Mgen) and gonorrhea, respectively.
The COVID-19 pandemic has gripped the conversation regarding diagnostic and surveillance testing, but stakeholders nonetheless saw fit to populate the docket for the FDA’s proposal to down-classify tests for the human immunodeficiency virus (HIV) to class II. One of the themes of the feedback was that the proposal excludes a few key items, such as quantitative nucleic acid tests and testing for viral load monitoring, leaving the FDA with some difficult decisions to make.
LONDON – Noscendo GmbH closed a series A round to finance the commercialization of its next generation DNA sequencing test for the fast diagnosis of bloodstream infections. At the same time, the company reported the start of operations at a new testing lab.
Since April 10, 2020, the FDA has issued emergency use authorizations (EUAs) to several companies that make blood purification devices that can clear excess cytokines in the blood of patients with COVID-19. Monmouth Junction, N.J.-based Cytosorbents Corp.; Lakewood, Colo.-based Terumo BCT Inc.; and Marker Therapeutics AG, a subsidiary of Marker AG, of Zug, Switzerland, have all recently received EUAs for use of their products in adults with confirmed COVID-19 infections who are admitted to intensive care.
“Vaccines, obviously, are the ultimate solution for pandemics,” Rino Rappuoli told BioWorld. They have, he added, “already eliminated a lot of pandemic threats – smallpox, influenza, poliomyelitis.” And the road to normalcy from the current pandemic, or any pandemic, is likely to be open only once there is a vaccine.
LONDON – DNA Electronics Ltd. (DNAe) won a U.S. FDA breakthrough device designation for its semiconductor-based DNA sequencing technology Lidia-seq and for the first assay based on the platform, which will detect bloodstream infections and antimicrobial resistance (AMR) genes at point of care.
Specific therapies against a new disease take time to develop. But there are methods that can speed up that development – and in the meantime, there are ways to make do with what’s already in the cupboard.
There will be lessons learned aplenty when the COVID-19 pandemic finally breaks, including how serological and molecular testing can be used to maximum effect to corral a future pandemic. Carmen Wiley, president of the American Association of Clinical Chemistry, told BioWorld that the existing instrument types are up to the job, but that surge capacity is needed, and that it is not clear how the cost of that capacity will be handled.
“In any crisis, leaders have two equally important responsibilities: solve the immediate problem and keep it from happening again... The first point is more pressing, but the second has crucial long-term consequences.” So wrote Bill Gates in a February editorial in The New England Journal of Medicine about COVID-19, which “has started behaving a lot like the once-in-a-century pathogen we’ve been worried about.”