[mepr-show rules=”18700″ unauth=”message”] Overview: Founded in 2013, Wells Bio, Inc. is a Korean firm which develops and manufactures in vitro diagnostic tests based on immunochemical, biochemical, and molecular technology. Test Name: CareUS™ COVID-19 IgM/IgG Testing Type: Qualitative rapid diagnostic antibody test Technology: The careUS™ COVID-19 IgM/IgG is an in vitro rapid immunochromatographic diagnostic test using colloidal gold for the qualitative detection of IgM/IgG antibodies against SARS-CoV-2 directly from human whole blood, serum or plasma. Storage temperature needs to be 1-30 degrees Celsius. Test Sample Type: 10 micro liter human whole blood, serum or plasma Time to Result: 10-15 minutes Testing…
Browsing: Diagnostics Tech
Information on the 7 companies selected thus from the NIH Shark tank competition which is offering $250 million in funding for companies that have prospects of developing rapid tests by the Autumn of 2020. After scrutinizing several dozen submissions the National Institutes of Health has selected its first seven projects that will move on to a new phase of manufacturing and scale-up. Nearly nearly a quarter of a billion dollars is available to these firms to scale. The NIH’s Rapid Acceleration of Diagnostics initiative, or RADx, was launched in late April, 2020 with the goal of providing millions of new…
Researchers are working on a testing system that would require a simple exhaled breath. Such a test would serve as an alternative to current tests that are expensive, can take a long time to get results, and require specialized personnel to do the sampling and to analyze the results. According to the scientist leading this work, “Breath analysis is not really a technique that is used widely in the medical field yet, so it is considered early-stage work. We have developed a sensor device that detects nitric oxide and VOCs (volatile organic compounds) in breath and can be used to…
A Covid-19 test that processes saliva samples and does not require special swabs or collection devices received emergency-use authorization by the U.S. Food and Drug Administration on Saturday. SalivaDirect test is expected to be priced at $10 per sample. Cheap, fast saliva-based test could boost testing frequency. Research for the test was done by Yale University’s School of Public Health and was partly funded by the National Basketball Association and the union representing NBA players. The rapid detection test, known as SalivaDirect, “is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” FDA Commissioner Stephen…
Mologic has announced that, following successful independent validation by the Liverpool School of Tropical Medicine (LSTM) and St George’s, University of London, its professional-use rapid diagnostic test for COVID-19 has received a CE mark (meeting European Economic Area standards) and is ready for manufacture and global distribution. Rigorous independent assessment has shown the tests to have a sensitivity of up to 96% (21-28 days post-symptom onset), and specificity of 98.8% (95% CI 96.6-99.8). The test has been validated to date on 108 positive samples, 255 negative samples, and 223 cross-reacting samples in line with the WHO pre-qualification requirements. As with…
Fluxergy is collaborating with Mass General Brigham (MGB) to evaluate Fluxergy’s research-use-only COVID-19 molecular-testing platform. Fluxergy will work with the MGB Center for COVID Innovation, which was launched in late March. The so-called Diagnostic Accelerator is a collaboration between the Wyss Institute and Brigham and Women’s Hospital that aims to speed up the commercialization of innovative diagnostic tests. Fluxergy’s diagnostic system comprises consumable “lab-on-chip” test cartridges called Fluxergy Cards, the Fluxergy Analyzer and FluxergyWorks software. It can provide results in under an hour, and is designed to be cost-effective and scalable, using proprietary printed circuit-board manufacturing and microfluidics technologies. See…
As Reported in Tech Crunch. Everlywell was one of the first startups to announce that it was working on a self-administered, at-home COVID-19 diagnostic kit, but it initially sought out to ship kits before regulators made clear that this was not in line with its guidelines. Everlywell then became intent on working with the FDA to secure a proper Emergency Use Authorization for its kits before sending any to consumers, and that approach has paid off with the U.S. drug regulator issuing an EUA for Everlywell’s tech today. Everlywell‘s COVID-19 Test Home Collection Kit is the first standalone sample collection…
Sanofi and Luminostics to develop COVID-19 smartphone-based self-testing solution Sanofi and Luminostics to join forces on developing breakthrough COVID-19 smartphone-based self-testing solution using Luminostics’ innovative technology. a smartphone-based solution that eliminates the current need for healthcare professional administration or laboratory tests. A self-testing could help providemwhether or not they are infected” with respiratory samples in 30 minutes or less. The system involves smartphone’s optics, controlled by an iOS/Android app paired with an inexpensive adapter. It is combination with “glow-in-the-dark” nanochemistry and signal processing artificial intelligence. The diagnostic platform is composed of: an iOS/Android app to instruct a user on how…