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As part of LumiraDx’s Fast Lab Solutions, the test enables laboratories to increase throughput of their existing open channel PCR systems to more than 250 tests per hour London, UK- June 30, 2021 – LumiraDx announced today that it has achieved CE Marking for LumiraDx RNA STAR Complete SARS-CoV-2. The test, which was initially granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) in October of 2020 and re-issued in March 2021, is a rapid, nucleic acid amplification method for high sensitivity, high throughput COVID-19 testing. With improved performance claims and access to additional open channel…

MIT researchers have found a new angle: applying AI to detect COVID-19 in an asymptomatic patient. From a cough. Recorded by a phone. Earlier this year, researchers from MIT solicited tens of thousands of recorded “forced” (i.e. not naturally occurring) coughs from over 5,300 subjects – both COVID-positive and COVID-negative – in addition to data about physical symptoms and demographics. They then used that data to train a revised version of their Alzheimer’s model (That had been the target of earlier research with this technology) to distinguish between COVID-infected and COVID-uninfected coughers. MIT researchers had been working on AI cough…

Biobot Analytics tracks the spread of Covid-19 by analyzing the wastewater of a given population, and this method is cheaper than individual testing while offering earlier warnings and better trend analysis.  Biobot Analytics is a Cambridge-based wastewater analysis company with strong links to MIT. With its patented technology, Biobot takes a unique approach to Covid-19 testing. By analyzing wastewater samples, this company can detect spikes in Covid-19 cases before individuals have displayed any symptoms. This approach is cheaper than individual mass testing, and it also offers earlier warnings and superior trend analysis.  Founded by students at MIT, Biobot Analytics was…

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…

 A new SARS-CoV-2-specific serology assay, using a rapid gel agglutination assay, has been designed and analysis shows that the tests can provide serological results for SARS-CoV-2 infection within 30 min, using an approach consistent with blood typing assays used routinely in hospital labs around the world. While large-scale efforts are underway to develop vaccines and antiviral therapies,  the rapid development and deployment of diagnostic tests is of key importance. As we learn more about the immune response to SARS-CoV-2, recent reports suggest that IgG and IgM antibodies are produced either sequentially or simultaneously, with concentrations reaching a plateau 6 days…

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