Hightide22 wrote: From the CEO Lexy911 Great interview with David Regan CEO David Regan was downplaying the news and indicated in an interview Friday that the decision by the Food and Drug Administration wasn’t totally unexpected.Wasn't he tweeting that approval could be any day, or 2 days/2 weeks etc. now the decision wasn't unexpected..!! A developer of rapid, point-of-care diagnostic tests, Sona was informed by the FDA on Thursday that the company’s request for emergency use authorization for the marketing of its rapid COVID-19 antigen test in the United States “is not a priority,” which meant such authorization was not issued. Regan told me the FDA had recently updated the template for rapid antigen test applications, “and while we submitted (an application) some time ago . . . under their prior template, (the FDA) updated their template which put greater emphasis on the ability to distribute and manufacture. So, we figure that had a big bearing (on the decision).” Although Sona indicated the FDA decision did not comment on the performance of its test, Regan said he figures the fact that Sona is a small foreign company and not a large U.S. firm with significant capacity to manufacture and distribute tests was also a factor. Now, rather than focusing on the market of 360 million people in the United States, he said, Sona will be satisfied to concentrate on the Canadian market of 36 million people, “which is certainly a better match in terms of our ability to service demand.” Oh so now they don't have the ability to produce millions or billions of tests like the pumpers and management led many to believe would be possible..! Regan said Sona has limited manufacturing at its facilities in Dartmouth but the company has a contractor in England ramping up to begin making the antigen tests once Sona has been given permission to take it to market. But Health Canada has not yet approved the rapid COVID-19 antigen test, although the company has received additional questions on its application. Also, Health Canada has submitted the company’s tests to the Public Health Agency of Canada’s National Microbiology Laboratory for evaluation, which is ongoing. “We’re engaged with Health Canada, they’re working hard on it, we’re working hard on it,” Regan said. “You know, one of the challenges is (determining) the best use of these rapid tests, particularly in Nova Scotia, where we don’t have a backlog for (polymerase chain reaction) testing.” The best use for Sona’s 15-minute rapid antigen test would be at a single location, such as a nursing home, he said. The test would provide almost instant feedback on staff, visitors or residents who may have come in contact with the COVID-19 virus. The goal of the Sona product is not to be used in a doctor’s office to make a diagnosis, Regan said. “This is perfect for screening.” The company’s antigen test has been described as being a pregnancy-type lateral flow test that is easy to administer and interpret by non-experts without the need for either laboratory equipment or a device to read its results. Sona has large employers looking for a quick way to screen their workers to determine if anyone has been exposed to COVID-19, Regan said. If the antigen test indicates someone is positive, then they could go to a doctor for confirmation. “Our best use for this rapid test . . . is more for reopening the economy rather than a medical system device,” Regan said. “The challenge is it can only be sold if you get Health Canada approval.” At Health Canada, the only certification category for COVID-19 testing is for a medical diagnostic point-of-care device, he said. “And so it’s held to a very high threshold and yet everyone knows it’s not going to be used for that.” The company has reported that its antigen test showed 85 per cent agreement to polymerase chain reaction results in patients in an in-field study of 99 patients, and 96 per cent sensitivity in laboratory studies. The Sona lab in Dartmouth is steadily working on improving the tests using the company’s proprietary, patent-pending, gold-nanorod technology, he said. The next generation of test will use saliva samples but, Regan said, saliva tests will require a strong and large trial base before getting approval from health authorities. Sona is engaged in talks with several high-profile study groups about a trial of the saliva test, he said. And I said they will have to submit stronger evidence/trials that the saliva test would be allowed to be sold.. and I was attacked by many saying they only need to change the instruction insert.. looks like Moe was right again.. and the pumpers were full of $hit..!! Source: https://www.saltwire.com/business/local-business/roger-taylor-dartmouths-sona-nanotech-continues-on-despite-fda-rebuff-515479/