Trading at just 12 cents per share at the beginning of the year, shares in Sona shot up to more than 15 dollars apiece by July as the pandemic pushed investors towards hyped healthtech stocks. In terms of the Canadian market, Health Canada is reportedly continuing with its evaluation of Sona’s application for an interim order authorization, with further follow up conducted by the agency just yesterday. The company’s antigen test is currently being assessed by the U.S. Food and Drug Administration’s, but has been refused an emergency use authorisation, which would have seen it fast tracked through the regulatory process. The regulatory approval path for antigen tests is new with evolving guidelines and Sona's test is unique, creating a challenging environment for test developers and regulators alike. Sona disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. While this doesn’t spell great news for the company’s hopes south of the border, Sona’s application with Health Canada remains ongoing. You may watch a recording above. Sona Nanotech Withdraws Rapid COVID-19 Antigen Test Application Based on Feedback from Health Canada. Theratechnologies (TH) has revealed new findings for its lead investigational compound, which could now help treat several additional cancers. Sona’s unique gold nanotechnology is very impressive and has the potential to transform lateral flow. In addition to continuing to pursue approval of the Company's rapid COVID-19 antigen test, which uses a nasal pharyngeal swab, the Company continues to validate its saliva sample-based version of the test. Skittish investors are abandoning shares in Sona Nanotech (SONA) today, after its COVID-19 antigen test application was downgraded by the US FDA. The Company is committed to working with regulators to provide additional information and analysis on its test and to re-submitting its application as quickly as possible. It must be noted however that the FDA ruling does not reflect the test's performance, simply the US health authority’s ruling on the urgency of its application. The FDA cited current EUA request prioritization criteria as including "the public health need for the product" and did not comment on the performance of the Sona test. We are, however, committed to obtaining the data needed to successfully achieve authorizations.". Phil Groom. Market Data powered by QuoteMedia. NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN THE POLICIES OF THE CANADIAN SECURITIES EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE. CloudMD’s healthcare education platform, iMD Health Global (iMD), has formed the partnership to provide relevant mental health resources, tools and information into the hands of healthcare providers and their patients. On November 25, 2020, the Company announced its withdrawal of "an Interim Order authorization from Health Canada for the marketing of its rapid, COVID-19 antigen test in … The principal business carried out and intended to be continued by Sona is the development and application of its proprietary technologies for use in multiplex diagnostic testing platforms that will improve performance over existing tests in the market. The Company intends to seek a large-scale trial specifically for its saliva-based test. Sona Nanotech's gold nanorod particles are CTAB (cetyltrimethylammonium) free, eliminating the toxicity risks associated with the use of other gold nanorod technologies in medical applications. CAPE TOWN - President Cyril Ramaphosa is set to deliver the State of the Nation Address (Sona) on Thursday. COVID-19 plays have been abound and in our discussions since as early as December of 2019.SONA Nanotech is a Canadian nanotechnology company that has mostly been under the radar hitting a low of 0.10 CAD in December of 2019 but with the appointing of a new interim CEO and the focus of their technology being placed into a lateral flow test kit for COVID-19 they have recently hit a high of … "There was a moment of tremendous pride for the entire team, as … Halifax, Nova Scotia--(Newsfile Corp. - November 25, 2020) - Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company"), a developer of rapid, point-of-care diagnostic tests, withdrew its application for an Interim Order authorization ("IO") from Health Canada for the marketing of its rapid, COVID-19 antigen test in order to obtain more clinical data to augment its submission. It ensures that high-quality health services are accessible, and works to reduce health risks. On November 25, 2020, the Company announced its withdrawal of “an Interim Order authorization from Health Canada for the marketing of its rapid, COVID-19 antigen test in … Health Canada continues its evaluation of the Company's application for an Interim Order ("IO") authorization for its test as a 'point-of-care' medical diagnostic device. The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 virus (or SARS-2 Coronavirus) at this time. Health Canada said the vaccine is for use in people 16 years of age or older, but noted Pfizer-BioNTech are running further clinical trials on children of all age groups and that could change. HALIFAX – Dartmouth’s Sona Nanotech lab is making history by developing a rapid antigen test for COVID-19. Meanwhile, the company’s application with Health Canada remains unaffected and ongoing Sona Nanotech (SONA) is down 50.1 per cent and is trading at C$3.80 per share Skittish investors are abandoning shares in Sona Nanotech (SONA) today, after its COVID-19 antigen test application was downgraded by the US FDA. To view the source version of this press release, please visit https://www.newsfilecorp.com/release/68977, https://www.newsfilecorp.com/release/68977. Company President and Chief Scientific Officer, Darren Rowles, commented, "We have confidence in our rapid COVID-19 antigen test and its ability to detect the virus, especially within the first week of symptom onset. To date, the U.S. Food and Drug Administration (FDA) has approved only four comparative Point of Care tests for COVID-19, while Health Canada has approved one PCR-like test. Pfizer and BioNTech said it will supply a minimum of 20 million doses to Canada through 2021 and as many as 76 million. Underpinned by Sona Nanotech's proprietary, patent-pending, gold nanorod technology, its test showed 85% agreement to RT-PCR results in patients in an in-field study of 99 patients and 96% sensitivity in laboratory studies. SONA has partnered with UK’s BOND Digital Health, required by governments to track and trace the spread of the virus for future monitoring. CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION: This press release includes certain "forward-looking statements" under applicable Canadian securities legislation, including statements regarding Sona's plan to re-submit to Health Canada, the anticipated use of Sona's rapid COVID-19 antigen test by employers as a screening tool, and the development and trails for the saliva test technology. We are a federal institution that is part of the Health portfolio. The performance of the test was apparently not commented on, however the ruling is certainly a setback for the company. “Large companies, employing thousands of people, are telling us that they cannot source rapid antigen tests which they view as critical to their business continuity and for the safety of their employees,” he added. Data delayed 20 minutes unless, Skittish investors are abandoning shares in Sona Nanotech (SONA) today, after its COVID-19 antigen test application was downgraded by the US FDA, The FDA has refused to grant Sona's application an emergency use authorisation, which would have seen it fast tracked through the regulatory process, Nevertheless, the FDA ruling does not reflect the test’s performance, simply the U.S. health authority’s ruling on the urgency of its application, Meanwhile, the company’s application with Health Canada remains unaffected and ongoing, Sona Nanotech (SONA) is down 50.1 per cent and is trading at C$3.80 per share. Despite the news, Sona CEO David Regan remains hopefully and said the demand for these tests in the private sector continues to grow. Its product portfolio includes Gemini 650NM, … Sona Nanotech, Inc. engages in the development and manufacture of rod-shaped gold nanoparticles. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Canada health regulator approves Pfizer’s COVID-19 vaccine Canada is set to receive up to 249,000 doses this month and 4 million doses of the vaccine by … Accordingly, readers should not place undue reliance on forward-looking statements. ... including statements regarding Sona's plan to re-submit to the FDA and Health Canada, and to augment its … “There was a moment of great pride for the whole team, as Canadians, when our assessment results came back from both third-party labs and field trials and it showed how our test went well, ”said CEO David Regan. • Editor's note: This live event has ended. In what is a major blow to shareholders of Sona Nanotech (CSE: SONA), the company this afternoon announced that it has withdrawn its rapid COVID-19 antigen application from Health Canada based on feedback it has received from the regulatory agency.The move is being conducted “in order to obtain more clinical data to augment its submission.” Rising from sale price of 0.20 to $3.80 on June 1, 2020 the stock price increase can be attributed to the anticipation of an influx of test kit orders once approved by Health Canada. It is also cost competitive and produces timelier results, giving investors hope that Sona’s test can become the market standard. To assist with Canada’s response to COVID-19, the Honourable Patty Hajdu, Minister of Health, announced that she has signed an Interim Order to allow expedited access to COVID-19-related medical devices for use by healthcare providers, including diagnostic test kits. Commercial Director, Bond Digital Health We are proud to partner with such an innovative company and we know that together Sona and Bond can achieve great things. The point of care test works somewhat like a pregnancy test: place a nasal sample on a device strip that will show a colour-coded positive or negative result. Investor Relations Contact:Arlen Hansen604 684 6730 | 1 866 684 6730arlen@kincommunications.com, For more information about Sona, please contact:David ReganChief Executive OfficerTelephone: +1.902.536.1932. Health Canada is responsible for helping Canadians maintain and improve their health. Health Canada said the vaccine is for use in people 16 years of age or older, but noted Pfizer and BioNTech are running further clinical trials on children of all age groups and that could change. All rights reserved. Mr. Ford pleaded with Health Canada to approve saliva testing and rapid antigen testing, two advances he said would improve the testing bottleneck in Ontario Sona Nanotech is a nanotechnology life sciences firm that has developed multiple proprietary methods for the manufacture of various types of gold nanoparticles. Victory Square Technologies (VST) has secured manufacturing, sales and distribution agreements for Europe and the United States for its COVID-19 rapid tests. Halifax, Nova Scotia--(Newsfile Corp. - November 25, 2020) - Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company"), a developer of rapid, point-of-care diagnostic tests, withdrew its application for an Interim Order authorization ("IO") from Health Canada for the marketing of its rapid, COVID-19 antigen test in order to obtain more clinical data to augment its submission. Sona Nanotech (SONA) is down 50.1 per cent and is trading at C$3.80 per share at 10:57am EDT. The Mental Health Commission of Canada is funded by Health Canada. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements, including the risk that Sona may not be successful in obtaining regulatory approvals necessary for the best use of its products, that potential customers may not adopt its products for screening uses, that Sona's saliva test technology may not prove to deliver the same level of testing accuracy and sensitivity as its nasal pharyngeal swab-based test, that Sona may not be successful in identifying or reaching agreements with additional manufacturing partners, that Sona's manufacturing partners are not able to scale up manufacturing of Sona's products to the anticipated level, that raw materials may not be available in the amounts or on the schedules required to achieve Sona's manufacturing targets, that Sona may not be able to obtain further clinical data, that Sona may not resubmit to Health Canada and that regulatory requirements may change. However, news of the deprioritization has spooked investors hoping for a windfall of test sales in the U.S., halving the company’s shares price at market open this morning. Canadian telehealth company CloudMD (DOC) has partnered with the Mental Health Commission of Canada. Sona Nanotech Arranges Private Placement Financing and Appoints EU Agent for Application for CE Mark. Sex toy expert Virginia Cerrone reviews LELO’s Sona Cruise vibrator toy that mimics oral sex and explains how it "creates the kind of orgasm every woman should try at least once in her life." Sona Nanotech’s (SONA) previously announced private placement for up to C$2 million in proceeds is now fully subscribed. It is expected that Sona Nanotech's gold nanotechnologies may be adapted for use in applications, as a safe and effective delivery system for multiple medical treatments, pending the approval of various regulatory boards including Health Canada and the FDA. Essentially, the reclassification means Sona’s product is not a priority for the US health authorities, leaving investors worried that the company’s product might fail to live up its dizzyingly high share price. Sona Nanotech's rapid COVID-19 antigen test offers results within 15 minutes, using 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. November 25, 2020 – Halifax, Canada – Sona Nanotech Inc. (CSE: SONA), (OTCQB: SNANF) (the “Company”), a developer of rapid, point-of-care diagnostic tests, withdrew its application for an Interim Order authorization (“IO”) from Health Canada for the marketing of its rapid, COVID-19 antigen test in order to obtain more clinical data to augment its submission. One of these companies is the Halifax-based Sona Nanotech , which developed the COVID-19 Lateral Flow Assay that is currently awaiting Health Canada approval. Twitter; Instagram; LinkedIn; Read. HALIFAX -- The Sona Nanotech lab in Dartmouth, N.S., is making history by developing a rapid antigen test for COVID-19.