Press Release, April 13, 2020;
Sona Nanotech Provides a Progress Update on its Covid-19 Antigen Test
Sona Nanotech Inc. is pleased to provide an update on the development, manufacturing arrangements and pre-orders for its Covid-19 antigen test. The Company this past week has:
Progressed from feasibility and prototype testing to the optimization stage for its Covid-19 antigen rapid response test;
Commenced work with two, third-party laboratories to prepare validation protocols;
Signed a memorandum of understanding to manufacture its test with a second contract manufacturer in North America;
Accepted pre-orders for a further 1,250,000 of the Company’s antigen detecting, rapid-response test; and
The Company continues to advance the performance of its Covid-19 antigen test. This past week, the Company tested a working prototype in a hospital laboratory environment with live, Covid-19 patient samples, achieving positive results. Accordingly, Sona’s prototype test progressed to the optimization stage during which work will be done to ensure it attains maximum performance in both quality and accuracy.
“Development work on our test is largely complete and we have moved to an optimization stage utilizing a third party for the optimization process. In recent weeks, many antibody detecting tests have entered the market generating concerns over performance and applicability. These serological tests detect IgG and IgM antibodies which are not necessarily unique to the SARS-CoV-2 virus and should not be used as a predictor for immunity against Covid-19. Sona is therefore dedicated to getting an antigen test in the field as quickly as possible, but not at the expense of accuracy or quality,” stated Darren Rowles, CEO Sona Nanotech.
“Considering that neither the virus antigen nor specific virus antibodies existed until recently, we are extremely pleased with where the Company’s rapid, point-of-care test now stands,” added independent director, Dr. Michael Gross, MD, FRCSC. The Company has begun to work with independent third party test validators to help direct test optimization and to identify key test performance factors. The Company’s optimisation protocols involve maximizing test sensitivity and specificity, while mitigating for cross-reactivity and interference. The Company cautions that its Covid-19 test is still in development and will provide updates as appropriate.
The Company also completed its second manufacturing MOU arrangement for its point-of-care, Covid-19 antigen test. The agreement with a North American based manufacturer will simplify the supply chain and provide added capacity to the existing agreement with its European based supplier. Ongoing discussions with other manufacturers will continue to ensure that additional manufacturing capacity is available. Under the previously announced arrangement with its European manufacturer, the Company has made an initial milestone payment towards the set-up and transfer of its test technology for test kit manufacturing.
All pre-orders received to date are in the form of letters of intent for the purchase of the Company’s Covid-19 antigen rapid tests, following the validation of the test at which point deposits will be due to the Company. The Company currently has pre-orders for over 3 Million (3,000,000) test kits.
Finally, development of the Company’s product portfolio of other proprietary lateral flow tests will continue upon completion and commercialization of the Company’s Covid-19 antigen test. These other tests leverage the Company’s proprietary gold nanorod technology’s highly sensitive ability to detect various biomarkers in the Pico gram range.
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