May 12, 2020 – Halifax, Canada – Sona Nanotech Inc. (CSE: SONA), (OTCQB: SNANF) (the “Company”) is pleased to provide the following update on the development of its rapid-response, Covid-19 antigen test. The Company received confirmation from an independent laboratory that its test achieved a positive response to a recombinant whole spike protein control reagent specific to SARS-CoV2 and matched the limit of detection (LOD) achieved in its own labs. In-house analytical testing has indicated a very high level of specificity to COVID-19, with no false positives being generated.
Further testing will be conducted both in-house and independently using pre-treated viral samples after recent independent testing using virus samples that were de-activated by heat did not provide a response. Exposing a virus to high heat levels can modify its characteristics, making the treated virus sample an inappropriate proxy for a live sample. These findings, coupled with previous hospital-based experiments, have suggested that testing using a live viral culture and/or patient sampling will be required for ultimate confirmation of the effectiveness of the Sona test. The Company expects to confirm further third party validation testing, specific to its device needs, in the near future.
The Company has further acted on results generated from testing laboratories regarding the test design, which have been implemented in its laboratory. Ensuring tests work effectively in a clinical lab and patient setting is critical to the ultimate success of any test. In order to conduct sufficient validation testing for submission for use to regulators, Sona is moving to test its devices with live virus culture and/or patient samples as part of a formal clinical study. Accordingly, the Company is in advanced discussions for arrangements with a leading U.S. laboratory to provide the independent clinical trial data. This verification and validation work is expected to be conducted through the month of May.
The Company continues to work with regulators in anticipation of finalizing a submission to Health Canada for approval and making its formal submission to the FDA for the granting of an emergency use authorization (EUA). Once approved by regulators, the Company expects to begin accepting deposits for sales and commence manufacturing,
As many countries prepare for a re-opening of their economies, there is growing consensus that an increase in testing will be required to keep economies open while still protecting the population. Sona’s rapid Covid-19 antigen test is a device designed to be used at point-of-care to detect the presence of the SARS-Cov2 virus in a patient within 10-15 minutes which could make it a critical component of testing protocols being considered by governments as they devise plans to relax social distancing measures. The Company’s test will not require either specialized equipment or lab based professionals to interpret its test results.
Sona Nanotech Inc.
About Sona Nanotech Inc.
Sona Nanotech Inc. is a nanotechnology life sciences firm that has developed multiple proprietary methods for the manufacture of various types of gold nanoparticles. 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.
Sona’s gold nanorod particles are CTAB (cetyltrimethylammonium) free, eliminating the toxicity risks associated with the use of other gold nanorod technologies in medical applications. It is expected that Sona’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.
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.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION: This press release includes certain “forward-looking statements” under applicable Canadian securities legislation. 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. 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. Accordingly, readers should not place undue reliance on forward-looking statements. 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.