Update NEWS out Halifax, Nova Scotia--(Newsfile Corp. - May 12, 2020) - 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.