Sona Nanotech Inc C.SONA

Alternate Symbol(s): SNANF

Healthcare Biotechnology

Sona Nanotech Inc. is a nanotechnology life sciences company, which is engaged in developing targeted hyperthermia therapy. The Company has developed multiple methods for the manufacturing of various types of gold nanoparticles (GNR). It is engaged in research and development of its technology for use in multiplex diagnostic testing platforms and advanced biomedical applications. Its gold nanotechnologies are adapted for use in applications, as a safe and delivery system for multiple medical treatments, for the approval of various regulatory boards, including Health Canada and the Food and Drug administration (FDA). Its gold nanorod particles are manufactured without the use of cetyltrimethylammonium bromide (CTAB), eliminating the toxicity risks associated with the use of other gold nanorod technologies in medical applications. The Company is focused on the development of a pre-clinical nanomedical therapy for the treatment of cancer using its biocompatible GNR.

CSE:SONA - Post by User

Sona Nanotech Inc

Bullboard Posts

Post by Aarman4on Aug 06, 2020 6:38pm

280 Views

Post# 31376068

CURRENT SONA situation...August 6th.

This is a long post, my apologies, but should be good for any new(ish) investors to help them cut through the bashing and nonsense being posted around here.......

FYI - According to SONA News Release, we should expect fully completed field testing by August 20th, 2020.

I will post 3 things:

August 6th, 2020 News Release
July 29th, 2020 FDA News release relating to at-home Covid testing template
Link to FDA at-home template

Cheers!

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Sona Nanotech Updates on Timing of Clinical In-Field Validation Studies for its COVID-19 Antigen Test Halifax, Nova Scotia--(Newsfile Corp. - August 6, 2020) - Sona Nanotech Inc. (CSE: SONA), (OTCQB: SNANF) (the "Company"), a developer of rapid, point-of-care diagnostic tests, announces that its previously announced clinical, in-field evaluation studies for its rapid detection, COVID-19 antigen test that commenced in July continue and are now expected to return their full results within two weeks. The delays have been due to ethics review board approvals and a need to make study modifications to accommodate regulatory updates, including for study enrolment criteria and assessment at point of care settings, as well as for test handling procedures. The evaluation protocol for these studies incorporates aspects of the revised guidance released by the FDA on July 29, 2020. The FDA's new template for commercial developers of non-lab COVID-19 tests included updated guidance on performance evaluation studies, comparator methodology, flex studies, human usability studies, and clinical evaluation, amongst other study components. The Company is committed to the robust evaluation of its COVID-19 antigen test and to submitting a comprehensive data set in its submissions to the FDA and Health Canada that adheres to its recommended guidance. For more information on the new FDA guidance, please see: https://www.fda.gov/news-events/pressannouncements/coronavirus-covid-19-update-fda-posts-new-template-home-and-over-counterdiagnostic-tests-use-non The data from these studies will be used to support the Company's analytical and clinical data as part of the submission it will make to Health Canada and the FDA for emergency use authorization ("EUA") approval for its COVID-19 antigen test. In addition to its in-field clinical evaluation studies, the Company has also provided prototype tests to several potential customers, under 'research use only' labelling, with whom it has entered into letters of intent for larger purchases of its tests. These smaller studies are part of the Company's commitment to maintaining ongoing evaluations of its test in order to understand its performance in a wide range use case scenarios. Rapid, point-of-care, antigen tests can make a significant contribution to reducing the spread of COVID19 by detecting the presence of the virus in individuals, potentially before the onset of symptoms. As previously announced, the Company's rapid detection, COVID-19 antigen test's laboratory validation of performance levels resulted in a test sensitivity of 96%, test specificity of 96% and a Limit of Detection ("LOD") of 2.1 x 10 2 TCID 50. One of the purposes of the in-field evaluation testing is to determine, what, if any, effect environmental or containment factors or human errors in sample collection have on test performance. The Company cautions that its COVID-19 rapid antigen test is not yet approved by the FDA or other regulatory bodies and will update the market as appropriate.

Investor Relations Contact: Arlen Hansen 604 684 6730 | 1 866 684 6730 arlen@kincommunications.com

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Diagnostic Tests for Use in Non-Lab Settings, Such as Homes, Offices or Schools

For Immediate Release:: July 29, 2020

Today, the U.S. Food and Drug Administration posted a new template for commercial developers to help them develop and submit emergency use authorization (EUA) requests for COVID-19 diagnostic tests that can be performed entirely at home or in other settings besides a lab, such as offices or schools, and that could be available without a prescription.

“The FDA continues to help facilitate innovation in test development, thereby enhancing Americans’ access to COVID-19 tests,” said FDA Commissioner Stephen M. Hahn, M.D. “The recommendations provided today are intended to help get tests to market that are simple enough to use at home, similar to a pregnancy test. We hope that with the innovation we’ve seen in test development, we could see tests that you could buy at a drug store, swab your nose or collect saliva, run the test, and receive results within minutes at home, once these tests become available. These types of tests will be a game changer in our fight against COVID-19 and will be crucial as the nation looks toward reopening.”

The template includes recommendations for validation when a sample is to be collected and analyzed, and results are to be returned without the need to send a sample to a lab for analysis. The template also gives recommendations for validation of tests that are intended to be made available over-the-counter, that is, without a prescription.

This template outlines the recommended performance for this type of test, including sensitivity and specificity. While the recommended sensitivity for these non-lab tests is lower than lab-based tests, the tremendous benefits of broader access to simple and fast testing options generally outweighs this risk.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Link to template:(Copy/paste)

https://www.fda.gov/media/140615/download