Pandora wrote:
Sona receives further feedback from Health Canada
2020-11-30 12:22 ET - News Release
Mr. David Regan reports
SONA NANOTECH PROVIDES CORPORATE UPDATE
Sona Nanotech Inc. has received further feedback from Health Canada, subsequent to its withdrawal of its application for an interim order authorization (IO) for the marketing of its rapid COVID-19 antigen test. As part of its review, Health Canada commissioned an evaluation from the National Microbiology Laboratory (NML) whose evaluation produced discordant results to the Company's prior analytical and clinical studies conducted by MRIGlobal and SaudiVax.
The Company intends to obtain additional data and use it to augment its submission with the FDA and potentially for a resubmission to Health Canada. The Company will also use its existing data to support a CE Mark application in Europe and to augment its submission for regulatory approval from the SaudiFDA. The Company is also accelerating the validation of its COVID-19 saliva-based test through analytical experiments and is seeking a near-term clinical validation study, as discussed below.
Prior to the Company's regulatory submission in August, no guidelines existed on performance criteria or clinical data requirements for rapid antigen tests in Canada. In evaluating Sona's test, the NML followed a uniform evaluation process for both rapid antigen tests that detect the nucleocapsid and those, like Sona's, that detect spike proteins. The Company had several fundamental concerns with respect to the generic evaluation process followed that did not take into account the unique characteristics of the Sona test. Based on Health Canada's responses to the Company's concerns about the evaluation process, the Company considered a withdrawal from the process to be in the best interest of the business in order to focus on collecting further clinical data.
With a view to reconciling the discordancy, the Company intends to obtain more data on the performance of its test, including more samples from patients within 0-6 days since symptom onset, as requested by Health Canada. While the test showed 100% sensitivity with such samples in its SaudiVax Clinical Evaluation Study, only seven such positive samples were obtained in that study of 39 positive samples, as previously disclosed on the Company's website (https://sonanano.com/wp-content/uploads/2020/11/Sona-SaudiVax_Clinical_Evaluation_Whitepaper.pdf).
Future Plans
While the Company looks to close the gap on the discordancy in evaluation results in Canada for its nasal pharyngeal test, and continue efforts with the EU and Saudi regulatory processes, it will accelerate the development of its saliva-based rapid COVID-19 antigen test, as well as its suite of other non-COVID-19 test prototypes, which are all based on its proprietary gold nanorod technology, including its concussion prototype assay. As previously announced, the Company intends to seek a large-scale clinical trial specifically to validate its saliva-based self test for COVID-19.
Company Chief Executive Officer, David Regan, commented, "The development and understanding of rapid antigen tests has been a fluid and dynamic process over the nine months since this pandemic began. Sona Nanotech, leveraging its proprietary gold nanorod technology, has done the extraordinary in developing one of only a handful of such tests. While our regulatory road has not been straight forward, every entity that has evaluated our test has confirmed its ability to detect the COVID-19 virus and it achieved strong results from our in-field trials. We will now seek further study data to provide sufficient substantiation of clinical performance to warrant regulatory approval."
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. 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 Clinical Evaluation Study of 99 patients and 96% sensitivity in laboratory studies.
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.