After receiving feedback from Health Canada (HC) on the results of the HC assessment being discordant with other evaluations received by the Company from third parties and the requirement to provide further specific clinical data, the Company viewed a withdrawal of the application to be in its best interest, until further information is generated. The Company currently intends to produce additional clinical performance data, particularly for subjects who are within 0-6 days from symptom onset, with a view to resubmitting to one or more regulators.
Different experiments on the same diagnostic device can return different results, depending on materials and approaches used. Regarding test performance with clinical samples, with nasopharyngeal swabs, there can be a high degree of variability of results subject to the swabbing procedure, which is why the Company intends to produce further data from a larger, additional study.
The Company has a very clear plan to move the business forward. Securing a CE Mark for its nasopharyngeal test being the first step in a direct sales strategy for Europe. Second, we intend to secure a further clinical study to provide the additional substantiation of the in-field performance of the test to justify possible resubmissions to regulators. Third, we plan to validate the Company’s saliva-based COVID-19 prototype test with further analytical evaluations and seek to secure a large-scale clinical study for self-testing use and possible over-the-counter use. The Company expects these actions to help it position itself to capitalize on the potential to help slow the spread of the virus by commercializing its tests.
The Company believes that, in considering an application for the authorization of a medical diagnostic device, regulators look for, amongst other things, robust and statistically significant clinical data relevant for the intended use case for the test and the intended population. While our first clinical study in Saudi Arabia included 99 subjects, the Company now intends to secure an additional study to provide further data, particularly with samples from patients within the 0-6 days since symptom onset. Secondly, the Company intends to validate our saliva prototype test with further analytical experiments and, with success, secure a large-scale trial to determine its in-field performance parameters.
Thanks to support from contracted Obelis S.A., the Company has been successful in obtaining a CE Mark designation in Europe. CE Marking serves as a declaration from a manufacturer that their product complies with the essential requirements of the relevant European health, safety, and environmental legislation laid out in the different product directives. It is the relevant European regulatory framework for medical devices to ensure conformity with current standards.
Obelis reviewed the Company’s documentation of test development, optimization, analytical and clinical performance, quality systems, commercial manufacturing characteristics, etc., and advised on compliance with current legislation. For more information, please see https://www.obelis.net/blog/what-is-the-ce-marking-process/.
The Company is in the process of completing the technology transfer process for its tests to a European-based contract manufacturer (CMO). Manufacturing capacity and timing will be determined once a CE Mark declaration is made and the Company issues purchase orders to the CMO. The Company has also commenced the technology transfer process with a North American-based CMO to provide additional manufacturing in anticipation of regulatory approvals. These arrangements anticipate the manufacture of either the Company’s nasopharyngeal or saliva-based COVID-19 tests.
Sona is in partnership with SaudiVax, a US-Saudi joint venture in life sciences, which is a manufacturer of halal vaccines & biopharmaceuticals localized in Saudi Arabia. SaudiVax conducted a medical ethics review board approved clinical trial of Sona’s test with 99 subjects in the summer of 2020. The companies are working together to consider the potential for local manufacturing cooperation in Saudi Arabia.
The Company’s local distributor has facilitated an application to the Saudi Food and Drug Authority (SFDA) for approval of its test. SFDA approval is understood to not be contingent on other regulatory approvals. At this time, there is no commitment to timing and there can be no guarantee that regulatory approvals will be granted in Saudi Arabia.
The Company has an obligation to offer its tests for sale to the Government of Canada and certain other entities in Canada on terms no worse than to other commercial customers as a result of its funding of a $4.1m grant to the Company through NGEN: Next Generation Manufacturing Canada.
Like the Company’s nasopharyngeal test, its saliva test involves sample collection, using its unique collection device, mixing of a sample in a running buffer solution/reagent, and evaluation of the reagent through a lateral flow assay device, using properties similar to the rapid pregnancy test.
With its prototype finished, the Company will now conduct the analytical tests necessary to verify the prototype. During this process, we will be engaging with regulators to understand their key considerations for any saliva test applications they receive. Next, we will seek to secure a large-scale clinical trial in North America to determine the in-field performance of the test. With the data from that study, the Company would expect to submit applications to regulators in multiple jurisdictions.
Any trial of an unapproved medical device in Canada requires a sponsor institution, a principal investigator, a study protocol, relevant medical ethics review board (IRB/REB) approval and then Health Canada Investigational Testing Division approval before a study can commence. The Company is currently working with an institution in Canada to secure IRB approval with a view to conducting a large-scale clinical study of the Company’s saliva test for COVID-19.
The Company is seeking at least 30 positive samples from patients within 0-6 days of symptom onset and at least 100 negative samples, with multiple operators conducting testing, based on feedback received from regulators. The number of trial subjects required will depend on the prevalence of the virus in the area in which the study is conducted.
The Company expects demand for rapid antigen detection tests to continue as long as the virus continues to circulate globally.
With growing rates of infection in many countries and only a handful of rapid COVID-19 antigen tests approved, the Company expects strong demand to continue. Based on conversations with potential customers in multiple jurisdictions, the Company understands that many still have not been able to secure rapid antigen detection tests and would be interested in considering purchasing the Company’s test once relevant regulatory approvals are secured.
The Company is using a direct sales team to focus on sales of its nasopharyngeal COVID-19 test to high-value potential customers whose businesses rely on either their workers or customers operating in close proximity. The Company is also working with distributors in selected territories to extend its reach to potential customers. For the Company’s saliva self-test, it may consider broader distribution agreements.
Sona intends to use the net proceeds of its recent financing to produce further clinical trial data for its rapid COVID-19 antigen nasopharyngeal test, pursue a European regulatory self-certification CE Mark declaration, and pursue further development and clinical trial validation work for its saliva-based version of the test, as well as for general working capital purposes.
The recent mutation relates to a change in the gene sequence of a section of the S2 protein called the Receptor Binding Domain (RBD), which is responsible for the virus’s ability to enter cells. The Sona test identifies the presence of spike proteins in a sample through the S1 region of the spike protein, therefore, the mutation is not likely to have an effect on Sona’s test’s ability to detect the presence of spike proteins in a patient sample.