Under the terms of the agreement, Sona licenses the intellectual property for its rapid saliva COVID-19 test and ASI undertakes to secure an FDA Emergency Use Authorization ('EUA') for point-of-care and at-home use for the test and any necessary associated activities, including medical ethics review board approval, the coordination and underwriting of US-based clinical and any other studies, and FDA EUA application submissions and follow-up. If an FDA EUA is granted, Arlington will coordinate manufacturing and distribution of the test in the
Over the past few months, the Company undertook a thorough analysis and optimization work for its rapid saliva COVID-19 test which resulted in modifications being made to its design. A preliminary evaluation of the resulting test, run by Arlington, compared thirty-seven live viral samples from patients that had generated a positive result with a BinaxNow COVID-19 rapid antigen test. Of the thirty-seven samples tested, thirty-four generated a positive result on both tests. Further testing in an independent lab using PCR confirmed frozen positive samples with CT cut-off of 30 cycles and frozen, pre-COVID-19 negative samples, generated 93% sensitivity (14/15) and 100% specificity (30/30). Further evaluation against PCR test-confirmed COVID-19 positive samples will be required for any regulatory submission or declaration.
Under the terms of the licensing agreement which was signed today, Sona provides ASI with a license to the test technology, its documentation and ancillary support, as well as providing key biological materials for the test at its cost. ASI is responsible for securing an FDA EUA and all associated data required as outlined in the FDA EUA templates or requested by the FDA during the review and approval process. If ASI secures an FDA EUA for the test within six months, ASI will be permitted to manufacture and distribute the test in the US exclusively, subject to certain conditions, and will pay Sona a set percentage of profits from its test sales under a formula that accounts for certain costs of goods sold from each party. Further, ASI will receive from Sona a set percentage of its profits of other sales not facilitated by ASI. The agreement has a term of five years, after which it is annually renewable by mutual agreement of the Parties, and provides both parties with customary audit rights.
Sona's CEO,
Arlington Scientific CEO,
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. Regulatory approvals for the product will be required before sales may be permitted.
Contact:
Tel: 1 604 684 6730
Email: arlen@kincommunications.com
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CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION
This press release includes certain 'forward-looking statements' under applicable Canadian securities legislation, including statements regarding Sona and ASI's plans to develop and pursue regulatory approval for rapid tests for COVID-19. 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, including the risk that the test does not perform sufficiently well in a clinical trial or other studies to warrant regulatory submission or declaration, or if submitted to regulators, that the test would be granted required regulatory approvals. 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.
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