Mr. David Regan reports
SONA NANOTECH WITHDRAWS RAPID COVID-19 ANTIGEN TEST APPLICATION BASED ON FEEDBACK FROM HEALTH CANADA
Sona Nanotech Inc. withdrew its application for an interim order authorization from Health Canada for the marketing of its rapid COVID-19 antigen test in order to obtain more clinical data to augment its submission. The company is committed to working with regulators to provide additional information and analysis on its test, and to resubmitting its application as quickly as possible.
In addition to continuing to pursue approval of the company's rapid COVID-19 antigen test, which uses a nasal pharyngeal swab, the company continues to validate its saliva sample-based version of the test. The company intends to seek a large-scale trial specifically for its saliva-based test.
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 per cent agreement to RT-PCR results in patients in an in-field study of 99 patients and 96 per cent sensitivity in laboratory studies.
Company president and chief scientific officer Darren Rowles commented: "We have confidence in our rapid COVID-19 antigen test and its ability to detect the virus, especially within the first week of symptom onset. The regulatory approval path for antigen tests is new with evolving guidelines and Sona's test is unique, creating a challenging environment for test developers and regulators alike. We are, however, committed to obtaining the data needed to successfully achieve authorizations."
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 at this time.
About Sona Nanotech Inc.
Sona Nanotech is a nanotechnology life sciences firm that has developed multiple proprietary methods for the manufacture of various types of gold nanoparticles. The principal business carried out and intended to be continued by Sona is the development and application of its proprietary technologies for use in multiplex diagnostic testing platforms that will improve performance over existing tests in the market. Sona Nanotech's gold nanorod particles are CTAB (cetyltrimethylammonium) free, eliminating the toxicity risks associated with the use of other gold nanorod technologies in medical applications. It is expected that Sona Nanotech's gold nanotechnologies may be adapted for use in applications, as a safe and effective delivery system for multiple medical treatments, pending the approval of various regulatory boards including Health Canada and the Food and Drug Administration.
We seek Safe Harbor.
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