Therma Bright Inc (TSX-V:THRM, OTC:TBRIF, FRA:JNX)., a medical device technology company that recently filed its application for Emergency Use Authorization (EUA) approval to market its AcuVid Covid-19 Rapid Antigen Saliva Test with the US Food and Drug Administration (FDA), said it continues to “monitor and interact” with the FDA as necessary regarding its “active submission.”
While waiting on the FDA decision, the Toronto, Ontario-based company has ordered sufficient materials and components to manufacture the first batch of AcuVid tests in the US. At the same time, Therma Bright is securing multiple manufacturing sites in different countries to be able to meet the anticipated demand for our test in the US and elsewhere.
Therma Bright said it is identifying and negotiating with potential customers in various jurisdictions to secure initial orders pending regulatory approval.
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In a statement, Therma Bright CEO Rob Fia said: "We continue to build manufacturing capacity for our test in anticipation of approval so that we can meet the expected huge demand for rapid testing. Our saliva-based test is easier to use and less intrusive than nasal swab-based tests and is ideally suited for rapid testing for all subjects."
In the update for its AcuVid COVID-19 test, Therma Bright said that it is currently identifying sites to perform trials on the AcuVid test for home use applications. “The results from these trials will be used to file for approval to market the AcuVid Covid-19 Rapid Antigen Saliva Test for home use by non-healthcare professionals,” said the company. This should “greatly expand” the market for test, it added.
Once a site is identified, Therma said it will report back to shareholders on the expected date to complete the home use clinical study.
In September 2021, the Centers for Disease Control and Prevention (CDC) stated that they expect shortages of rapid tests as demand increases. The CDC, and other bodies, recommend serial testing using rapid antigen tests at least once per week, along with other mitigation measures, such as masking and social distancing, to reduce disease transmission, especially in crowded settings such as offices, factories, schools, and large events.
Therma Bright’s initial breakthrough technology delivers effective, non-invasive, and pain-free skincare. The company received a Class II medical device status from the FDA in 1997 for its platform technology that is used for the treating the pain, itch, and inflammation from insect bites or stings
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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