Therma Bright Inc (TSX-V:THRM, OTC:TBRIF) said it has signed an agreement with a contract manufacturer to produce a weekly minimum of 500,000 AcuVid COVID-19 Rapid Antigen Saliva tests in order to meet the new US Food and Drug Administration's (FDA) Emergency Use Authorization (EUA) guidance on production of diagnostic tests (molecular and antigen) for point-of-care (POC) and at-home use.
The company noted that the contract manufacturer is a European ISO 13845 certified company with deep expertise in diagnostic tests manufacturing and worldwide distribution.
“We're excited to add a new manufacturing partner to our Therma Bright team; one who alone can help us meet the minimum 500,000 weekly production requirement per the November 15, 2021 FDA guidance for COVID-19 antigen diagnostic tests developers,” Therma Bright CEO Rob Fia said in a statement.
READ: Therma Bright to begin US clinical performance study of its AcuVid COVID-19 Rapid Antigen Saliva Test
“We have provided the FDA with the new manufacturing agreement to comply with their latest guidance around production, as we await the final results from our US clinical performance study being conducted at three COVID-19 testing clinics,” Fia added.
As well, Therma Bright noted that, in addition to the new manufacturing partner, it has already secured other manufacturers in three markets - Southeast Asia, Mexico and Canada - to produce more than 500,000 AcuVid tests per month.
The company said that total production capacity from all four manufacturing partners now represents a production capacity of a minimum of 2.5 million AcuVid tests per month.
Therma Bright is a progressive medical diagnostic and device technology company focused on providing consumers and medical professionals with innovative solutions that address important medical and healthcare challenges.
The company also received a Class II medical device status from the FDA for its platform technology that is indicated for the relief of the pain, itch, and inflammation of a variety of insect bites or stings.
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