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Therma Bright Expands Manufacturing Capabilities To Meet New FDA EUA Guidance For AcuVid(TM)
Agreement with Contract Manufacturer Provides for Production of 500,000 AcuVid(TM) Tests Per W...
About this update from Therma Bright Inc.
[{"type":"text","content":"Therma Bright Expands Manufacturing Capabilities To Meet New FDA EUA Guidance For AcuVid(TM)Agreement with Contract Manufacturer Provides for Production of 500,000 AcuVid(TM) Tests Per WeekToronto, Ontario--(Newsfile Corp. - December 1, 2021) - Therma Bright Inc. (TSXV: THRM) (\"Therma\" or the \"Company\"), developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to announce 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 U.S. Food and Drug Administration's Emergency Use Authorization (EUA) Guidance on production of diagnostic tests (molecular and antigen) for point-of-care (POC) and at-home use. The contract manufacturer is a European ISO 13845 certified company with deep expertise in diagnostic tests manufacturing and worldwide distribution.In response to section IV of the recent Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised): Guidance for Developers and Food and Drug Administration Staff 1 issued on November 15, 2021, the Company entered into an agreement with a contract manufacturing firm with capabilities to deliver a minimum of 500,000 tests per week. Per the new guidance: \"Specifically, at this stage of the pandemic, the FDA intends to focus its review on EUA requests for the following types of tests;Diagnostic tests (molecular and antigen) that can be used at the POC or completely at home, from developers who have indicated the ability to scale up manufacturing capacity to 500,000 tests per week within 3 months of authorization.\"In addition to the new manufacturing partner, Therma Bright has already secured other manufacturers in three markets - Southeast Asia, Mexico and Canada - to produce over 500,000 AcuVid™ tests per month. The Company's total production capacity from all four manufacturing partners now represents a production capacity of a minimum of 2.5 million AcuVid™ tests per month.\"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,\" expresse...