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 Week
Toronto, 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,” expressed Rob Fia, CEO of Therma Bright. “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 U.S. clinical performance study being conducted at three Covid-19 testing clinics.”
Since July 2021, the Company has been actively engaged with FDA executives, doctors and scientists on it AcuVid™ COVID-19 Rapid Antigen Saliva Test application. Furthermore, Therma Bright has quickly complied with all new EUA guidance from the FDA, including the September 23, 2021 guidance2 on testing Covid-19 mutations and variants, and now the November 15, 2021 guidance on production capabilities of a minimum of 500,000 tests per week.
Therma Bright is not making any express or implied claims that its test product has the ability to eliminate or cure COVID-19 or the SARS-CoV-2 virus.
Source:
1 Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised): Guidance for Developers and Food and Drug Administration Staff. https://www.fda.gov/media/135659/download
2 Establishing additional Conditions of Authorization for the EUAs of Certain Molecular, Antigen and Serology IVDs related to viral mutations. https://www.fda.gov/media/152406/download
For further information, please contact:
Therma Bright Inc.
Rob Fia, CEO
rfia@thermabright.com
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FORWARD-LOOKING STATEMENTS
Certain statements in this news release constitute “forward-looking” statements. These statements relate to future events such as development and commercialization of a rapid COVID-19 viral assay and related instrumentation, regulatory applications and manufacturing scale up as described in the news release. All such statements involve substantial known and unknown risks, uncertainties and other factors which may cause the actual results to vary from those expressed or implied by such forward-looking statements. Forward-looking statements involve significant risks and uncertainties, they should not be read as guarantees of future performance or results, and they will not necessarily be accurate indications of whether or not such results will be achieved. Actual results could differ materially from those anticipated due to a number of factors and risks. Although the forward-looking statements contained in this news release are based upon what management of the Company believes are reasonable assumptions on the date of this news release, the Company cannot assure investors that actual results will be consistent with these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof and the Company 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 under applicable securities regulations.
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