Bullboard - Stock Discussion Forum Therma Bright Inc V.THRM

Alternate Symbol(s): TBRIF

Healthcare Medical Devices

Therma Bright Inc. is a Canada-based company, which is a developer and partner in a range of diagnostic and medical device technologies. It focuses on providing consumers and medical professionals with solutions that address medical and healthcare challenges. It is involved in developing, acquiring, manufacturing, and marketing proprietary healthcare and medical devices for the consumer and... see more

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TSXV:THRM - Post Discussion

Therma Bright Inc > Benchmark to Acuvid- PCL's COVID19 Antigen (Saliva) Ag Test

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Post by Watchman21 on Aug 17, 2022 3:32pm

Benchmark to Acuvid- PCL's COVID19 Antigen (Saliva) Ag Test

Last post of today….

Market research on like products to Acuvid COVID19 Rapid Antigen Saliva Test for Point of Care (THRM's first submission for FDA EUA and HC io#3). Health Canada Interim Order #3 Authorization for PCL SELF TEST-COVID19 Saliva Ag Test was granted on May 5, 2022. So now Health Canada has a benchmark to evaluate all other Covid-19 rapid antigen SALIVA tests against their minimums including +80% PPA and +96% NPA.

Here’s PCL’s Information For Use (IFU) with “Canada” in the file name. It’s very similar to the HC io#3 IFU’s for the other 48 Covid-19 Rapid Antigen Nasal Tests that have been authorized. Its just saliva with a few more tests around mouth-borne viruses. Furthermore, this IFU is very similar to US FDA EUA IFUs for the 51 COVID-19 Rapid Antigen Nasal Tests, again with the added mouth-borne cross reactivity data (not included in these nasal tests)

All in all, this IFU for the first HC IO#3 authorized saliva test provides insight to PCL’s performance for it Clinical Study, Cross Reactivity Studies for Mouth- and Nasal-Borne Viruses & Bacteria, and other Interference items like toothpaste, mouthwash and nasal spray. All this research data in prominently featured is PCL’s Covid-19 Rapid Antigen Saliva Test for Self Care IFU. This same information is also used in PCL’s Covid-19 Rapid Antigen Saliva Test for Point of Care IFU, which was granted on April 8, 2022. One difference is PCL’s Point of Care test was approved for both nasal and saliva, so the PoC IFU includes some nasal research data.

PCL SELF TEST-COVID19 (Saliva) Ag Test https://rapidtestandtrace.ca/wp-content/uploads/2022/05/IFU_COV04ST_PCL_Canada-1T-2T-3T-5T-25T-50T12.pdf

This is just 1 industry benchmark item I have used to consider THRM’s Acuvid ability to secure Health Canada IO#3 Authorization. Plus, since I believe THRM’s Acuvid tests has been through the ringer and far more testing than PCL, including several rounds of FDA reviews and requests, I believe there is a strong case for securing FDA EUA as well. Again, just sharing some additional information. Do what you feel is right for your investment. It's your money, so take responsibility. I'll be responsible for my money, thank you!

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