Therma Bright Inc. says Covisafe will fill the gap for existing COVID-19 screening methods, i.e., PCR and Antibody testing.

TORONTO – The Toronto Stock Exchange (TSX) has accepted documentation supporting a binding letter of intent between Toronto-based Therma Bright Inc. and arm's-length vendor Orpheus Medica Inc. for development of a rapid saliva, COVID-19 test. Therma Bright CEO Rob Fia told BioWorld he initially explored the idea of setting up shop at Orpheus’s Toronto plant for the manufacture of PPE but then proposed another idea to Orpheus president and CEO Saeid Babaei.

“I told Saeid we’re in the medical device space and asked him ‘Can we create a diagnostic test for COVID?’ This would be cool because they have a lot of background with rapid testing and are a very knowledgeable group. We really pushed to get something done.”

Let’s not over think this

The underlying premise for any vaccine likely to help treat viral pandemics like COVID-19 is the existence of antibodies produced by the human body and that protect the patient from further infection and illness. Sound simple? It is, said Babaei.

That’s why he’s puzzled by the complex device platforms companies use to test for a broad range of antibodies but cannot yet test for COVID-19 antibodies specifically. Immuno assays, biosensors, microfluidic chambers are “fancy science projects” unable to deliver consistently high sensitivity to targeted pathogens or provide broad usability among patients.

“Basically, we’re looking for something that is simple, cost effective and sufficiently scalable to meet the global demand,” Babaei told BioWorld. “If we develop something amazing but can only produce a thousand of those it’s not going to be very useful.”

The “something amazing” said Babaei is transfer of what Orpheus learned testing for cannabis use and food pathogen outbreaks to the COVID-19 pandemic. The result is an antibody/peptide-based computational platform that uses machine learning to detect multiple types of antigens, including SARS-CoV-2, the virus that leads to COVID-19.

How to prove that? Upcoming trials that “piggy-back” on to existing clinical trials that monitor viral loads and treatment impacts in patients, Babaei replied. “From this, blood and saliva samples will be tested at bedside,” he explained. “Clinicians will then be able to actually see how our test compares with conventional core laboratory testing.”

Therma Bright’s contribution will be Covisafe, a small, saliva-based device held between the thumb and forefinger very much like a pregnancy test, which will test for COVID-19. In addition to Orpheus’s underlying computational analysis and a sensitivity/specificity rating above 95%, the test will take less than 20 minutes, said Fia.

“I have heard about other saliva-based tests, but you still have to provide a sample that must be sent to a lab. It is not as effective or as quick as what we’re proposing to create here with this product.”

Confidence is key

At stake for Orpheus under phase 1 of the project are 1 million common shares and 1 million share purchase warrants issued by Therma Bright, each warrant representing one common share at 5 cents for a five-year period. Still to come under phases 2 and 3: up to CA$1 million (US$750,000) based on Orpheus attaining predefined milestones.

A key milestone is Therma Bright’s confidence in Orpheus’s proof of concept for its computational platform and a massive library featuring billions of antibodies and peptides from which will be selected a series of antibodies that bind to COVID-19, said Babaei.

“In short, Therma Bright wants to be sure that series of antibodies is COVID-19 friendly, that it is actually able to detect the virus. And because Therma Bright is a public company, it had to embark on a very detailed due diligence process.”

For his part, Fia’s confidence in Orpheus stems from its track record in computational biological analysis and development. PCR-based testing may be widespread, but this involves time consuming blood draws and lab testing, said Fia. “Or there are nasal swabs which are very uncomfortable, but which also require time to process before you can receive a result.”

By contrast, Covisafe is faster, noninvasive and easier to use, said Fia. But it’s what sits underneath that really counts: a novel biologics platform he called “nothing less than revolutionary.”