When it comes to quick, on-the-spot COVID-19 testing, Therma Bright Inc. (TSX-V:THRM, OTC:TBRIF) CEO Rob Fia says convenience plays a key role.
Most rapid antigen testing kits now available require users to shove and twirl cotton swabs up both nostrils (at least an inch deep) to obtain the best measuring samples. It can be a cringeworthy, unnatural, and sometimes painful experience, especially for school children.
But Therma Bright has elevated self-administered antigen testing to a whole new level to make the process easier and less invasive by using saliva spit instead of nasal swabs to detect the presence of the COVID-19 disease and its Delta and Omicron variants, which are caused by the SARS-CoV-2 coronavirus.
“It's much more comfortable versus the nasal anterior antigen test. A lot of people complain about that,” said Fia, whose company is poised to roll out its AcuVid COVID-19 Rapid Antigen Saliva Test in the first quarter of 2022 following expected US regulatory approval.
The AcuVid salvia test is not much different than the nasal test, except this time the user simply spits in a collection tube. Then that salvia is mixed with a chemical solution in another tube and the resulting solution is added (4 drops) to the cassette sample port. And exactly like a nasal swab antigen test, the salvia results - positive, negative, or invalid -- show up in 15 to 20 minutes.
“We've been able to get out there and determine where we could price where it's competitive in the marketplace next to nasal,” Fia said. “I think if we can come in close to what they're selling the nasal test for, people will prefer this product over the nasal test.”
Anticipating Emergency Use Authorization after clinical study
Before Therma Bright can bring its point-of-care (POC) test to market in the US, it must win Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). Under agency guidance, the company is currently running a clinical performance study involving up to 300 participants at three US sites comparing their AcuVid results against their RT PCT test results.
During initial trials in Brazil, the test showed an 85% sensitivity rate and 98% specificity rate, which are requirements for EUA approval. But the agency wanted more data, thus prompting the current clinical performance study.
“We're knocking off all of the requirements they're looking for,” he said. “And then hopefully this time around when we submit everything, it should go a lot smoother, a lot quicker.”
However, the Omicron variant and the massive ramp-up of testing have slowed down Therma Bright’s time plans to finish the study.
“With the rapid spread of the Omicron variant, our clinics and their labs have been overwhelmed with a massive wave of COVID-19 RT PCR testing,” he said, noting that more-accurate PCR tests take 48 hours to produce an answer.
“This has caused delays in receiving these lab-based tests for several days, thus slowing down the process in matching each participant's AcuVid COVID-19 Rapid Antigen Saliva Test with their specific RT PCR test.”
Even with the right clinical data, the company also faces another hurdle - production capacity. To win the EUA, Therma Bright must demonstrate it can produce 500,000 tests a week.
In fact, the company stands ready to meet that threshold. It has struck deals with four manufacturers in Canada, Europe, Malaysia, and Mexico and will launch production for the US market once it wins FDA clearance. All told, the total production capacity from its manufacturing partners now translates into a minimum output of 2 million AcuVid tests per month.
Market test to medical facilities and then for home use
The company initially will target medical facilities, pharmacies, nursing homes, and healthcare professionals stationed at schools and government buildings, venues, office buildings, and airports, among other public spaces where lots of people congregate.
After the POC version hits the market, Therma Bright plans to apply for regulatory approval and launch an at-home/on-the-go test that can be purchased online or over the counter at a local grocery or pharmacy.
Fia, who said current data from the study “are very promising,” is optimistic the company will get the green light from the FDA to launch the AcuVid test. Since July 2021, the company has actively engaged with FDA executives, doctors, and scientists on the best ways to meet regulatory compliance.
“We feel pretty good with this next round of submission,” he said. “We've met everything they've asked for. I think we're in good shape. This time they should know the file and it should move quicker.”
Fia noted that there’s pent-up demand for saliva testing, including interest from “some big potential customers” who not only like the product but the company’s production capacity as well.
“That's what we've been working on,” he said. “We can now do large-scale manufacturing with our partners. Nothing would make me happier than getting this approved because I don't think there's any shortage of orders at this stage to get this product out into the market.”
Also advancing its legacy over-the-counter non-evasive products
While Therma Bright eyes impending commercialization for AcuVid, the company is advancing its four legacy over-the-counter non-evasive products that treat chronic pain and skin conditions without drugs.
The company has developed the Benepod hot & cold contrast therapy device, the InterceptCS cold sore prevention system, and the Venowave circulation-booster device to treat blood clots. Its TherOZap device uses thermal therapy to provide relief for the pain, itch, and inflammation caused by more than 20,000 different insect stings and bites.
Looking ahead, Fia said Therma Bright enters 2022 with a strong balance sheet that will allow it to ramp up production, marketing, and commercialization of the AcuVid test soon after FDA approval.
“Right now, we're okay and there are other opportunities for us to raise money in the public markets,” he said.
After the FDA decision, the company also intends to win the coveted CE mark to market and sell the test across the EU (the company currently has the CE mark which gives permission to sell in some select European nations) and eventually Health Canada approval. The company also has plans to uplist on the OTCQX as it expands operations and its investor base.
But for the time being, completing the clinical study to secure EUA from the FDA and then bringing the test to market as soon as possible is all that matters.
“That's the main focus, but that's really what's been driving the value in the company and the need is there. So, we're all-hands-on-deck to get the AcuVid commercialized,” Fia said.
Contact the author: patrick@proactiveinvestors.com
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