Imagine a wall-mounted device that continuously scans the air and alerts you to the presence of the coronavirus. This would be a boon for commercial buildings, hospitals, schools, and mass transit hubs during this interminable pandemic, allowing their administrative staff to quickly shut down an area and thus quell any local outbreak.
This device, we are led to believe, exists. It is called the BioCloud and is the brainchild of a London, Ontario-based company called CEMSI. This company was acquired in 2018 by Kontrol Technologies Corp, based just north of Toronto, which specializes in energy efficiency and air quality.
The hype for the BioCloud is tangible in the media. After being granted $50,000 in federal funding from the National Research Council of Canada, it received a $750,000 emission order from Ontario Electricity Generator and a $2 million commitment from the Ontario government to accelerate production of the units. Said production is expected to lead to 250 direct jobs and an additional 750 indirect jobs. Its stock price has also done quite well over the past year.
Kontrol’s BioCloud is thus positioned as a job creator and a saviour of the economy, a way to bring employees back to work safely, all under the patriotic banner of a device that showcases Canadian ingenuity.
I want the BioCloud to work. But as someone who worked for many years in molecular diagnostics—where tiny molecules are captured, extracted and tested to help detect disease—there are many elements of this “made in Canada” story that don’t add up to me. And it begins with the magic sauce.
“Vision without execution is hallucination,” said Edison
The claim made by the company is tall: this device monitors the air in the room every six to fifteen minutes (depending on the size of the room) and checks for the coronavirus through the use of a proprietary reagent cartridge that sits inside a detection chamber. This detection chamber and its reagent need only be changed a) if the device detects the coronavirus in the air or b) after three to four months of monitoring during which the virus was not detected. So what exactly happens inside this detection chamber?
The company released a “reference paper” on its website that provides an illustration of how the BioCloud is meant to work. Coating the bottom of the chamber, there are things that will bind to the coronavirus: these things are referred to as “viral targets.” If the virus is present, it will stick to them, and a “reagent” will then bind to the virus. This reagent is clearly drawn in the unique shape of an antibody, of the sort our bodies make to defend ourselves against the virus and which are commonly used in molecular biology laboratories to detect specific proteins. We are thus left with the virus sandwiched in between this “viral target” and this “reagent.” A molecule that is also stuck to the reagent then gets excited by the BioCloud’s laser and emits light at a specific frequency, and this is picked up by a detector. Boom: alert! alert! The coronavirus has been detected.
I showed this diagram to Dr. Suresh Dhaniyala, professor in the department of mechanical and aeronautical engineering at Clarkson University who co-wrote an article in The Conversation about the detection of the coronavirus in the air and who is working on a low-cost bioaerosol sensor. “What they are proposing,” he wrote to me via email, “seems to be a variation of a reasonably well established double-antibody sandwich-type detection (ELISA-based detection) or the rapid antigen test that is available for SARS-CoV-2.” Indeed, this looks like a common laboratory test, so why is it that no one thought to stick it in a wall-mounted box before? As Dr. Dhaniyala pointed out to me, air is not a pristine solution. It has a lot of particles, only of few of which could contain the virus, making it “very likely that the ambient particles will coat the surface, preventing the virus from binding to the target.”
Another problem in my experience is the temperature. Antibodies are not meant to be kept at room temperature for three to four months at a time. I reached out to one of the major biotech companies selling antibodies and was told they only have stability data at room temperature for one week. They recommend their customers store the precious reagent in the fridge when not in use. How is the BioCloud managing to store four months worth of antibodies at room temperature to dispense for automated testing every six to fifteen minutes?
I had to know what was going on, so I spoke to Paul Ghezzi, the CEO of Kontrol. “We have a very stable--we call it our ‘reagent.’ If you’re referring to it as antibodies because of your science background, you know, that’s fine, but we don’t specifically say what our reagent is. And that’s part of our, if you will, our secret sauce.” Kontrol has filed for patents both in the United States and in Canada and has been very guarded about what it is that makes the machine do what it claims to do. Even the company that has been contracted to manufacture the BioCloud on Kontrol’s behalf doesn’t know what the “reagent” is. “We keep the secret sauce under lock and key and we supply our contract manufacturer,” Mr. Ghezzi specified. The reagent is currently purchased from the United States and Kontrol is trying to find a Canadian supplier instead.
As for the temperature inside the box, Mr. Ghezzi claims they can monitor and regulate the temperature as required but he wouldn’t tell me how, “for proprietary reasons.”
The details the company has voluntarily released in its so-called reference paper (including some partial validation studies that did not test the claimed laser-assisted automated detection) make Dr. Dhaniyala skeptical. “Based on what is presented, I’m very doubtful that they will be able to detect SARS-CoV-2 under concentrations typically expected in most indoor spaces.”
For Dr. Chang-Yu Wu, a professor in the Department of Environmental Engineering Sciences at the University of Florida, there is a lack of information about how the BioCloud is supposed to maintain continuous monitoring for so long. “I assume they will have to have many reagent vials/dishes that the system rotates out periodically. If it’s designed for daily sample analysis, they need 90 of them for three months.” But if it’s roughly five times an hour as claimed, the number inflates considerably. “Of course,” he continued, “you can have a service person changing it periodically as we do for conventional air quality sampling, but we don’t call that ‘automated’ sampling.”
Extraordinary claims require extraordinary evidence and, in this particular case, extraordinary expertise as well. Did the company have the scientific know-how to pull this off?
Pulling game-changing science out of thin air
CEMSI is where the brain of the operations allegedly resides. It is a one-story brick building that sits between a Sherwin-Williams paint store and a bingo hall in London, Ontario. Their expertise is in measuring oxygen and moisture and dust in the air. Detection of viruses through molecular testing? Not so much. I checked the backgrounds of everyone listed on their website and everyone attached to the company through LinkedIn and only found one person who had some tangential link to molecular biology. Gary Saunders, the president of Kontrol and the vice president of operations at CEMSI, lists both business and chemistry studies at Western University from 2005 to 2009. He has been employed at CEMSI since 1992 and moved up the ranks over the years.
I asked Paul Ghezzi to tell me who had been responsible for the development of the detection technology inside the BioCloud. “It’s a team effort but our wholly-owned subsidiary is called CEM Specialties Inc. (CEMSI) and they have a 30-year track record of working in industrial facilities for very specific particulate emissions. They’re the core team that brought this to life.” There is of course a big gap between knowing how to detect dust and knowing how to accurately detect a specific virus in ambient air. When I pushed him for the names of the people involved in the molecular R&D, he pointed to Gary Saunders. “Gary has kind of a rich and deep history in all this. The technology is a combination of our knowledge in air sampling and continuous emission monitoring and the science of identifying the virus.”
The reference paper cites three laboratories as having participated in the validation of the BioCloud: the Heinrichs lab, the Dikeakos lab, and the ImPaKT lab, all of which are located at Western University. Both Jimmy Dikeakos and David E. Heinrichs are listed as part of the ImPaKT lab team. I tried to reach the ImPaKT lab itself and its director left me a voicemail message mentioning that he thought all testing for the BioCloud was being done by David Heinrichs. Dr. Dikeakos recommended me via email that I direct all queries to the makers of the BioCloud as he does not and cannot speak for them. Meanwhile, Dr. Heinrichs was unreachable by either phone, email, or Twitter. He is quoted in a September 2020 press release as rather boldly claiming that “our results are absolutely conclusive.” His Twitter feed makes no mention of the BioCloud nor has Western University’s media relations office ever released a statement about it. Yet an ad for the BioCloud by one of its distributors, Davis Controls, claims the technology is “proven” and “backed by leading virologists.” Plural.
As for the manufacturer that has been contracted to assemble the BioCloud at an initial maximum capacity of 10,000 units per month, they specialize in sports scoreboard solutions “from the major leagues to little leagues and every league in between.” They are housed in a small building in London, Ontario. Their tagline? “Where the never been done before is what we excel at every day.”
The miracle of London, Ontario
What I am left to consider is a stainless steel box that is claimed to test ambient air five times an hour for three to four months at a time with no need to feed it more reagents, and whenever I ask how this tiny, bullish company with no expertise in virus detection figured out what DARPA is asking experts to solve, I get hit with this: secret sauce. Proprietary information. Patent pending. We drew antibodies on the diagram but we’re not necessarily implying they’re antibodies. It’s a “reagent.”
What I also observe are media outlets simply parroting the press releases from this company. Journalists are overworked and newsrooms are understaffed, and a feel-good story about a local company coming to save our workplaces from the pandemic may not trigger our instinct to be rigorous. But it should. The BioCloud is a big investment. Its listed price is CAD 15,000 to 20,000, replacement cartridges sell for CAD 500, and Ghezzi himself has mentioned wanting to charge for a maintenance package. His company has already roped in a number of distributors who are expected to move 250 units a year to keep their non-exclusivity pricing. And these boxes with their super-secret sauce may end up being bought by people who would like some guarantee that they work. Unfortunately, as the BioCloud exclusive distribution agreement states, “no warranty of fitness for any particular purpose [...] is made concerning the goods.” This is not a medical device, as it does not diagnose a disease in a human. “It has not and does not need to be approved by Health Canada or any similar medical device regulatory agency.” Caveat emptor.
Last January, Paul Ghezzi was interviewed on a YouTube channel devoted to connecting investors with public companies. I can find no better way to end this than to quote the host, who was doling out praise: “To build this, the product, government funding, manufacturing in place, distribution agreements, and in this short a time? It’s diabolical. It’s unbelievable.”
