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 from the National Research Council of Canada, it received a from Ontario Electricity Generator and a to accelerate production of the units. Said production is expected to lead to and an additional 750 indirect jobs. Its stock price has also done quite well over the past year.
Kontrol鈥檚 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鈥攚here tiny molecules are captured, extracted and tested to help detect disease鈥攖here are many elements of this 鈥渕ade in Canada鈥� story that don鈥檛 add up to me. And it begins with the magic sauce.
鈥淰ision without execution is hallucination,鈥� said Edison
The claim made by the company is tall: this device monitors the air in the room (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 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 鈥渧iral targets.鈥� If the virus is present, it will stick to them, and a 鈥渞eagent鈥� 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 鈥渧iral target鈥� and this 鈥渞eagent.鈥� A molecule that is also stuck to the reagent then gets excited by the BioCloud鈥檚 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 about the detection of the coronavirus in the air and who is working on a low-cost bioaerosol sensor. 鈥淲hat they are proposing,鈥� he wrote to me via email, 鈥渟eems to be a variation of a reasonably well established聽double-antibody sandwich-type detection (ELISA-based detection) or the rapid antigen test that is available for SARS-CoV-2.鈥� 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 鈥渧ery likely that the ambient particles will coat the surface, preventing the virus from binding to the target.鈥�
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. 鈥淲e have a very stable--we call it our 鈥榬eagent.鈥� If you鈥檙e referring to it as antibodies because of your science background, you know, that鈥檚 fine, but we don鈥檛 specifically say what our reagent is. And that鈥檚 part of our, if you will, our secret sauce.鈥� Kontrol has 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鈥檚 behalf doesn鈥檛 know what the 鈥渞eagent鈥� is. 鈥淲e keep the secret sauce under lock and key and we supply our contract manufacturer,鈥� 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鈥檛 tell me how, 鈥渇or proprietary reasons.鈥�
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. 鈥淏ased on what is presented, I鈥檓 very doubtful that they will be able to detect SARS-CoV-2 under concentrations typically expected in most indoor spaces.鈥�
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. 鈥淚 assume they will have to have many reagent vials/dishes that the system rotates out periodically. If it鈥檚 designed for daily sample analysis, they need 90 of them for three months.鈥� But if it鈥檚 roughly five times an hour as claimed, the number inflates considerably. 鈥淥f course,鈥� he continued, 鈥測ou can have a service person changing it periodically as we do for conventional air quality sampling, but we don鈥檛 call that 鈥榓utomated鈥� sampling.鈥�
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 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. 鈥淚t鈥檚 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鈥檙e the core team that brought this to life.鈥� 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. 鈥淕ary 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.鈥�
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. 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 as rather boldly claiming that 鈥渙ur results are absolutely conclusive.鈥� His Twitter feed makes no mention of the BioCloud nor has Western University鈥檚 media relations office ever released a statement about it. Yet by one of its distributors, Davis Controls, claims the technology is 鈥減roven鈥� and 鈥渂acked by leading virologists.鈥� Plural.
As for the manufacturer that has been contracted to assemble the BioCloud at an initial maximum capacity of, they specialize in 鈥渇rom the major leagues to little leagues and every league in between.鈥� They are housed in a small building in London, Ontario. Their tagline? 鈥淲here the never been done before is what we excel at every day.鈥�
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, I get hit with this: secret sauce. Proprietary information. Patent pending. We drew antibodies on the diagram but we鈥檙e not necessarily implying they鈥檙e antibodies. It鈥檚 a 鈥渞eagent.鈥�
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 to, replacement cartridges sell for CAD, and Ghezzi himself has mentioned wanting to charge for. His company has already roped in a number of distributors who are expected to move 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 states, 鈥渘o warranty of fitness for any particular purpose [...] is made concerning the goods.鈥� This is not a medical device, as it does not diagnose a disease in a human. 鈥淚t has not and does not need to be approved by Health Canada or any similar medical device regulatory agency.鈥� 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, who was doling out praise: 鈥淭o build this, the product, government funding, manufacturing in place, distribution agreements, and in this short a time? It鈥檚 diabolical. It鈥檚 unbelievable.鈥�
