Windsor's Audacia Bioscience seeks Health Canada approval for quick, cheap COVID-19 test
Tuesday, April 14, 2020
The Windsor Star/Dave Waddell
Windsor’s Audacia Bioscience applied Monday to Health Canada for approval of a quick COVID-19 test that could provide a major boost in the battle to end the pandemic.
The test would provide users with results within 10 minutes.
“It’s done with a test kit the looks like one of those home pregnancy kits,” said Dr. Stephen Bartol, an orthopaedic surgeon who co-founded Audacia Bioscience with Phillip Olla.
“It’s a small plastic cassette and you put a couple of blood drops in a well and mix it with a solution. In five minutes you’ll know if you’re positive and we say wait 10 minutes to ensure you’re negative.”
Audacia Bioscience will apply to the U.S. Food and Drug Administration for the test’s approval this week.
In the meantime, the kits are being used to test health-care workers at Detroit’s Henry Ford Hospital as part of the clinical trials being conducted on various drugs to combat COVID-19.
“The FDA has indicated they will give us a same-day response,” said Bartol, the former chief of medicine for innovation in the Henry Ford Health System.
“Health Canada is also saying they’re expediting COVID testing approvals. We expect we should have approvals in a week to two weeks.”
The Audacia Bioscience test tracks anti-bodies in the blood to determine if an individual is infected. The current test being used in Canada tries to detect live virus by swapping the nose or sinus.
“The current tests are complicated, expensive and time consuming resulting in not many people getting tested,” Bartol said.
“We’re not testing enough people to know how widespread this pandemic is. In order to fight the pandemic, we need that information.”
Bartol said the swab test also doesn’t provide any information on those who have recovered from COVID-19.
“We have to test everyone,” Bartol said.
“This is a cheaper, faster and doesn’t require a lab.”
The Audacia Bioscience test can be done at clinics, pharmacies, doctor’s office, hospitals, long-term care facilities or just about anywhere and requires a pin prick to a finger in much the same way a diabetic tests for glucose.
Bartol said the cost of the kit would be about $20.
“Antibodies stay in your system, so you can tell if someone has currently got it, has recovered or is asymptomatic,” Bartol said. “You can do mass testing so you know how extensive the virus is. The data from mass testing will allow us to get a handle on the pandemic.”
Bartol said the test would help better protect health-care workers, first responders and any front-line employees dealing with public from being exposed.
In addition, the test will be able to measure the general population for lasting immunity.
“The way to get out of the pandemic is when enough immunity is built up in the community to resume normal life,” Bartol said.
“To do that, we’ll continue to need to test periodically to see if the immunity lasts. Understanding the asymptomatic carriers of the disease is really critical to this pandemic.
“They can spread it and with this test we can find these people.”
Audacia Bioscience has been working on the test since January after Chinese scientists produced a genome map of COVID-19.
The company reverse engineered the map. They then spent February testing 80 antigen solutions in China to finding the right mix.
After perfecting the solution, they returned to China for final testing on patients known to have COVID-19 and on those who had recovered from the virus.
“We were able to validate that it worked and was highly accurate,” Bartol said. “We got the final results two weeks ago.”
Bartol called the test kit “a nice made-in-Windsor story” as the testing solution used was developed locally. A local tool and die shop will make the moulds and produce the plastic kit containers.
The two parts of the kit will be sent to Windsor, Nova Scotia to a facility specializing in assembling such kits for distribution.
Bartol said an initial run of 150,000 kits would be produced to test the manufacturing process. The company will then produce 250,000 weekly and is in negotiations with more manufacturers to scale up further.