The big news in relation to the COVID-19 pandemic is, of course, the pending approvals and distribution of vaccines. Unfortunately, these vaccines will not immediately stop the spread of the virus. The reality is that it will be much later in 2021 before the vaccines can be administered to a significant majority of the population. Meanwhile, cases and hospitalizations and deaths are on the increase across North America, and we are just at the beginning of the winter season.
What can be done in the interim to limit the spread of COVID-19? Many experts point to the potential of rapid, inexpensive tests, administered twice a week or more on a massive scale, to greatly reduce the rate of infections. For instance, the nominated incoming director of the US Centers for Disease Control (CDC), Dr. Rochelle Walensky, MD, MPH, coauthored a study this summer that points to this approach as the most viable means of safely keeping college campuses open.
Tests that can be administered by the user, sampling saliva and providing results on site within minutes, could be the missing link that allows even asymptomatic carriers of the disease to limit their potential to infect others. One company, Therma Bright, Inc. (TSXV: THRM) is developing just such a test, CoviSafe™. Therma Bright is highly encouraged by its preliminary results showing appropriate accuracy levels, and anticipates sufficient testing to meet Emergency Use Authorization requirements in the next few weeks.
Test, Test, Test
In a recent article in Time magazine, Dr. Michael Mina, MD, PhD lays out the case for a national testing program utilizing “widespread frequent rapid antigen tests to stop the spread of the virus.” Of course, such a program would require the federal government to provide funding and logistical support to ensure the massive production and distribution of these types of tests. Health Canada says that it is now focused on reviewing/approving rapid antigen tests, including those utilizing saliva rather than nasal or throat swabs. This is a step in the right direction, as the country is falling woefully short of its stated goal of testing 200,000 people per day. Testing capacity needs to be at least doubled from what it is now, and participation rates increased even more dramatically, in order to meet that goal. The in-home, pregnancy-style fast antigen tests could provide that sort of boost.
In the US, the government has put nearly all of its eggs in the vaccine basket. Though this nearly singular approach could change with the incoming administration, the reality right now is that testing is falling far short of levels required to slow the spread of COVID-19. The US government announced distribution of 150 million Abbott BinaxNOW™ tests back in August. These tests require administration by a healthcare professional, but do return results in 15 minutes rather than hours or days. A quick perusal of the news yields a story from Maine about how the supply (the state got 400,000 tests earlier this fall) is about to run out due to the lack of federal funds. In Texas they are just now launching a rapid test pilot program for businesses in the state. This federal response does not appear to be an intensive and focused nationwide effort designed to meet the immense scale of the pandemic.
Potential of CoviSafe™
If Therma Bright is right about its testing solution, CoviSafe™ could be just the sort of test that could significantly impact disease rates. The US FDA requires for approval an accuracy rate of 80% when checked against the highly accurate but cumbersome PCR tests currently available. The study noted up top, regarding the safe opening of college campuses, hypothesized that an accuracy rate in the neighborhood of 70% would be effective in keeping infection rates manageable. Timeliness of results and the ability to regularly test without medical supervision are more important than 100% accuracy. CoviSafe™, with its at-home, saliva-based, rapid-results system, is just the sort of test to meet those benchmarks. Feasibility studies have shown CoviSafe™ to have an 80% rate of sensitivity (correctly identifying positive cases) combined with an over 90% rate of specificity (correctly identifying negative results).
Therma Bright has created a 50% owned venture, Torion Biosciences Inc., to spearhead the final testing and commercialization phases of product development. The company anticipates successful completion of testing, adequate to meet Emergency Use Authorization requirements in the US, Canada, and the European Union, very soon. If the company secures EUA, it will likely initially be for testing of symptomatic cases overseen by healthcare providers. Should that occur as anticipated, Therma Bright plans to then move quickly to get the test approved for in-home use for asymptomatic patients as well, looking to give schools, workplaces, events, and citizens the tools they need to conveniently monitor individual health.
CoviSafe™ is the type of test needed at this point in time, and in the future as the potential for other highly infectious pandemics remains high. Of course, the rubber has yet to meet the road as Therma Bright quickly moves through the product development and testing phases. Still, Therma Bright and CoviSafe™ deserve attention while most of the focus is on vaccines that could be months away from providing widespread protection.