TORONTO – Toronto-based Sqi Diagnostics Inc. has reported significant clinical progress developing three novel COVID-19 tests for submission for U.S. FDA emergency use authorization. Sqi is accelerating the clinical development of its COVID-19 Home Antibody Test, COVID-19 Severity Triage Test and a similar severity test for point-of-care applications.

“We’re in the process right now of manufacturing those kits and developing those products,” Sqi’s CSO Eric Brouwer told BioWorld. “We have also been exploring additional advanced manufacturing techniques with researchers at McMaster University to make that manufacturing process faster while maintaining the quality and the result.”

Taking the measure of COVID-19

Questions have swirled ever since COVID-19 emerged as a threat, e.g., how rapidly does it spread, who’s likely to be infected and just how sick will they be. The severity of patient sickness is the target for Sqi’s Rali-dx COVID-19 Severity Triage Test which detects five cytokines or inflammatory proteins, including Interleukin-6 (IL-6) which is key to measuring the severity of COVID-19.

Of particular concern is a severe immune reaction called the “cytokine storm” in which acute lung injury occurs when the body releases too many cytokines into the blood too quickly. The immune system has effectively “gone into overdrive with an overproduction of interleukins, of which IL-6 is one,” Brouwer explained. “Detecting elevated IL-6 is an emerging indication of a severe COVID-19 response in the patient.”

Both the Rali-dx Severity Triage Test, and a similarly named, 15-minute point-of-care test seek out the IL-6 biomarker to determine if the inflammatory response to COVID-19 is so serious it requires immediate hospital admission.

A third test, the COVID-19 Home Antibody Test identifies antibodies in SARS-CoV-2 in individuals possibly infected with COVID-19. More than 99% accurate (with results produced in 24 to 48 hours) that test is expected to be used by schools, businesses, sports teams, government and consumers at home.

Smart surface

Sqi worked with researchers at Hamilton, Ontario’s McMaster University on “smart surface” technology that repels elements in human blood that impede detection of IL-6 critical for measuring the severity of COVID-19. “That core technology makes it possible to detect and measure IL-6 with unprecedented accuracy and sensitivity at very low concentrations,” said Brouwer. “It also enables us to report results that are highly relevant to physicians in under an hour.”

The smart surface is actually a proprietary coating inside the bottom of ninety-six test tubes seated in a 3” x 6” microtiter plate. In each test tube multiple sensors breed between five and 10 proteins simultaneously, including the IL-6 marker. The problem, Brouwer explained, occurs when extraneous components of blood at the surface of a sample interfere with a sensor’s signal, producing false results.

“What we try to do is reduce that effect through signal averaging across those sensors which enhances signal intensity and signal-to-noise characteristics. That means more signal, less noise or interference.”

Where’s the market access?

Prior to development of its smart surface innovation, Sqi already had a path to the market through existing, revenue-generating products, Brouwer noted. These include a direct-to-consumer Celiac Disease test and a Rheumatoid Arthritis (RA) Test that enables people to screen for these diseases from their homes.

“There are future opportunities to apply these smart surfaces into our product lines to enhance our competitive advantage, whether that’s in performance, reduced cost or improved speed of manufacture,” said Brouwer.

Other diseases mean more opportunities, notably measuring disease severity in patients with influenza or other acute respiratory distress conditions, but also cancer. “Taking a look at inflammation as an underlying mechanism for a lot of disease states is kind of where the medical community has been for the past couple of years,” said Brouwer.

The smart surface is core technology that will advance the medical community’s understanding and use of inflammatory markers for measuring disease. Said Brouwer, “that technology represents the next generation of manufacturing techniques and opportunities for us to stay current with innovations.”