SQI Diagnostics and McMaster University Researchers Create New Technology to Better Measure Severity of COVID-19 Disease

TORONTO, Oct. 20, 2020 /PRNewswire/ - SQI Diagnostics Inc. (TSX-V: SQD) (OTCQX-US: SQIDF), a precision medicine company that discovers, develops, manufactures and commercializes innovative rapid diagnostic testing for healthcare professionals, patients and consumers worldwide, today announced that it, in collaboration with McMaster University researchers, created a new technology that can detect an elusive protein bio-marker from human blood to measure the severity of COVID-19.

Researchers at McMaster University (Hamilton, ON) in collaboration with SQI have created a surface that repels every other element of human blood except critical cytokine biomarkers like Interleukin-6 (IL-6), enabling timely and clear detection of critical “cytokine storm” progress of COVID-19 in individual patients. The same bio-sensing technology can also be used to measure disease severity in patients with influenza or other acute respiratory distress conditions, as well as other infectious and non-infectious diseases, including some cancers.

Dr. Tohid Didar, Professor of Mechanical Engineering at McMaster stated, “There are so many possibilities for these smart surfaces. We can create them to repel everything, or we can design them to interact in many beneficial ways. In this application, we have designed it to detect only the one bio-marker IL-6, and this allows us to separate it from everything else in a very complex environment, enabling clear quantitative detection of its presence.”

The innovative technology is a proprietary surface coating that repels every component of blood and other complex fluids, while containing microscopic molecules that attract IL-6, making it possible to detect and measure IL-6 with unprecedented accuracy and sensitivity, at concentrations as low as 0.5 picograms per mL – or one half of one trillionth of a gram per mL.

Dr. Eric Brouwer, Chief Scientific Officer of SQI Diagnostics, said “Our collaboration with McMaster University has led to an innovative pathway to a potentially more efficient and effective manufacturing design that strengthens SQI’s ability to provide extremely accurate diagnostics for testing in the COVID-19 pandemic, as well as other critical conditions.”

SQI and the McMaster researchers are working on a process to adapt the technology into SQI’s existing testing platforms, with the goal of moving it into use as soon as possible. A paper introducing the technology has been published the weekly, peer-reviewed scientific journal covering nanotechnology called Small.

About SQI Diagnostics

SQI Diagnostics, Inc. is a precision medicine company that discovers, develops, manufactures and commercializes innovative rapid diagnostic testing for healthcare providers, patients and consumers worldwide. The Company’s proprietary advanced diagnostics target organ transplant, autoimmune disease and serological testing, which include a developmental COVID-19 Patient Triage Test (RALI-Dx^™) and a direct-to-consumer COVID-19 Antibody Test Kit. SQI’s rapid diagnostic tests are sold to healthcare professionals so that patients can get accurate results and fast effective treatment, and direct-to-consumers so that individuals can take action to improve their health outcomes from the comfort of their home.

Under organ transplant, SQI is pioneering the development of an advanced diagnostic test that increases the chance of successful lung transplant by assessing the health of the donor organ prior to transplant surgery. The Company’s TORdx^™ Lung Test can detect inflammation at the molecular level enabling surgeons to make a “go” or “no-go” decision on initiating transplantation; there is currently no other such test. SQI has partnered with University Health Network (UHN) Hospitals, one of the largest health and medical research organization in North America, for the TORdx^™ Lung Test clinical development program. SQI is working with agencies in both the U.S. and Canada to submit the TORdx^™ Lung Test for regulatory approval. Additional diagnostic tests designed to increase the chance of successful organ transplant for the kidney and liver are planned for clinical development post-regulatory approval of the TORdx^™ Lung Test.

Under autoimmune disease testing, SQI has a direct-to-consumer Celiac Disease and a Rheumatoid Arthritis (RA) Test that enable people to screen for the diseases from the comfort of their home. The direct-to-consumer RA Test can help identify and confirm RA symptoms for early care. The direct-to-consumer Celiac Test is the only test that confirms the disease and that can also validate the effectiveness of dietary and lifestyle changes to confirm the autoimmune response is improving.

Under serological testing, SQI is fast-tracking the development of a direct-to-consumer COVID-19 At-home Antibody Test Kit to detect the presence of SARS-CoV-2 antibodies in the blood. The Covid-19 Antibody Test Kit will determine if someone has been exposed to the SARS-CoV-2 virus and the degree of exposure and possible immunity to it. SQI’s COVID-19 Antibody Home Test Kit will be highly accurate >99%. The Company intends to apply for FDA Emergency Use Authorization (“EUA”) for its COVID-19 Antibody Test Kit. If EUA is obtained, this test could be the first or one of the first antibody tests shipped direct to the consumer home or business so individuals won’t have to travel to a clinic or hospital to be tested for the presence of SARS-CoV-2 antibody.

SQI is also fast-tracking the development of a COVID-19 Triage Test called the RALI-Dx^™. The RALI-Dx^™ test is an Inflammatory Response Panel comprised of several biomarkers indicative of the “cytokine storm” that is associated with acute lung injury. The RALI-Dx^™ delivers results in under an hour, giving the clinician insight into whether a patient with COVID-19, Flu or any upper respiratory condition, can be treated and released for home care, should be admitted to a standard hospital unit to be monitored, or is likely to develop severe life-threatening symptoms and requires immediate intensive care unit (ICU) admittance and advanced respiratory care measures. The ability to effectively triage COVID-19 (or Flu) patients would be a diagnostic industry first. The Company intends to apply for FDA EUA for its COVID-19 Triage Test.

The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) at this time.

For more information, please visit www.sqidiagnostics.com.

FORWARD-LOOKING INFORMATION

This press release contains certain words and statements, which may constitute “forward-looking statements” within the meaning of applicable securities laws. Such statements reflect the current views of the Company with respect to future events and are subject to certain risks and uncertainties detailed in the Company’s ongoing filings with the securities regulatory authorities, available to the public at www.sedar.com. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company’s control, that may cause actual events or results to differ materially from the company’s current expectations. Management’s expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: the content and timing of decisions made by the FDA, the timing and costs involved in establishing a commercial organization and the impact the ongoing COVID-19 pandemic may have on the company’s business, including its expected development, manufacturing, regulatory and commercialization timelines Readers are cautioned not to place undue reliance on these forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements either as a result of new information, future events or otherwise, except as required by applicable securities laws

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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SOURCE SQI Diagnostics Inc.