Novel Diagnostics Target Organ Transplant, Autoimmune Disease and Serological Testing, Including Two Rapid Tests for COVID-19Toronto, OntarioSeptember 9, 2020SQI Diagnostics, Inc. (TSX-V: SQD; OTCQB: SQIDF),
a precision medicine company that discovers, develops, manufactures and commercializes innovative rapid diagnostic testing for healthcare professionals, patients and consumers worldwide, today announced it is expanding its proprietary rapid diagnostic testing portfolio targeting organ transplant, autoimmune disease and serological testing.
Mr. Robert L. Chioini, Chief Executive Officer of SQI stated, “Within our organ transplant, autoimmune disease and serological testing business units we have multiple products in clinical development, and we believe these advanced tests have the potential to offer patients and consumers significant benefit once they receive regulatory approval. Our COVID-19 At-home Antibody Test Kit and our COVID-19 Patient Triage Test are currently a top priority. We will provide more detail on our novel diagnostics, their clinical progress and our commercialization efforts shortly.” Mr. Chioini further stated, “Rapid diagnostic testing that is accurate and widely available is now more important than ever. It is intended that SQI’s direct-to-consumer diagnostic test kits will provide access to convenient, reliable, medical tests for use at home and empower people to improve their health outcomes, while our patient-based diagnostics will enable clinicians to provide fast effective treatment in the healthcare setting. SQI’s unique strategy of merging innovative diagnostics with differentiated health management services will enable us to provide comprehensive support for healthcare professionals, patients and consumers across the globe.”
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.
Chief Financial Officer
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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.
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