SQI Diagnostics Updates Clinical Progress on Novel COVID-19 Tests Under Development for U.S. FDA Regulatory Submission
Company Confirms COVID-19 Antibody Home Test and Two Severity Triage Tests can be Submitted to U.S. FDA Under Emergency Use Authorization
TORONTO, Oct. 26, 2020 /PRNewswire/ - SQI Diagnostics Inc. (the "Company" or "SQI") (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 updated the Company's clinical development progress for its three novel Covid-19 tests, highlighted by confirmation from the U.S. FDA that Emergency Use Authorization (EUA) submission is acceptable for all three COVID diagnostic tests. SQI is accelerating the clinical development of its direct-to-consumer COVID-19 HOME Antibody Test, its COVID-19 RALI-dx™ Severity Triage Test and its COVID-19 RALI-fast™ Severity Triage Point-of-Care (POC) Test.
"We are currently advancing three important COVID-19 tests through clinical development with the intent to submit applications for Emergency Use Authorization to the FDA for all three, said Mr. Robert L. Chioini, Chief Executive Officer of SQI. Mr. Chioini further stated, "We believe our COVID-19 Antibody Home Collection Test will be differentiated by providing both speed and accuracy, delivering results in 24-48 hours with > 99% accuracy. Our COVID-19 Severity Triage Tests are unique because both have the potential to help save lives while reducing the burden and cost on healthcare systems. SQI is committed to our goal of making rapid diagnostic testing widely available to clinicians, patients, consumers and industry to help improve lives."
SQI's RALI-dx™ COVID-19 Severity Triage Test measures five critical biomarkers including IL-6 in approximately 50-minutes to help clinicians determine severe inflammatory response in patients with COVID-19 and whether they require hospital admission or not. SQI intends to submit RALI-dx for EUA to FDA in late Q4 2020. The RALI-dx™ COVID-19 Severity Triage Test is expected to be used primarily in hospital emergency departments upon FDA approval.
SQI's RALI-fast™ COVID-19 Severity Triage POC Test measures the key critical biomarker IL-6 in approximately 15-minutes to help clinicians determine severe inflammatory response in patients with COVID-19 and whether they require hospital admission or not. SQI intends to submit RALI-fast™ for EUA to FDA in late Q1 2021. The RALI-fast™ COVID-19 Severity Triage POC Test is expected to be used primarily in hospital emergency departments and urgent care centers upon FDA approval.
SQI's COVID-19 HOME Antibody Test identifies the presence of IgM, IgA and IgG antibodies of SARS-CoV-2 in individuals suspected to have been infected with COVID-19 and those wanting to know if they have been exposed. The test is > 99% accurate with results delivered conveniently in 24-48 hours. intends to submit its EUA to FDA in early Q1 2021. The COVID-19 HOME Antibody Test is expected to be used widely, including by school systems, businesses, sports teams, government and consumers at home.
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 the developmental direct-to-consumer COVID-19 HOME Antibody Test, the RALI-dx™ COVID-19 Severity Triage Test and the COVID-19 RALI-fast™ Severity Triage Point-of-Care (POC) Test. 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 be empowered to improve their health outcomes from the comfort of 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 HOME Antibody Test that identifies the presence of IgM, IgA and IgG antibodies of SARS-CoV-2 in individuals suspected to have been infected with COVID-19 and those wanting to know if they have been exposed. The test is > 99% accurate with results delivered quickly in 24-48 hours. The Company intends to apply for Emergency Use Authorization (EUA) to the FDA for its COVID-19 Antibody Test Kit. Upon EUA by FDA, the test could be one of the first antibody tests shipped direct to the consumer so individuals won't have to travel to a clinic or hospital to be tested for the presence of the SARS-CoV-2 antibody.
SQI is also fast-tracking the development of the RALI-dx™ COVID-19 Severity Triage Test and the RALI-fast™ COVID-19 Severity Triage POC Test. The RALI-dx™ measures five critical biomarkers including IL-6 in approximately 50-minutes and the RALI-fast™ measures the key critical biomarker IL-6 in approximately 15-minutes, both to assist in identifying severe inflammatory response in patients with suspected SARS-CoV-2 (or influenza) viral infection and to help clinicians determine whether patients require hospital admission or not. The Company intends to apply for EUA to the FDA for its RALI-dx™ COVID-19 Severity Triage Test and the RALI-fast™ COVID-19 Severity Triage POC Test.
The Company is not making any express or implied claims that its products can eliminate, cure or contain Covid-19 (or SARS-2 Coronavirus) at this time. For its research and development, the Company is collaborating with University Health Network (UHN) Hospitals, one of the largest health and medical research organization in North America.
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 forward-looking statements may be identified by words such as "anticipates", "plans", "proposes", "estimates", "intends", "expects", "believes", "may" and "will". The forward-looking 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, but not limited to, the following: the development and viability the Company's COVID-19 HOME Antibody Test, its COVID-19 RALI-dx™ Severity Triage Test and its COVID-19 RALI-fast™ Severity Triage Point-of-Care (POC) Test, the suitability of such tests for advanced clinical testing, including human trials, the content and timing of decisions made by the FDA relating to the use and commercialization of such tests, the timing and costs involved in establishing the commercialization of the tests, the impact that the ongoing COVID-19 pandemic may have on the company's business, including the expected development, manufacturing, regulatory and commercialization timelines relating to the aforementioned COVID-19-related tests. 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.
SOURCE SQI Diagnostics Inc.
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