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 /CNW/ - 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.
![SQI Diagnostics Inc. Logo (CNW Group/SQI Diagnostics Inc.) SQI Diagnostics Inc. Logo (CNW Group/SQI Diagnostics Inc.)](https://mma.prnewswire.com/media/1313233/SQI_Diagnostics_Inc__SQI_Diagnostics_Updates_Clinical_Progress_o.jpg)
"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.
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SOURCE SQI Diagnostics Inc.