Test Designed to Assist in Identifying
Severe Inflammatory Response in Patients with
Confirmed COVID-19 Illness
TORONTO, April 1, 2021 /CNW/ - SQI Diagnostics Inc. (the
"Company" or "SQI") (TSXV: SQD) (OTCQB: SQIDF), a precision
medicine company that discovers, develops and commercializes
innovative rapid diagnostic testing for healthcare professionals,
patients and consumers worldwide, announces that it has submitted
its fully completed clinical and analytical data package to the
U.S. Food and Drug Administration (FDA) for emergency use
authorization (EUA) of its RALI-Dx™ IL-6
Severity Triage Test. The submission was completed on March 31, 2021. The FDA will review the
application under its pre-emergency use authorization (PEUA)
process before a definitive EUA review. Subject to the acceptance
of an EUA, the RALI-Dx™ IL-6 Severity Triage Test
is intended to be utilized by hospital emergency departments and
labs to assist clinicians in identifying severe inflammatory
response in patients with confirmed COVID-19 illness to aid in
determining the risk of intubation with mechanical ventilation.
![SQI Diagnostics Inc. Logo (CNW Group/SQI Diagnostics Inc.) SQI Diagnostics Inc. Logo (CNW Group/SQI Diagnostics Inc.)](https://mma.prnewswire.com/media/1478144/SQI_Diagnostics_Inc__SQI_Diagnostics_Submits_RALI_Dx__IL_6_Sever.jpg)
"Our priority is to help address this global health emergency",
stated Mr. Robert L. Chioini, CEO of
SQI. "The development and advancement of a test to help identify
and determine which COVID-19 patients are at risk of a severe
adverse respiratory event is one of our highest priorities in
helping combat this expanding health emergency. We think the
RALI-Dx™ IL-6 Severity Triage Test is an important
risk assessment tool that can help manage the care of hospitalized
COVID-19 patients and the overflow of hospital admissions."
About SQI Diagnostics
SQI Diagnostics Inc. is a precision medicine company that
discovers, develops, 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 COVID-19 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 intended to be 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.
SQI is fast-tracking the development of its COVID-19 diagnostic
tests: a direct-to-consumer COVID-19 HOME Antibody Test and two
COVID-19 Severity Triage Tests. The COVID-19 HOME Antibody Test
identifies the semi-quantitative presence of IgM, IgA and IgG
antibodies of SARS-CoV-2 in individuals who have been infected with
COVID-19, individuals who have been vaccinated or asymptomatic
individuals wanting to know if they have been exposed. The test is
> 99% accurate with results delivered in 24-48 hours. The
Company currently expects to apply to the U.S. Food and Drug
Administration ("FDA") for Emergency Use Authorization ("EUA")
for its COVID-19 HOME Antibody Test in the second quarter of
calendar year 2021. Should the COVID-19 HOME Antibody Test receive
regulatory approval, the test is expected to be available
direct-to-consumer which would allow individuals to avoid
travelling to a clinic or hospital to be tested for the presence of
the SARS-CoV-2 antibody.
The RALI-Dx™ IL-6 Severity Triage Test and the
RALI-fast™ IL-6 Severity Triage POC Test each
help clinicians identify which patients with SARS-CoV-2 will have a
severe inflammatory response and should be admitted to the hospital
to aid in determining the risk of intubation with mechanical
ventilation. Both tests measure the critical biomarker IL-6 which
plays a key role in the cytokine storm phase of COVID-19. The
RALI-Dx™ IL-6 Severity Triage Test delivers results from
the lab in about 50 minutes while the RALI-fast™
IL-6 Severity Triage POC test delivers results at the patient
point-of-care in about 15 minutes. The Company currently expects to
apply for an Interim Order with Health Canada for the
RALI-Dx™ IL-6 Severity Triage Test and an EUA with FDA
for RALI-fast™ IL-6 Severity Triage POC Test in the
second quarter of calendar year 2021.
With 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 developmental
TORdx™ LUNG Test can detect inflammation at the
molecular level to assess the health of the donor lung, enabling
surgeons to transplant healthy lungs which otherwise would have
been rejected; there is currently no other such test. SQI has
partnered clinical development with the University Health Network
(UHN) Hospitals, one of the largest health and medical research
organizations in North America.
Upon regulatory approval of the TORdx™ LUNG Test,
clinical development is planned for diagnostic tests designed to
increase the chance of successful kidney and liver transplant.
For 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 timely care and treatment. The direct-to-consumer
Celiac Test confirms disease and validates the effectiveness of
dietary and lifestyle changes to confirm the autoimmune response is
improving.
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 UHN Hospitals, one of the largest
health and medical research organizations in North
America.
There are no assurances that SQI will be successful at receiving
EUA acceptance for the RALI-Dx™ IL-6 Severity
Triage Test or any of its other developmental COVID-19 related
diagnostic tests.
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. The forward-looking statements in this press release
include, without limitation, statements with respect to the use and
allocation of the proceeds of Funding. 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.