Company Intends to Use Patient Data for
Emergency Use Authorization (EUA) Submission to U.S.
FDA
TORONTO, Jan. 25, 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, today announced
that patient enrollment began for the Company's clinical study for
its direct-to-consumer COVID-19 HOME Antibody Test with the data to
be used to support its EUA regulatory submission to the U.S.
FDA.
The clinical study is being conducted in the United States and will analyze blood
samples from both COVID-19 positive and negative subjects to meet
FDA EUA guidelines. Blood samples are taken by the subjects at home
and shipped and tested on SQI's automated sqidlite®
system. The clinical study for SQI's COVID-19 HOME Antibody Test is
anticipated to conclude in early second quarter 2021.
"Once the study is completed, we intend to submit our COVID-19
HOME Antibody Test to the FDA's EUA pathway to expedite its
approval for sale in the U.S.", stated Mr. Robert L. Chioini, CEO of SQI Diagnostics. "Upon
EUA approval, we believe the COVID-19 HOME Antibody Test will be
the first of its kind, with its exclusive ability to measure three
isotypes (IgA, IgM, and IgG) of the SARS-CoV-2 antibodies from a
single finger-prick blood sample, providing a fast result within
24-48 hours with 99% accuracy, without the inconvenience of
consumers having to leave their home or place of business to be
tested."
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 three COVID-19
diagnostic tests: a direct-to-consumer COVID-19 Antibody Test and
two COVID-19 Severity Triage tests. The 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 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™ COVID-19 Severity Triage Test and the
RALI-fast™ COVID-19 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
or not. Both tests measure the critical biomarker IL-6 which plays
a key role in the cytokine storm phase of COVID-19. The RALI-dx™
delivers results from the lab in about 50 minutes while the
RALI-fast™ delivers results at the patient
point-of-care in about 15 minutes. The Company currently expects to
apply for EUA to the FDA and for an Interim Order with Health
Canada for both tests in the first and second quarters of calendar
year 2021, respectively.
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 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.
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 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.
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.