Novel Diagnostics Target Organ Transplant,
Autoimmune Disease and Serological Testing, Including
Two Rapid Tests for COVID-19
TORONTO, Sept. 9, 2020 /CNW/ - SQI Diagnostics Inc. ("SQI"
or the "Company") (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 >98%. 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, in collaboration with UHN, is nearing completion of
its initial study to determine viability of this test. Upon
successful completion of the trial, the Company plans to submit to
the FDA for Emergency Use Authorization.
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 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
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.