TORONTO, Oct. 19, 2021 /CNW/ - SQI Diagnostics Inc. ("SQI"
or the "Company") (TSXV: SQD) (OTCQB: SQIDF), a life sciences and
diagnostics company that develops and commercializes proprietary
technologies and products for advanced microarray diagnostics,
today responded to a recent shift in US Food and Drug
Administration (FDA) priorities around Emergency Use Authorization
(EUA).
The FDA has announced that, because the COVID-19 pandemic has
moved into a new phase with respect to testing, it is no longer
prioritizing the review of at-home testing and home sample
collection for COVID-19 antibody tests under EUA.
This shift will de-prioritize the review of all these devices
already submitted for FDA consideration. However, because SQI had
not yet submitted its EUA application it is now able to move from a
patient self-collection model to one in which a trained medical
professional will collect a whole blood sample.
"As we have seen throughout the pandemic, changing government
and regulatory priorities in the face of new or evolving
circumstances is to be expected," said Andrew Morris, President and CEO of SQI
Diagnostics Inc. "SQI is in the fortunate position of being able to
pivot our ongoing clinical validation study to meet the new
priorities of the FDA for EUA review."
SQI plans to pursue a modified intended-use claim that fits with
the FDA's current emphasis of convenient testing and meeting the
public health need.
SQI believes that its collection of fingerstick capillary
samples by trained medical professions would offer a pain-free
sample collection option for a quantitative COVID-19 antibody test
that is convenient for patients. SQI's approach would make rapid
and accurate testing more available in places where people are
already accessing COVID-19 testing such as drive-through clinics,
pharmacies, the workplace and other institutional settings.
About SQI Diagnostics
SQI Diagnostics is a life sciences and diagnostics company that
develops and commercializes proprietary technologies and products
for advanced microarray diagnostics. The Company's proprietary
microarray tests and fully automated systems are designed to
simplify protein and antibody testing workflow, increase
throughput, reduce costs and provide excellent data quality. For
more information, please visit www.sqidiagnostics.com.
Contact:
Morlan Reddock
Chief Financial Officer
437-235-6563
mreddock@sqidiagnostics.com
FORWARD-LOOKING INFORMATION
This news release contains certain forward-looking
statements, including, without limitation, statements containing
the words "will", "may", "expects", "intends", "anticipates" and
other similar expressions which constitute "forward-looking
information" within the meaning of applicable securities laws.
Forward-looking statements reflect the Company's current
expectation and assumptions, and are subject to a number of risks
and uncertainties that could cause actual results to differ
materially from those anticipated. The forward-looking statements
in this news release include without limitation, statements with
respect to the Private Placement, the Debenture Repayment and the
use of proceeds of the Private Placement. These forward-looking
statements are qualified in their entirety by the inherent risks
and uncertainties surrounding future expectations. Important
factors that could cause actual results to differ materially from
expectations include, but are not limited to, risks related to the
failure to obtain necessary regulator and stock exchange approvals
for the Private Placement, general economic and market factors,
competition, the development and commercialization of the Company's
diagnostics tests, the effect of the global pandemic and consequent
economic disruption, and the factors detailed in the Company's
ongoing filings with the securities regulatory authorities,
available at www.sedar.com.
Although the forward-looking statements contained herein
are based on what we consider to be reasonable assumptions based on
information currently available to us, there can be no assurance
that actual events, performance or results will be consistent with
these forward-looking statements, and our assumptions may prove to
be incorrect. 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 laws.
This news release does not constitute an offer to sell or
a solicitation of an offer to sell any of the securities in
the United States. The securities
have not been and will not be registered under the U.S. Securities
Act or any state securities laws and may not be offered or sold
within the United States or to
U.S. persons unless registered under the U.S. Securities Act and
applicable state securities laws or an exemption from such
registration is available.
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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.