FDA cites de-prioritization due to high
volume of EUA reviews; recommends other approval pathway for this
test
TORONTO, July 23, 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 FDA
will not continue its review of SQI's submission of the RALI-Dx™
IL-6 Severity Triage Test for Emergency Use Authorization under the
"Tests for Management of COVID-19 Patients" category. The agency
cites a high volume of EUA requests and its prioritization of EUA
reviews according to factors including the public health need for
the product and shortages of critical devices during the pandemic.
The FDA has encouraged SQI to submit an application under a non-EUA
regulatory pathway.
![SQI Diagnostics Inc. logo (CNW Group/SQI Diagnostics Inc.) SQI Diagnostics Inc. logo (CNW Group/SQI Diagnostics Inc.)](https://mma.prnewswire.com/media/1580643/SQI_Diagnostics_Inc__FDA_Stops_Emergency_Use_Authorization_Revie.jpg)
"This decision is disappointing for SQI," stated Mr.
Clive Beddoe, Interim CEO. "We were
encouraged by the positive dialogue with the FDA throughout the
review process, and we will continue with our efforts to seek FDA
regulatory clearance for this product in the US. The RALI-Dx™IL-6
Severity Triage Test has broad applicability in helping to identify
patients with severe inflammatory response arising from COVID-19
and other causes of respiratory distress. We are confident that the
FDA prioritization will support our upcoming COVID-19 HOME Antibody
Test submission under the EUA regulatory pathway."
About SQI Diagnostics
SQI Diagnostics is a life sciences and diagnostics company that
is leading the way in healthcare utilizing state-of-the-art
technology to rapidly diagnose, triage and provide medical insights
to patients. We strive to improve people's lives and assist their
healthcare providers by providing quality clinical health
information backed by years of research and clinical data. For more
information, please visit www.sqidiagnostics.com.
Contact:
Chief Financial Officer
Morlan Reddock
416.674.9500 ext. 277
mreddock@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 relating to future events or
future performance and reflect the current expectations and
assumptions of the Company regarding its growth, results of
operations, performance, business prospects and opportunities.
These statements generally can be identified by use of
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discussed herein could differ materially from those expressed or
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entirety by the inherent risks and uncertainties surrounding future
expectations. Important factors that could cause actual results to
differ materially from expectations include, among other things,
general economic and market factors, competition, 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
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SOURCE SQI Diagnostics Inc.