SQI Diagnostics Inc. Responds to Change in FDA Priorities in Emergency Use Authorization

Rhea-AI Summary

SQI Diagnostics Inc. (SQIDF) has responded to a significant shift in FDA priorities regarding Emergency Use Authorization (EUA) for COVID-19 tests. The FDA will no longer prioritize at-home testing for COVID-19 antibody tests, which affects devices awaiting review. SQI, which has not yet submitted its EUA application, will pivot to a model where trained medical professionals collect samples. This strategy aligns with the FDA's current focus on convenient testing and aims to enhance patient experience through pain-free fingerstick sample collection in various accessible locations.

Positive

• SQI can pivot to a trained medical professional model for sample collection after the FDA shift.
• The new approach allows SQI to align its testing strategy with current FDA priorities.

Negative

• FDA's de-prioritization of at-home tests may affect SQI's market position.
• Devices already submitted for EUA consideration will face delays due to the shift in FDA focus.

TORONTO, Oct. 19, 2021 /PRNewswire/ - 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.

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.

FAQ

What changes has SQI Diagnostics made in response to FDA priorities on COVID-19 testing?

SQI Diagnostics now plans to transition from at-home testing to a model where trained medical professionals collect samples for COVID-19 antibody tests.

How does the FDA's recent decision impact SQI Diagnostics' EUA application?

The FDA's decision to no longer prioritize at-home COVID-19 antibody testing allows SQI to pivot its strategy, as it had not yet submitted its EUA application.

What is the stock symbol for SQI Diagnostics Inc.?

The stock symbols for SQI Diagnostics Inc. are TSXV: SQD and OTCQB: SQIDF.

When was the press release regarding SQI Diagnostics' response to FDA changes issued?

The press release was issued on October 19, 2021.

What type of testing method is SQI Diagnostics moving toward?

SQI Diagnostics is moving toward a trained medical professional collecting fingerstick capillary samples for a convenient COVID-19 antibody test.