New York State Approves SQI Diagnostics' EXACT COVID-19 Antibody Assay
SQI Diagnostics Inc. announced conditional approval from the New York State Department of Health for its EXACT COVID-19 Antibody Test. This test can identify antibodies in vaccinated individuals and those previously infected with COVID-19. It provides semi-quantitative measurements from a small blood sample collected via fingerstick and is available through partner AZOVA Inc.. The test aims to enhance COVID-19 response strategies by offering insights into antibody levels and their correlation with breakthrough infections.
- Conditional approval from New York State enhances credibility and market presence.
- EXACT COVID-19 Antibody Test offers semi-quantitative measurement of antibodies.
- Test can be conducted easily via home or office settings.
- Partnership with AZOVA expands access to healthcare services in the U.S.
- None.
-- Conditional Approval Makes Quick, Precise Test for Presence of Antibodies to
SARS-CoV-2 Available in the US --
TORONTO, March 3, 2022 /PRNewswire/ - SQI Diagnostics Inc. ("SQI" or the "Company") (TSXV: SQD) (OTCQB: SQIDF), leaders in the science of lung health, announced today that New York State Department of Health (NYSDOH) has given conditional approval to its diagnostic testing partner, KSL Diagnostics, Inc. in Buffalo NY, for the EXACT COVID-19 Antibody Test.
"The EXACT COVID-19 Antibody Test is the next generation of tools in the fight against COVID-19. It gives peace of mind because it can detect an immune response in both vaccinated and previously COVID-19 infected people. It also has the potential to give the health care system key insights and data into the relationship between antibody levels and breakthrough infections and reinfections," says Andrew Morris, CEO of SQI Diagnostics. "We're bringing these tests to market now because we are determined to do our part to end the pandemic."
NYSDOH, under the Clinical Laboratory Evaluation Program, evaluates and authorizes lab-developed tests for use in New York State certified clinical laboratories, which are subject to requirements equal to or more stringent than the Clinical Laboratory Improvement Amendments of 1988 (CLIA). "KSL is proud to partner with SQI in delivering this test and is licensed to test specimens from anywhere in the United States," says Kevin Lawson, President and CEO of KSL.
Access to the EXACT COVID-19 Antibody Test will now be available to physicians and their patients in the United States through AZOVA Inc, a telemedicine testing company that makes healthcare accessible and affordable to Americans through innovative solutions.
The EXACT COVID-19 Antibody Test is an advanced COVID-19 antibody test that provides semi-quantitative measurements of six distinct antibodies produced by the immune system in response to exposure to the SARS CoV-2 virus or to COVID-19 vaccination. The small volume blood sample can be collected in a home or office setting with a fingerstick. A positive test result could indicate the presence of antibodies arising from a prior COVID-19 infection or COVID-19 vaccination.
"The EXACT COVID-19 Antibody Test is a key part of SQI's growing ability to offer unparalleled clinical insight through varied and improved COVID-19 testing," said Morris. "We currently sell Health Canada-approved testing kits for SARS-CoV-2 RT-PCR molecular testing and point of care antigen testing products, which enable rapid serial testing of asymptomatic populations. We have also filed with Health Canada — for review under the Interim Order —SQI's RALI-Dx IL-6 test, a hospital-based respiratory triage test for COVID-19 positive patients."
About SQI Diagnostics
SQI Diagnostics are leaders in the science of lung health. We develop and manufacture respiratory health and precision medicine tests that run on SQI's fully automated systems. Our tests simplify and improve COVID19 antibody monitoring, Rapid Acute Lung Injury testing, donor organ transplant informatics, and immunological protein and antibody testing. We're driven to create and market life-saving testing technologies that help more people in more places live longer, healthier lives. For more information, please visit www.sqidiagnostics.com.
About AZOVA
AZOVA is a globally connected Digital Health System providing telehealth and digital health services through globally connected provider, pharmacy, and laboratory networks. AZOVA provides innovative COVID testing and vaccination solutions for employers, schools, government entities, airlines, the travel industry, and the consumer. AZOVA has created the world's first truly connected global laboratory network to enable travelers to access COVID testing anywhere in the world. For more information, visit azova.com.
About KSL Diagnostics
KSL (www.ksldx.com) operates New York State Department of Health / CLIA certified clinical laboratories licensed throughout the US, including Beutner Laboratories and the Robert Guthrie Laboratory. The rapidly expanding menu integrates standard of care tests and novel assays, developed at KSL and through partnership with innovative diagnostic companies. KSL provides superlative regulatory compliance and industry-leading standards of service.
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.
View original content to download multimedia:https://www.prnewswire.com/news-releases/new-york-state-approves-sqi-diagnostics-exact-covid-19-antibody-assay-301495051.html
SOURCE SQI Diagnostics Inc.
FAQ
What is the significance of the New York State approval for SQI Diagnostics?
What can the EXACT COVID-19 Antibody Test detect?
How is the EXACT COVID-19 Antibody Test administered?
Who can access the EXACT COVID-19 Antibody Test?
What is the role of AZOVA in this approval?
