MedMira reports additional independent performance evaluation results of REVEALCOVID-19™ Total Antibody Test
HALIFAX, Nova Scotia, Oct. 07, 2020 (GLOBE NEWSWIRE) -- Today, MedMira Inc. (MedMira) (TSXV: MIR) announces the results of the latest independent performance evaluation results of REVEALCOVID-19™ Total Antibody Test. The study was carried out at a state licensed, state-of-the-art hospital in Texas (between June and September 2020). This facility utilizes a patient-centred model to provide 24-hour emergency care, short hospital stays, and outpatient services. This opportunity was made possible through our partner Webb Diagnostic Technologies.
Based on fresh blood specimens collected on site, this study was performed to test individuals who came to the clinic for potential SARS-CoV-2 viral infection. A total of 124 blood specimens were tested on site using MedMira’s REVEALCOVID-19™ Total Antibody Test and the results were compared to two EUA approved serological tests. One was the Hangzhou Biotest Biotech Co., Ltd.’s COVID-19 IgG/IgM rapid test and the other was a laboratory-based test, Roche Elecsys’ Anti-Sars-CoV-2 Assay.
Of the 124 blood specimens, REVEALCOVID-19™ Total Antibody Test has showed 100% agreement on 51 SARS-CoV-2 antibody positive blood specimens as confirmed by two reference tests. 73 blood specimens were found to be negative of SARS-CoV-2 antibody by the two reference tests. REVEALCOVID-19™ Total Antibody Test correctly identified 71 of the 73 negative specimens at over 97% specificity.
“STAT Specialty Hospital of Laredo were the first Freestanding Emergency Rooms in Laredo, TX. It is a state licensed, state-of-the art facility that utilizes a patient-centered model to provide 24-hour emergency care, short hospital stays and outpatient services,” said Dr. Mike Chang, physician and managing partner, “I am pleased with the performance of the REVEALCOVID-19™ Total Antibody Test. We found it is simple to perform with instant results in less than 3 minutes and excellent correlation to the two reference tests.”
“We are very pleased to announce this latest independent performance evaluation of our test conducted by this respected hospital where its facility is designed to uniquely respond to the rise in consumer demand for convenience, reduced cost, and improved access to care,” said Hermes Chan, CEO of MedMira Inc. “It is MedMira’s commitment to develop and manufacture near-patient tests, utilizing our patented Rapid Vertical Flow® (RVF) technology, which provides ease of use, immediate results, and performance to meet the end-users expectations. I would also like to thank our trusted partner, Webb Diagnostic Technologies, for helping to find such a reputable testing outlet and for supporting us to conduct this study. During these difficult times, it is a challenge to perform such studies surrounding near-patients. We believe these results will further strengthen our customers trust in the quality of our product”
These independent near-patient testing results obtained directly from end-user shall further strengthen MedMira's claim towards the respective regulators.
MedMira is a leading developer and manufacturer of Rapid Vertical Flow® diagnostics. The Company’s tests provide hospitals, labs, clinics and individuals with instant disease diagnosis, such as HIV and Hepatitis C, in just three easy steps. The Company’s tests are sold globally under the Reveal®, Multiplo® and Miriad® brands. Based on its patented Rapid Vertical Flow® Technology, MedMira’s rapid HIV test is the only one in the world to achieve regulatory approvals in Canada, the United States, China and the European Union. MedMira’s corporate offices and manufacturing facilities are located in Halifax, Nova Scotia, Canada. For more information visit medmira.com. Follow us on Twitter and LinkedIn.
This news release contains forward‐looking statements, which involve risk and uncertainties and reflect the Company’s current expectation regarding future events, including statements regarding possible regulatory approval and launch of the REVEALCOVID-19™ Total Antibody Test, future growth, and new business opportunities. Actual events could materially differ from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the company quarterly filings.
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.
Chief Financial Officer, MedMira Inc.
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