Datametrex Secures Exclusive Rights to Distribute FDA, EUA and CE Approved COVID-19 Saliva Kit
Toronto, Ontario--(Newsfile Corp. - February 3, 2021) - Datametrex AI Limited (TSXV: DM) (FSE: D4G) (OTC Pink: DTMXF) (the "Company" or "Datametrex") is pleased to announce that it has secured exclusive rights to sell and distribute COVID-19 saliva kit manufactured by WIZCHEM CO., LTD. ("WIZCHEM") in Canada and Saudi Arabia, and non-exclusive rights for the United States of America, United Kingdom, and European Unions.
The Company signed the distribution agreement on January 28, 2021, to sell the COVICHEK™ Saliva DNA/RNA Collection Kit and COVICHEK™ Viral Transport Medium (together "COVICHEK™") in Canada, United States, European Union, United Kingdom, and the Kingdom of Saud Arabia. The Company did not pay any consideration to the manufacturer to obtain sales rights.
COVICHEK™ Saliva Kit is a convenient DNA and RNA saliva collection device that stabilizes DNA and RNA long term in saliva sample. The saliva collection tube clearly indicates the volume of saliva required after which the funnel is removed, and cap replaced. The device is fully specified for sample transport and storage.
WIZCHEM has secured U.S. FDA EUA, CE mark certification, and is Good Manufacturing Practice (GMP) facilities compliant. These tests are manufactured the with permission from the Korean FDA based on ISO 13485, and sold globally. Each of the manufacturers' medical devices will be submitted to Health Canada ("HC") for approval on a fast track basis and, until such approval is granted, these tests may not be sold or used in Canada at this time.
Each of the manufacturers' medical devices will be submitted to Saudi Food & Drug Authority ("SFDA") for the Kingdom of Saudi Arabia for approval on a fast track basis.
"Datametrex has been awarded another incredible opportunity to secure an additional medical testing device supplier from South Korea with WIZCHEM. With the second wave of COVID-19 in the United States and throughout the world, we at Datametrex believes an increase in testing capacity is critical to test, track and protect populations," said Marshall Gunter, CEO of Datametrex AI Limited.
The Company's ability to fulfill any purchase order for the COVICHEK™ test kits is subject to the availability of inventory at the time of order. Due to the extraordinarily high demand for COVID-19 test, there is volatility in the supply chain and available supply may fluctuate on a daily basis.
The following certifications have been awarded for the COVICHEK™:
- The U.S. Food & Drug Administration ("FDA") approved under Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices ("EUA") for the United States.
- CE marking certification for European Economic Area ("EEA") countries, which covers the 26 member states of the EU, the 3 members of EFTA, plus Turkey and the United Kingdom under Brexit.
Benefit of Saliva Collection Kits
Saliva collection is easier to perform and less discomfort than taking a sample with a swab deep into the nasal cavity or throat. Because Medical workers do not need to collect samples separately, they can reduce their risk of disease infection. Saliva collection is faster and more scalable than swab collection, which can increase the number of people inspected each day. Also, saliva collection is painless and easy for use in remote areas, suitable for on-site, home and clinic based sampling.
Since its establishment in 2008, WIZCHEM has been researching, developing, and producing products with global competitiveness to meet customer needs in various fields such as functional chemical materials, biomedical cosmetics, hydrogel wound dressing and medical care. Based on these accumulated technologies, for testing various viruses such as coronavirus, we have recently developed and produced in vitro diagnostic products such as viral transport medium (VTM) and swabs that collect and transport infectious virus samples, also viral DNA/RNA extraction kit and saliva collection kit for rapid and accurate diagnosis of diseases.
For additional information on WIZCHEM and other corporate information, please visit the Company's website at www.wizchem.com.
About CE Marking
CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). The CE marking is also found on products sold outside the EEA that have been manufactured to EEA standards. This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area (the 26 member states of the EU, the 3 members of European Free Trade Association ("EFTA"), plus Turkey and United Kingdom). CE marking also supports fair competition by holding all companies accountable to the same rules. For more information, please consult the European Commission website at: CE marking
About Food and Drug Administration EUA
On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary of HHS then declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 subject to the terms of any authorization issued under Section 564(a) of the Act.
Datametrex AI Limited is a technology-focused with exposure to Artificial Intelligence and Machine Learning through its wholly-owned subsidiary, Nexalogy (www.nexalogy.com). Datametrex's mission is to provide tools that support companies in fulfilling their operational goals, including Health and Safety, with predictive and preventive technologies. By working with companies to set a new standard of protocols through Artificial Intelligence and health diagnostics, Company provides progressive solutions to support the supply chain.
For additional information on Datametrex and other corporate information, please visit the Company's website at www.datametrex.com.
For further information, please contact:
Marshall Gunter - CEO
Phone: (514) 295-2300
Neither the TSX Venture Exchange nor it's 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.
Forward Looking Statements:
All statements included in this press release that address activities, events, or developments that the Company expects, believes, or anticipates will or may occur in the future are forward-looking statements. These forward-looking statements involve numerous assumptions made by the Company based on its experience, perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate in the circumstances. In addition, these statements involve substantial known and unknown risks and uncertainties that contribute to the possibility that the predictions, forecasts, projections, and other forward-looking statements will prove inaccurate, certain of which are beyond the Company's control. In particular, there is no guarantee that the parties will successfully negotiate and enter into a definitive agreement on mutually acceptable terms or complete the Transaction in the manner contemplated herein, if at all, that the due diligence of any of the parties will be satisfactory, or that the parties will obtain any required board, shareholder, third-party and/or regulatory or other governmental approvals, if any. Readers should not place undue reliance on forward-looking statements. Except as required by law, the Company does not undertake to revise or update these forward-looking statements after the date hereof or revise them to reflect the occurrence of future unanticipated events.
CovichekTM Saliva Collection Kit
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