TORONTO, May 11, 2020 (GLOBE NEWSWIRE) -- Datametrex AI Limited (the “Company” or “Datametrex”) (TSXV: DM, FSE: D4G, OTC: DTMXF) is pleased to announce that it has secured non-exclusive rights to COVID-19 test kits with Health Canada (“HC”) approval, Kingdom of Saudi Arabia, Saudi Food & Drug Authority (“SFDA”) approval, and CE marking certification (“CE”) for European Economic Area (“EEA”) countries, which covers the 27 member states of the EU, the 4 members of EFTA, plus Turkey and the United Kingdom under Brexit.
The latest, and fourth kit to be added by Datametrex to distribute is the 1copy™ COVID-19 qPCR Multi Kit (“qPCR kit”), which is Health Canada approved with Authorization Reference Number 312777, Device ID 1020660 and Model No. M22MD100. It is a nucleic test kit providing results in less than two hours that verifies the RdRp gene for SARS-CoV-2 with real-time qPCR kit via a nasopharyngeal swab and oropharyngeal swab, specifically targeting the E gene sequences of COVID-19. The kits are made by 1drop Inc. (“1drop”) in South Korea, and are immediately ready for sales orders in Canada.
1drop is located in South Korea and is a medical technology spin-off from Samsung Electronic’s C-Lab program. The C-Lab is an internal incubation program within Samsung that first started in 2012 to help inspire a more creative company culture. 1drop already has more than five products approved in Europe in the past 18 month under the CE marking certification. “CBC News reported that Canada lost almost two million jobs during the month of April as the impact of COVID-19 according to Stats Canada’s release on May 8, 2020. The team has been working around the clock to identify and source high quality test kits from South Korea for Canada. We are thrilled to have secured the rights to sell kits from 1drop, Health Canada approved manufacturer. We will be able to start filling orders immediately and are looking forward to help flatten the curve and get Canadians back to work safely,” says Marshall Gunter, CEO of the Company.
The Company’s ability to fulfill any purchase order for COVID-19 test kits is subject to the availability of inventory at the time of order. Due to the extraordinarily high demand for COVID-19 tests, there is volatility in the supply chain, and available supply may fluctuate on a daily basis.
Datametrex anticipates that it will have little or no upfront costs associated with importing and selling these test kits. Assuming these test kits are purchased by the Canadian Government, the manufacturer will ship the test kits directly to the Canadian government or hospitals, and Datametrex will not be involved in the shipping, warehousing, or distribution process.
The Company did not pay consideration to the manufacturer to obtain sales rights.
The Company granted 16,500,000 incentive stock options to its directors, officers, employees and consultants in accordance with the Company's Stock Option Plan. These stock options have an exercise price of $0.17 and expire on June 30, 2022. All options will be subject to a vesting schedule, with 25% immediately vesting and 25% vesting on the three, six and nine month anniversaries of the grant date.
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 27 member states of the EU, the 4 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 Kingdom of Saudi Arabia, Saudi Food & Drug Authority (“SFDA”)
The Saudi Food & Drug Authority (SFDA) is the government agency that regulates drugs and medical devices in Saudi Arabia. It is also in charge of biological and chemical substances, as well as electronic products. The agency was established under the Council of Ministers and functions under the Council of Ministers as an independent body that reports to the President of Council of Ministers.
SFDA is in charge of overseeing the safety, security and effectiveness of medical devices, ensuring their accuracy, and controlling and supervising manufacturing facilities, as well as overseeing the importation and registration of these products.
A list of regulations can be found here on SFDA website.
About 1drop Inc.
1drop is located in Jungwon-gu, South Korea, and was incorporated in 2017 following a technology spin-off from Samsung Electronic’s C-Lab program. Samsung Electronic’s C-Lab, located in South Korea is an internal incubation program that first started in 2012 to help inspire a more creative company culture. 1drop already had more than five products approved in Europe in the past 18 month under CE marking is a certification.
For more information please consult the website at: 1drop
Datametrex AI Limited is a technology focused company with exposure to Artificial Intelligence and Machine Learning through its wholly owned subsidiary, Nexalogy (www.nexalogy.com). Additional information on Datametrex is available at www.datametrex.com
For further information, please contact:
Marshall Gunter – CEO
Phone: (514) 295-2300
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This news release contains “forward-looking information” within the meaning of applicable securities laws. All statements contained herein that are not clearly historical in nature may constitute forward-looking information. In some cases, forward-looking information can be identified by words or phrases such as “may”, “will”, “expect”, “likely”, “should”, “would”, “plan”, “anticipate”, “intend”, “potential”, “proposed”, “estimate”, “believe” or the negative of these terms, or other similar words, expressions and grammatical variations thereof, or statements that certain events or conditions “may” or “will” happen, or by discussions of strategy.
Readers are cautioned to consider these and other factors, uncertainties and potential events carefully and not to put undue reliance on forward-looking information. The forward-looking information contained herein is made as of the date of this press release and is based on the beliefs, estimates, expectations and opinions of management on the date such forward-looking information is made. The Company undertakes no obligation to update or revise any forward-looking information, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.