Datametrex Obtains Rights to Sell COVID-19 Home Test Kits With FDA Registration
TORONTO, June 16, 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 sell RapiGEN Inc. (“RapiGEN”) COVID-19 home test kitsi. These test kits are FDA registered, suitable for point of care testing, no extra equipment is needed, and are easy to use with results in 5-10 minutes.
If the specimen contains IgM antibodies to SARS-CoV-2, a colored line appears in the T line area. The RapiGen home test kit is a lateral flow immunochromatographic assay (LFIA) for the qualitative detection of IgG antibodies to COVID19 in blood, serum or plasma specimens.Watch the sample video of the test here: https://datametrex.com/investor/video.htmlThe Company’s primary goal is to sell to the current clients for their operations out of Canada, and the Company intends to apply for Health Canada approval with an Interim Order (“IO”).“These test kits are revolutionary in expediting the process of testing since it cuts out the processing time by a fraction, aiding in an earlier detection of the virus, a more accurate prediction of the positive cases and a decrease of the infection rate,” said Marshall, CEO of the Company.“Having seen the urgent need for COVID-19 test kits, Datametrex is doing everything it can to help Canada combat COVID-19 and flatten the curve. In the meantime, having FDA registration under EUA allowing us to help our neighbours to the south and any Canadian company with operations in the US and Europe,” says Andrew Ryu, Chairman 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 test, 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.The Company is exploring oportunities with Michigan Economic Development Corporation and Governor’s Office of Business and Economic Development in California looking into retail, film, healthcare oportunities. With months into the spread of the COVID-19 in Califoria, widespread diagnostic testing still isn’t available. Testing voids, stemming from an overwhelmed supply chain and a disjointed public health system, have hit hardest in California’s rural north. The Michigan Department of Health and Human Services, Michigan State Police, and local health departments are looking to expand COVID-19 testing directly to the community. Michegan now is easing coronavirus restrictions with six-part reopening plan that includes testing to ensure the state lowers the chance of a second wave and to further protect Michigan families.About RapiGEN Inc.
RapiGEN has the manufacturing technology of Gold colloid which is the core material of immunochromatographic assay. RapiGen has developed a convenient, quick and accurate diagnostic kit, focused on developing distinctive next-generation diagnostic kits from existing products. Currently researching and developing various diagnostic kits for increasingly epidemic pathogenesis such as Covid-19, Shigella, Cholera and Entrohemorrhagic E.coli. Additional information on RapiGEN is available at http://rapigen-inc.com/About Food and Drug Aministration 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.About Datametrex
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). 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, the Company provides progressive solutions to support the supply chain. Additional information on Datametrex is available at www.datametrex.com.For further information, please contact:
Marshall Gunter – CEO
Phone: (514) 295-2300
Email: email@example.comNeither 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 StatementsThis 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.i Source: FDA [RAPIGEN INC] – BIOCREDIT COVID-19 IgG+IgM Duo -https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=680769&lpcd=QKO A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5d8342b8-7212-4584-8839-edd666c79914