Datametrex AI Limited (the
"
Company" or "
Datametrex")
(
TSXV: DM, FSE: D4G, OTC: DTMXF) is pleased to
announce that Seasun Biomaterial’s 20 minute rapid Nucleic Acid
test kit, AQ-TOP COVID-19 Rapid Detection Kit, has received
authorization from the U.S. Food & Drug Administration
(
“FDA”) registered under the Coronavirus Disease
2019 (COVID-19) Emergency Use Authorizations for Medical Devices
(
“EUA”).
“These test kits can expedite the process of
testing by reducing testing times, 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 Gunter, CEO of the
Company.
Additionally Datametrex would like to provide an
update on the 1drop Inc. (“1drop”) test kits. The
1copy™ COVID-19 qPCR Multi Kit has secured FDA authorization under
the EUA. This 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 kits via a nasopharyngeal swab and oropharyngeal swab,
specifically targeting the E gene sequences of COVID-19.
So far, Datametrex has a total of three (3) test
kits that are FDA approved under Coronavirus Disease 2019
(COVID-19) Emergency Use Authorizations for Medical Devices
(“EUA”) available for sale. The approved test kits
are 1copy™ COVID-19 qPCR Multi kit, Seasun U-TOP™ COVID 19
Detection Kit, and AQ-TOP COVID-19 Rapid Detection Kit.
"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 under
EUA approved test kits allow us to help our neighbours to the south
and any Canadian company with operations in the US," says Marshall
Gunter, CEO of the Company.
With regard to the FDA authorization: (1) this test has not been
FDA cleared or approved; (2) this test has been authorized by the
FDA only for the detection of nucleic acid from SARS-CoV-2, not for
any other viruses or pathogens; and (3) this test is only
authorized for the duration of the declaration that
circumstances exist justifying the authorization of emergency
use of in vitro diagnostics for detection and/or diagnosis of
COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. §
360bbb-3(b)(1), unless the authorization is terminated or
revoked sooner.
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.
About Seasun Biomaterials
Seasun Biomaterials Inc. (“Seasun”) of South
Korea is an in vitro diagnostic company that develops
molecular diagnostic platforms of infection diseases, cancer as
well as genetic and epigenetic disorders. Developing and
commercializing innovative real-time PCR-based diagnostic platforms
through the development of our proprietary technologies to provide
more advanced molecular diagnostic services. Additional information
on Seasun is available at www.seasunbio.com
About 1drop Inc.
1drop Inc. aims to provide a solution to manage
health with a drop of fluid. It has the key technologies for
becoming a global leading company in the field of smart health
care. 1copy™ COVID-19 qPCR Multi Kit can reduce the risk of
asymptomatic and latent infection of COVID-19 by a single virus
level limit of detection. It 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 months under the CE marking certification.
The team has been working around the clock to identify and source
high quality test kits from South Korea for Canada. Additional
information on 1drop Inc. is available at www.1drop.co.kr
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.
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 – CEOPhone: (514)
295-2300Email: mgunter@datametrex.com
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
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.
DataMetrex AI (TSXV:DM)
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