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 COVID-19
test kits from two additional South Korean manufacturers, including
a kit that is U.S. Food & Drug Administration
(
“FDA”) approved under Coronavirus Disease 2019
(COVID-19) Emergency Use Authorizations for Medical Devices
(
“EUA”) for the United States, 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.
According to each of the manufacturers, these
test kits made are both Nucleic Acid based, which Health Canada is
prioritizing the review of. Each of the manufacturers’ test kits
have been submitted to Health Canada approval on a fast track basis
and, until such approval is granted, these tests may not be sold or
used in Canada. The Company is currently working closely with
Health Canada to have the approval of the test kits fast tracked.
An Interim Order Request for Health Canada has been submitted for
300,000 kits immediately and an additional 100,000 weekly
thereafter.
One of the test kits, manufactured by Seasun
Biomaterials (“Seasun”) Inc. of South Korea,
was authorized on April 27, 2020 by the FDA in the United
States for Emergency Use under the EUA by
authorized laboratories and has also been approved for
use in the EEA with CE marking certification. 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.
Seasun claims that the average number of
specimens that can be tested in a 12 hour period with their U-TOP
COVID-19 Real-Time Detection Kit is 3,400. Seasun advises this is
the equivalent of approximately 283 tests per hour, and the
kit uses dual-labeled peptide nucleic acid probes to detect two
distinct regions in ORF1ab and one region in N gene of the
SARS-CoV-2 genome in oropharyngeal and nasopharyngeal swab
specimens, anterior nasal and mid-turbinate nasal swabs,
nasopharyngeal wash/aspirate or nasal aspirate specimens, and
sputum. The test runs on any authorized RT-PCR instrument and can
be performed by any lab CLIA-certified to perform high-complexity
tests.
Seasun is an in vitro diagnostic
company that develops molecular diagnostic platforms of infection
diseases, cancer as well as genetic and epigenetic disorders.
Seasun develops and commercializes innovative real-time PCR-based
diagnostic platforms through the development of its proprietary
technologies to provide more advanced molecular diagnostic
services. Seasun’s test kits will be distributed by its third party
distributor, which Datametrex has agreements in place with for
distribution globally. The other manufacturer that Datametrex has
obtained sales rights from has requested not to be named publicly
at this time.
The Company announced on April 21, 2020 the
appointments of Dr. Joseph Curtis and Dr. Lisa Palleson-Stallan to
the advisory board in anticipation of securing US FDA EUA approval
on the test kits. Selling into the US market requires
infrastructure and a qualified contact person that can assist not
only in identifying opportunities to sell the test kits but also
with the compliance requirements. The Company is continuing to work
with Health Canada with respect to the application for approval of
previously announced iONEBIO Inc. COVID-19 test kits.
“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 and Europe,”
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 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. Assuming Health Canada
approves the test kits and they are subsequently 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 either
of the manufacturers to obtain sales rights. Seasun’s application
to have its test approved by Health Canada were submitted directly
by Seasun, while Datametrex submitted an application for approval
with respect to the other manufacturer’s tests.
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 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). Additional information on Datametrex is
available at www.datametrex.com.
For further information, please
contact:
Marshall Gunter – CEOPhone: (514) 295-2300Email:
mgunter@datametrex.com
Jeff Stevens – AdvisorPhone: (647)
400-8494Email: jstevens@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.
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