Datametrex AI Limited (the
“
Company” or “
Datametrex”)
(
TSXV: DM, FSE: D4G, OTC: DTMXF )
is pleased to announce that the Company has submitted a Medical
Devices Interim Order
(“IO”) Request Form to
approve PCL, Inc.’s (
“PCL”) COV05 COVID19 Rapid
Antigen Detection Kits to Health Canada.
This application is made under IO Respecting the
Importation and Sale of Medical Devices for Use in Relation to
COVID-19 pursuant to subsection 30.1(1) of the Food and Drugs Act
signed by the Minister of Health on August 24, 2020, for PCLCOV05
COVID19 Rapid Antigen Detection Kits. This IO will allow Health
Canada to issue expedited review and approval for the sale of these
test kits in Canada.
The Company has represented to Health Canada
that it will be able to provide a minimum first order of 200,000,
followed by an additional 200,000 units on a weekly basis. Any
purchase of the test kits by the Canadian government is conditional
on prior receipt of Health Canada approval.
These test kits are suitable for point of care
tests. No extra equipment is needed. They are simple to use and
results are available in 10 minutes.
"According to the manufacturer, PCL, this test
can detect antigens of COVID-19 from a swab in the nose and throat
to provide results in 5-10 minutes with over 86% accuracy," said
Marshall Gunter, CEO of Datametrex. “These almost-instant kits can
be easily used at home. With the rise of cases in the United States
and throughout the world, we at Datametrex believe it is critical
to test and protect.”
View the PCL Antigen test manual video by
clicking the link: PCL COVID-19 ANTIBODY TEST - COV0
According to PCL the clinical sensitivity
(confirmed the actual positive of the approved person where
approved person tested positive with a PCR nucleic test) is 86.49%
and the clinical specificity (confirmed the actual negative of the
negative person where the negative person tested negative with a
PCR nucleic test) is 97.87%*. Early detection using rapid tests
will also provide further protection to Canada’s front-line
workers, especially health care professionals.
The following certifications have been awarded
to these PCL Antigen Test Kits: CE Certificate, Korea KPMG, FIND
Listed, UNGM Supplier. Countries includes the EU, 2 countries in
the Middle East- Qatar and UAE, India, Russia, 3 countries in Latin
America- Guatemala, Ecuador, and Colombia.
The PCL Inc Antigen Detection kit has the
CE Certificate meaning that the manufacturer
and products have met EU declaration of standards for health,
safety, and environmental protection, allowing this product to be
sold within the 22 countries in the European Economic Area.
Health Canada must approve these COVID-19 test
kits before they can be used in Canada. The Company plans to sell
these kits in all countries where the kits have been approved for
sale. Datametrex anticipates that it will have little or no upfront
costs associated with importing these test kits. Assuming Health
Canada approves the test kits and they are subsequently purchased
by the Canadian government, 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.
* Clinical Accuracy
The clinical performance of the PCL COVID-19 Ag
Rapid FIA was evaluated in two different institutions compared to
RT-PCR positive cases. Positive percent is 86.49% (95% CI:
70.43-94.92%) and negative percent agreement is 97.87% (95% CI:
87.28%-99.89%) in the PCL COVID-19 Ag Ripid FIA.
COVID-19 Ag Ripid FIA. |
RT - PCR |
PPA (%) |
NPA (%) |
POS |
NEG |
Site 1 |
POS |
20 |
0 |
100.00 |
96.00 |
NEG |
0 |
20 |
Total |
20 |
20 |
Site 2 |
POS |
12 |
1 |
70.59 |
100.00 |
NEG |
5 |
26 |
Total |
17 |
27 |
Total |
POS |
32 |
1 |
86.49 |
97.87 |
NEG |
5 |
46 |
Total |
37 |
47 |
About Datametrex
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. 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 historical 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 time such
forward-looking information is made. 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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