RE:News : health Canada Datametrex Applies to Health Canada for 5 Minute Fast Antigen Kit
TORONTO, Sept. 01, 2020 (GLOBE NEWSWIRE) -- 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 – CEO
Phone: (514) 295-2300
Email: mgunter@datametrex.com