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
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.
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.
Source: Company Press Release