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.
Two Covid-19 test kits distributed by Datametrex granted FDA emergency use authorisation. (Credit: PIRO4D from Pixabay)
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.
Source: Company Press Release