The desire to have an accurate test that can detect the extremely virulent Omicron variant of the COVID-19 virus may provide an opening for a Halifax biotechnology company eager to crack the U.S. market.
MedMira Inc. is hopeful about finding a partner in the United States that would help open the door to selling its proprietary rapid vertical flow technology to test saliva samples for Omicron.
Late last year, MedMira announced the expansion of its product line with the launch of its VYRA CoV2Flu rapid antigen test device. Based on MedMira’s technology, the three-in-one test can simultaneously detect SARS-CoV-2 (COVID-19) and influenza A and B, said longtime MedMira CEO Hermes Chan in an interview.
The system allows the three results to be achieved with just one sample in less than three minutes.
MedMira’s manufacturing facilities in Halifax are subject to quality system regulations and periodic inspections by the U.S. Food and Drug Administration and other standards organizations. Chan said the lab recently had its FDA approval renewed, has been fully certified and received all necessary licences and certificates, such as the FDA establishment licence, ISO and medical device single audit program certification.
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The company had its technology approved for an American risk-based classification that allows the marketing of novel medical devices. The designation indicates reasonable assurance of safety and effectiveness.
MedMira has applied to take advantage of clearance processes and to market its technology in the United States.
It is also seeking “Conformit Europene” marking for VYRA CoV2Flu tests in Europe. MedMira has indicated it plans to first launch the COVID testing product there, together with its REVEALCOVID-19 product line, and subsequently launch VYRA CoV2Flu in the United States