Mississauga-based Microbix, which develops and commercializes proprietary biological products used in diagnostic testing, announced last Thursday it has attained Conformité Européene (CE) marking with the European In-Vitro Diagnostic Devices Directive to sell its SARS-CoV-2 Quality Assessment Products (QAPs) to its distribution network in Europe. MBX has also announced attaining the National Registration with the Italian Ministry of Health.
In the press release, the company said that recently-developed tests for the virus causing COVID-19 disease have been found to be of questionable accuracy, rendering “false negative” or “false positive” results, while the four Microbix SARS-CoV-2 QAPs —which have been shown to work with multiple nucleic-acid test methods used to detect the SARS-CoV-2 virus that causes COVID-19 disease— are aimed at increasing the reliability of nucleic-acid test results.
“We’re pleased to have completed the process of registering our SARS-CoV-2 Controls to permit their sale as controls to clinical labs across the EU,” said Microbix president and CEO Cameron Groome, in the release. “Microbix’s distributors will now engage with European governments, health authorities, hospitals and laboratory chains, to make certain that EU healthcare systems can benefit from these Microbix products.”
Stellick noted MBX’s distribution agreements with 18 EU countries and said the new designations will help with expanding the company’s network.
“MBX announced this morning that it has attained European Union CE Mark Registration for its SARS-CoV-2 Controls. MBX now has presence and the capability to sell its SARS-CoV-2 controls in the United States, Canada and in 18 countries across Europe,” said Stellick.
“The EU CE mark enables the usage of the positive and negative controls for SARS-CoV-2 testing by clinical laboratories across the Company’s network of distributors in 18 EU countries. We believe attaining the CE Mark is extremely positive for the Company given its vast distribution network and we anticipate given the increased traction, MBX will continue to add more countries to its European distributor list,” she wrote.
With the update, Stellick has maintained her “Speculative Buy” rating and $0.50 per share target price, which at press time represented a projected 12-month return of 51.5 per cent.
For the moment, the analyst is leaving her forecast unchanged, calling for fiscal 2020 revenue and EBITDA of $13.6 million and $1.5 million, respectively, and for fiscal 2021 revenue and EBITDA of $15.9 million and $2.7 million, respectively.
Also last week, MBX announced a distribution deal with Alpha-Tec Systems to provide distribution, sales and marketing and technical support for QAPs, while on May 27, the company announced the build-out of a second facility to support a tenfold increase in production capacity for its QAPs products.
According to the company, the initial phase will cost $0.825 million and will be completed by August of this year.
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