MBX.TO -- Attains Health Canada License for COVID-19 Testing

Microbix Attains Health Canada Establishment Licensing

MISSISSAUGA, Ontario, April 21, 2020 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, Microbix®), a life sciences innovator and exporter, announces that it has attained medical devices establishment licensing from Health Canada, enabling the immediate usage of its quality assessment products (QAPs™) by clinical laboratories, including its QAPs to help ensure the accuracy of COVID-19 disease testing.

It has been widely reported that the recently-deployed tests for the virus causing COVID-19 disease are providing results of questionable accuracy – sometimes giving “false negative,” or “false positive” results. Microbix’s QAPs are designed to increase the reliability of test results and this licensing from Health Canada will allow their use in testing labs across the country.

At present, Microbix has capacity to make 5,000 units per week of room-temperature stable COVID-19 QAPs exclusively on COPAN® FLOQSwabs®, and 10,000 units per week in a liquid vial format. Such QAPs can be shipped as early as April 30 to support the verification of new testing methods, the validation of newly-placed test instruments, training of technicians, lab proficiency accreditations, and by clinical labs for systematic quality control. By way of example, at usage of one per hundred tests, such QAPs can help ensure the accuracy of 1.5 million COVID-19 tests per week.

Cameron Groome, President and CEO , stated, “We thank Health Canada for its review and acceptance of the application provided by Microbix on April 13th. Such prompt action is precisely what is needed to get leading-edge tools like Microbix’s QAPs into the hands of Canada’s front-line healthcare providers. Microbix will now engage with procurement authorities in Ontario and other provinces and territories to make certain that Canadians can benefit from Microbix’s products that help to ensure test accuracy.”

The Microbix COVID-19 QAPs have been shown to work with multiple nucleic-acid based test ( NAT ) methods used to detect the SARS-CoV-2 virus that causes COVID-19 disease, specifically those targeting E, N, and RdRP genes, and on protocols requiring human RP housekeeping gene presence. These Microbix products are being made available as REDx™FLOQ® SARS-CoV-2 for swabs, and as REDx™ SARS-CoV-2 for liquid aliquots.

As for all Microbix QAPs, these COVID-19 QAPs are whole-genome workflow support tools that include 100% of the genetic sequences of the virus and emulate real patient samples while being consistent, non-infectious, and stable. As such, the COVID-19 QAPs contain all possible NAT viral targets – ensuring compatibility across current and future NATs. This broad compatibility and guaranteed utility is particularly relevant in the context of testing during a pandemic, when multiple test protocols and instrument systems are being newly-called into use.

Microbix supplies a broad range of white-labeled QAPs, including other viral respiratory pathogens, to support the proficiency testing (PT) programs of laboratory accreditation organizations in North America and Western Europe. Under its PROCEEDx™ brand, Microbix provides RUO (research-use-only) QAPs to support the test validation/verification and operator training objectives of test developers and clinical labs. Full QMS support of clinical laboratory patient sample testing is provided by Microbix’s Health Canada licensed, FDA registered, and CE mark certified REDx™ Controls or REDx™FLOQ® brand QAPs.

About Microbix Biosystems
Microbix develops proprietary biological and technology solutions for human health and well-being, with approximately 80 skilled employees and sales now usually exceeding $1 million per month on average. It makes a wide range of critical biological materials for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure quality control of clinical diagnostic tests. Microbix antigens and QAPs are sold to many customers worldwide, at present primarily to multinational diagnostics companies and laboratory accreditation organizations.

Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots.

Microbix is a publicly-traded company, listed on the Toronto Stock Exchange and headquartered in Mississauga, Ontario, Canada.
Comment: It's worth noting that Microbix is a far more established company compared to recently hyped up Biomed stocks that ran on Coronavirus related news.

The company has 80+ employees and generates monthly revenue in excess of $1M. Here are some highlights from 2019 yearly financials...

Management Discussion

In 2019, Microbix advanced upon its goal of sustained profitability, achieving record sales of $13.4 million and improving its gross margin, operating earnings and cash provided by operations.

For fiscal 2020, further sales growth and continuing improvements to gross and net margins are expected. Microbix remains committed to improving its operational and financial strength and thereby driving share price appreciation.

12 Month Financial Results

2019 full-year revenue was $13,412,341, a 7% increase from 2018 revenue of $12,510,558. Included were antigen and quality product revenues of $13,067,727, 7% higher than 2018. Sales were strong across multiple customers in North America and Europe and several of our key products. Revenue from royalties were $344,614 (2018 - $319,201).

Percentage gross margin for 2019 was 49%, up from 43% in 2018, with the improvement due to resolution of yield control issues and favourable changes to product mix.

Operating expenses increased by 6% in 2019, primarily a result of increased investment in sales and marketing and $135,000 of financing expenses which had been capitalized in prior years. In 2019, stronger sales and gross margins led to an operating income of $43,681 versus an operating loss of $742,808 in 2018, and a net income of $31,918 versus a net loss of $8,621,566 in 2018 (that included an asset write-down). Cash provided by operations (“CFO”) was $44,368 in 2019, compared to cash used of $537,005 the prior year.
Comment: Microbix Announces Quality Products Distribution Agreement

ISSISSAUGA, Ontario, April 27, 2020 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, Microbix®), an award-winning life sciences innovator and exporter, announces the appointment of Labquality Oy (Labquality) as a distributor of its Quality Assessment Products (QAPs™) in seven (7) countries.

Under an agreement between the parties, Labquality has been appointed as distributor of Microbix’s quality assessment products (QAPs™) for Denmark, Estonia, Finland, Latvia, Lithuania, Poland, and Sweden. As distributor, Labquality will provide marketing, distribution, and logistical support for Microbix’s QAPs. At present, there are four dozen such QAPs across the PROCEEDx™ and REDx™ Controls tradenames – to support whole-process accuracy of tests for bacterial and viral diseases by emulating patient samples while being consistent, non-infectious, stable, and cross-instrument compatible.

Based in Helsinki, Labquality is a Finnish owned and operated life sciences company that provides clinical laboratories with external quality assessment (EQA) programs to evaluate their proficiency and attain necessary accreditations. Labquality also provides quality controls (e.g., QAPs) and other reference materials to support the internal quality management systems of clinical laboratories. Labquality services approximately 6,500 customers in over 50 countries and maintains an extensive network of sub-distributors of its products and programs.

Labquality will incorporate Microbix’s QAPs into its EQA programs and sell PROCEEDx and REDx Controls branded QAPs directly to its clinical laboratory customers. This will include Microbix’s QAPs to support the accuracy of testing for respiratory viruses such as SARS-CoV-2 (COVID-19), Flu A, Flu B, and RSV, as well as its leading-edge QAPs for high-risk types of HPV and other sexually-transmitted infections. Labquality already services clinical labs in the territories and is well-positioned to distribute the full QAPs catalogue.

Cameron Groome, CEO & President of Microbix, stated, “We’re pleased to have Labquality become our distribution partner for QAPs product lines for Scandinavia and Northern Europe. As an established proficiency testing program provider and product distributor in the region, they are highly-respected and well-known by both hospital and stand-alone labs. Our controls are therefore a natural addition to their product offerings and we are convinced the agreement will be successful for both our companies.”

Mia Lindström, Managing Director of Labquality, also commented, “We’re pleased to secure access to Microbix’s innovative QAPs for our laboratory customers. There is an ever-increasing need to improve the accuracy of clinical diagnostic testing that these products will help address. Training of Labquality staff about QAPs is already well advanced and we are now beginning to stock this product portfolio.”


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