Vancouver, British Columbia – TheNewswire – August 4, 2020 – Blackhawk Growth Corp. (CSE:BLR) (CNSX:BLR.CN) (OTC:BLRZF) (the “Corporation” or “Blackhawk“), is pleased to announce that it has entered into a Memorandum of Understanding (the “MOU“), dated effective August 3, 2020, with Medigen Biotechnology Corporation (“MBC“) and its affiliate company, TBG Biotechnology Corp. (“TBG“) to distribute an ExProbe SARS-CoV-2 Testing Kit and a SARS-CoV-2 IgG/IgM Rapid Test Kit (collectively, the “Test Kits“) used in the detection of antibodies associated with COVID-19.
The MOU contemplates that Blackhawk will be granted the non-exclusive right to distribute the Test Kits in North and South America, including Canada and the United States. The ExProbe SARS-CoV-2 Testing Kit has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for use in the United States by authorized laboratories, as of June 10, 2020, and the SARS-CoV-2 IgG/IgM Rapid Test Kit has been listed by the FDA, under the Emergency Use Authorization (EUA) for use in the United States by authorized laboratories as of May 6, 2020.
While the sale of both the ExProbe SARS CoV-2 Testing Kit and the SARS CoV-2 lgG/lgM Rapid Test is permitted in the United States, neither of the Test Kits have been approved by Health Canada. Blackhawk intends to submit the Test Kits for Health Canada approval once a final agreement has been negotiated with MBC and TBG. There can be no guarantee that Health Canada approval will be received once an application is completed.
Both MBC and TBG have committed to supporting Blackhawk’s efforts to obtain and maintain all necessary certifications and approvals for the sale and marketing of the Test Kits in Canada by granting access to all necessary documentation and studies concerning the Test Kits. Once Health Canada approval is granted, Blackhawk would be the exclusive and sole distributor in Canada provided minimum order and sales levels are maintained.
The following information has been provided to Blackhawk directly from MBC and TBG:
ExProbe SARS-CoV-2 Testing Kit
TBG offers a high throughput automatic NAT workstation for a total PCR solution.
Real Time PCR Nucleic Acid Test (NAT) – is the standard for detection of any unknown species and is the most precise test for COVID-19 confirmation, and the sensitivity of the ExProbe SARS-CoV-2 Testing Kit is second in the market:
PERFORMANCE SPECIFICATION – PCR TESTING
The testing kit serves only as an auxiliary diagnosis method in a laboratory or hospital. During transportation reagents must be kept frozen at low temperature (-20 degrees C). Reagents are subject to moisture and heat, and therefore should be immediately used for tests after unpacking.
SARS-CoV-2 IgG/IgM Rapid Test Kit – confirms the presence of antibodies associated with COVID-19.
PERFORMANCE SPECIFICATION – RAPID TEST KIT
Click Image To View Full Size
SENSITIVITY – measures how often a test correctly gives a positive result when a person has the disease.
SPECIFICITY – measures how often a test gives a negative result when a person does not have the disease.
SARS-CoV-2 IgG/IgM Rapid Test Kit has an overall accuracy rate of 99.49% (Sensitivity: 98.04% / Specificity: 99.80%).
“With the ever-changing technological landscape in the testing space it was important for us to stay ahead” says Frederick Pels, CEO of Blackhawk. “The United States is obviously a significant market so a PCR test with emergency use authorization and another rapid antibody test listed by the FDA only increases our ability to close more deals and penetrate what is arguably the largest market in the world. In addition, we have the opportunity to bring this test to Canada on an exclusive basis. The fact that it does not require any upfront payment is also a great deal for our shareholders. We have been working tirelessly to set ourselves apart from the pack and I am confident the market will realize our value-add in the coming weeks.”
In consideration for the ongoing rights to distribute the Test Kits, the MOU contemplates that Blackhawk would put forward best efforts to certifications and licenses for the distribution of the Test Kits in North and South America. No cash will be paid, or securities issued, in consideration for the grant of the distribution rights. The grant of the distribution rights to the Corporation remains subject to completion of due diligence, the negotiation of definitive documentation, and completion of customary regulatory filings associated with transactions of this nature.
The Corporation is at arm’s length from both of MBC and TBG. The grant of the distribution rights to the Test Kits neither constitutes a fundamental change or change of business for the Corporation, nor will it result in a change of control of the Corporation within the meaning of applicable securities laws and the policies of the Canadian Securities Exchange. No securities of the Corporation will be issued in connection with the transaction.
Readers are cautioned that the Corporation has not yet had an opportunity to conduct independent due diligence regarding the operation of the Test Kits and verification of testing statistics and data provided by MBC and TBG. The Corporation intends to establish this additional information through a due diligence review permitted under the terms of the MOU. One due diligence has been completed, and definitive documentation finalized, and subject to receipt of required regulatory approvals and licenses, it is anticipated that the Corporation would place orders for the Test Kits with MBC and TBG. The Corporation has not received any assurances as to the timeline for the manufacturing and distribution of the Test Kits in North and South American, or as to the capacity of MBC and TBG to produce a sufficient volume of the Test Kits to make distribution economically feasible.
The Corporation will provide a further update regarding the grant of distribution rights once due diligence has been completed and definitive documentation finalized.
About TBG Biotechnology Corp.
TBG Biotechnology Corp. (TBG) is a global molecular diagnostics company dedicated to the development, manufacture and marketing of molecular diagnostics kits, instruments and services. With its research and development based in the US, Taiwan and China, TBG manufactures its products in its ISO13485 certified facility in Xiamen, China serving the clinical labs of both hospitals and independent reference labs, blood centers and bone marrow registry labs around the world.
For more information on TBG Biotech, please visit their website here: http://www.tbgbio.com/en
For further information please contact:
Frederick Pels, Chief Executive Officer
Cautionary Note Regarding Forward-Looking Statement
All statements in this press release, other than statements of historical fact, are “forward-looking information” with respect to the Corporation within the meaning of applicable securities laws, including with respect to completion of the acquisition of the distribution rights for the Test Kits, the approval of the Test Kits by the United States Food and Drug Administration, and Health Canada, and the marketing and distribution of the Test Kits in North and South America. The Corporation provides forward-looking statements for the purpose of conveying information about current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. By its nature, this information is subject to inherent risks and uncertainties that may be general or specific and which give rise to the possibility that expectations, forecasts, predictions, projections or conclusions will not prove to be accurate, that assumptions may not be correct and that objectives, strategic goals and priorities will not be achieved. These risks and uncertainties include but are not limited those identified and reported in the Corporation’s public filings under the Corporation’s SEDAR profile at www.sedar.com. Although the Corporation has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking information, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. The Corporation disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise unless required by law.