BOZEMAN, Mont., July 30, 2020 (GLOBE NEWSWIRE) — Alercell today announced that it has reached an agreement for distribution of COVID-19 rapid antibody serology tests with manufacturer Medigen Biotechnology Corp, (TPEX 3176 MEDIGEN) a publicly traded company-controlling shareholder of TBG Biotechnology Corp.
ALERCELL is a biotechnology company based in Montana, USA with offices in New York City. Alercell has run internal validation studies of a number of rapid antibody tests notified to the US Food and Drug Administration under Emergency Use Authority (EUA) and has retained just three for distribution. Alercell research supports that these tests are efficient, valid and have superior accuracy. “We are confident that the TBG Rapid Antibody Test is among the most accurate serology tests and we are pleased to work with Medigen,” said Dr Alexandre Scheer, Chief Medical Officer of Alercell.
FDA has listed as notified almost 200 tests under EUA authority and is in the process of reviewing and terminating some notifications based on failure to validate through independent NCI review. It is therefore extremely important for medical companies to buy from a source that internally validates the tests presented, as some of the products made available on the market may be questionable and may become obsolete quickly if the FDA is not satisfied by the NCI review.
Medigen/TBG has received full EUA authorization from FDA for its PCR test and TBG is expecting EUA authorization for its rapid serology test, which can now be marketed in notified status pending full EUA review, within days/weeks.
In addition, Alercell has researched the production capacity of various manufacturers and found that some manufacturers have limited industrial capacity, whereas Alercell has the capacity to deliver tests in very large quantity.
With this $280,000,000 distribution agreement, Alercell is positioning itself at the forefront of the fight against Covid-19 in North America.
Alercell is a Biotechnology company based in Bozeman, Montana. Created in 2020 by a group of veterans of medical research, Alercell’s principle business is in the discovery, development, manufacture, and sale of an efficient treatment to the Covid-19 pandemic and Alercell is currently actively seeking a Covid 19 advanced treatment plan using stem cells. Alercell intends to expand its operations to a broad and diversified line of health care solutions to infectious diseases. For more information, please visit: www.alercell.com