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August 25, 2020 03:01 ET | Source: Victory Square Technologies Inc.
Victory Square Health received US FDA permission to commence marketing, sales and distribution under EUA
Safetest Covid-19™ test can confirm whether you’re currently infected with the virus causing Covid-19 or whether you were infected before and didn’t know it
VANCOUVER, British Columbia, Aug. 25, 2020 (GLOBE NEWSWIRE) -- Victory Square Health Inc. (“VS Health” or the "Company") – a portfolio company of Victory Square Technologies Inc. ("Victory Square") (CSE:VST) (OTC:VSQTF) (FWB:6F6) announced today that it was granted permission by the Food & Drug Administration (FDA) in the United States to commence marketing, sales and distribution under the emergency use authorization (EUA) for its Safetest Covid-19 assay for detecting the virus causing Covid-19. Safetest Covid-19 IgG /IgM has demonstrated to the U.S. FDA 93.5% sensitivity and 98.7% specificity.

With 22,977,399 confirmed cases and 800,321 deaths as of August 22nd, 2020, according to the European Centre for Disease Control, the economic damage from Sars-Cov-19 has been deep and widespread. In addition to obtaining greater insights into SARS-CoV19, and accelerating the development of vaccines, better, faster, and less expensive testing is one of the key requirements to successfully and safely opening the economy and getting 2,000,000 post secondary school students in Canada and 16.6 American undergraduates back to school.

"Our mission is to help the global community by delivering the best tests in the market," said Felipe Peixoto, CEO of Victory Square Health. "Testing is one of the most important actions in the push to get back to the normalcy. Safetest Covid-19 is our contribution to this challenge."

The antibody data provided by the Safetest Covid-19 IgM/IgG Elisa test kit covers both immunoglobulins type M (IgM) and G (IgG). When IgM antibodies are present, they can indicate that a patient has an active or recent infection with SARS-CoV-2. When IgG antibodies are present, it indicates a past infection and exposure.

The FDA has been working with manufacturers to accelerate new testing options that improve detection and diagnosis Covid-19 with the EAU program. The result is special exemptions and an accelerated permission process for reliable and validated technology that is accompanied by data. The EAU process by the FDA provides the green light for Victory Square Health to manufacture, market and provide Safetest Covid-19 Elisa kits to high complexity labs in the United States. Based on the strength of test results, Victory Square Health will be submitting an application to EU-CE. Victory Square Health is anticipating permission from ANVISA Brazil from a previously submitted application.

“Based on our outreach and discussions, the demand for this type of test from distributors around the world is high,” said Victory Square Health CEO Peixoto. “Victory Square Health will be providing assistance to as many nations as possible through these distribution channels.”

Elisa like Safetest Covid-19 antibody test results are crucial for developing a clear understanding of immunity thresholds and characteristics of infected individuals. High sensitivity antibody tests provide detailed profiles of populations and individuals. This information helps to accelerate the development of vaccines and provides crucial insight into natural immunity and potential thresholds, if they exist. This information will get people back to work, school and normalcy faster and safer.

“We’re looking forward to working with these important agencies and health practitioners using Safetest Covid-19,” said Shafin Diamond Tejani, CEO of Victory Square. “The test has demonstrated excellent reliability through valid data, and we’re energized by the opportunity to contribute to Canada’s domestic and international fight against the pandemic.”

The Safetest Covid-19 IgM / IgG Elisa test kits will be produced and available to labs all over the United States in the next few weeks.

Victory Square Health was founded in 2016 to accelerate the development of personalized medicine and technology solutions including diagnostic tests to support patient’s care and improve health outcomes.