Vancouver’s Victory Square Health acquired Brazilian Covid19 test developers Safetest in June.
Today Safetest 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.
“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.
“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.
Victory Square Health is a portfolio company of publicly-traded Victory Square Technologies (CSE:VST).