Health Canada has granted approval for the Hyris bCUBE to be used as a medical device for COVID-19 human testing. As a portable device, the Hyris bCUBE provides onsite and accurate results in minutes. This timely approval arrives as Canadians face rising COVID-19 cases and it supports the testing capabilities of provincial programs to meet demand.
The Hyris bCUBE is a portable DNA-testing laboratory in a box, offering Point of Care (POC) testing wherever people are—anytime, anywhere. Controlled by any device with an internet connection, including a smartphone, the scientifically validated bCUBE analyzes test samples through a cloud-based platform that delivers accurate results in minutes.
The bCUBE was previously approved and used for surface testing. Now, with Health Canada's approval for human testing, more Canadians and businesses can access testing that is accurate, quicker and less invasive—wherever they are in the country. This is particularly significant for vulnerable or remote communities, businesses or industries, where access to onsite rapid testing is key.
Considered the "gold standard" according to the CDC and WHO's effective testing guidelines, the bCUBE deploys PCR (Polymerase Chain Reaction) technology that has demonstrated a 95%+ accuracy rate in clinical trials. Similar trials are currently underway with the FDA.
"The bCUBE is a small, portable genomic biotechnology that is ideal for onsite, immediate test results," confirms Dr. Steven Newmaster, University of Guelph Genomics Professor. "We have validated the bCUBE after using it for several years in the food and natural products industry to identify pathogens, microbes, animal and botanical species ingredients."
Songbird Life Science is the exclusive Canadian distributor of the Hyris bCUBE. Along with several DNA/RNA-identification technologies that Songbird can deploy to suit a space or community's specific requirements, the bCUBE is a key component to Songbird's risk-management consultancy services.
"Health Canada's approval of the Hyris bCUBE addresses big gaps in testing capability and accessibility for Canadians," says Deleo de Leonardis, co-founder of Songbird Life Science. "This is key to keeping the economy running and people safe, despite the ongoing pandemic. Test results in minutes is a game changer."
Hyris is a UK-based company producing bCUBEs in Italy and Germany in accordance with the strictest quality and engineering requirements. Interested businesses can purchase bCUBEs through the Songbird Life Science website. Songbird is currently working with government officials at all levels to assess how this technology can be best deployed to remote communities and other locations where the need for onsite COVID-19 testing with rapid results is especially urgent.