FDA Updates Test Policy to Support Point-of-Care Quantitative Immunity Testing

15 Nov 2021

As part of the FDA's goal to support increased access to at-home and point-of-care COVID-19 testing efforts, the US based agency has announced it will focus on approving requests for various diagnostic tests, including lab-based and point-of-care antibody tests that are capable of measuring the concentration of antibodies (fully quantitative antibody tests) against COVID-19, or the amount of neutralizing antibodies high-volumes.

"This move by the FDA reflects the global demand for technology that helps to ensure vaccination and booster programmes are effective." says Damian Camp, Orbis Diagnostics' President. “We’re seeing a growing demand from the public with people wanting to know what their immune response looks like.  People are starting to think about the timing of booster shots which is particularly important before we head into Winter. We don’t want to see a fourth wave of Covid like the Northern Hemisphere is currently experiencing.

“The FDA’s position further supports Orbis' development of its quantitative immunity test for COVID-19, which can measure neutralizing antibodies from a finger-prick of blood in 15 minutes. The technology is specifically designed for high-volume testing at point of need locations such as the doctor's office, pharmacy, or the border."

Orbis plans an Emergency Use Authorisation request to the FDA in the New Year and is confident this policy update will accelerate their review and approval process. Meanwhile in New Zealand, the Orbis Arca is now registered with MedSafe, New Zealand's medical device authority.

"This is not just about offering immunity testing to the general public to help inform timing of booster shots. We also believe it is especially important to keep our front-line and healthcare workers safe. Our trial data, which is consistent with international research, shows everyone’s response to vaccination is different, therefore people may require their booster shot at different times, depending on their COVID-19 antibody levels." says Mr Camp.

Click here to keep updated on availability of Orbis' test in New Zealand.