KU’s COVID-19 rapid test moves closer to being on the market

Published: Jan. 20, 2021 at 10:30 AM CST
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LAWRENCE, Kan. (WIBW) - A COVID-19 rapid test that is under development at the University of Kansas is moving closer to commercial readiness.

The University of Kansas says an at-home COVID-19 test developed by its researchers is now headed for commercial production.

“We’ve been talking to venture capitalists and large existing companies to help facilitate this translation that is taking the test out of the laboratory and moving it into the marketplace,” said Steven Soper, a Foundation Distinguished Professor with appointments in the School of Engineering and Department of Chemistry. “We’re doing this in a very accelerated fashion.”

KU said Soper’s team includes six graduate students in bioengineering and chemistry and has been focused on the project since early June of 2020. It said they have been repurposing “lab on a chip” technology Soper had previously developed to provide doctors with simple tools to more easily and quickly diagnosed conditions ranging from stroke to a variety of different cancers so that it could be used to choose SARS-CoV-2 virus particles directly from saliva samples and count them one at a time. Users at him would put saliva on the test chip, it said, then use a hand-held electronic reader that is about the size of an iPhone to analyze the results. It said the whole process would take around 15 minutes.

According to KU, getting the test to users requires more effort.

“We have to develop millions of chips that are used to analyze the saliva samples and look for these virus particles that give rise to COVID-19,” Soper said. “And then we have to manufacture the hundreds of thousands of the handheld units that are used to accommodate the chips and make the measurements and do this in a fully automated fashion appropriate for home use.”

“Moving it from the laboratory into a commercial platform is not an easy endeavor. I would argue it’s kind of easy to do this in the lab, but to take this into the home, to let anyone use it, takes a tremendous amount of planning,” he said.

KU said Soper’s team, which includes his private company, BioFluidica, is now planning with two commercial companies that have experience in large scale medical manufacturing to produce the chip consumables and the handheld units. It said users would be able to get a test for around $10 and the reader, which can be reused, for about $50. The project will also require emergency authorization from the FDA. It said the aim is to start the production and distribution by the beginning of the fourth quarter of 2021.

According to the University, by that time, vaccination of Americans for COVID-19 should be well underway, but Soper said experts have told him that the need for rapid testing will continue for up to two years. It said the test would also come in handy wherever groups of people gather like schools and sporting events.

“Is testing going to still be necessary? Absolutely,” Soper said.

Soper said a lesson he learned from the pandemic is that the nation needs to be better prepared to respond to future pandemics by building a stockpile of devices that can easily adapt to test for new viruses.

“We have to have high testing capacity for future pandemics,” he said. He noted that the world had already experienced various widespread epidemics in the 21st century, which include the H1N1 influenza outbreak in 2009.

According to KU, Soper earned his doctorate in bioanalytical chemistry from KU in 1989 and returned to the university as a faculty member in 2016. It said he brought with him his company, BioFluidica, which used to create new products to help doctors test for various types of cancers, including breast, colon and prostate cancer. It said the funding to develop the COVID-19 rapid test comes from the National Institute of Health RADx Program.

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