KU-developed at-home COVID-19 test inches towards store shelves

Published: Sep. 10, 2021 at 6:22 PM CDT
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LAWRENCE, Kan. (WIBW) - An at-home COVID-19 test developed by researchers at the University of Kansas is inching closer towards being stocked on store shelves.

With another surge of COVID-19 raging across the country due to the Delta variant, the University of Kansas says an at-home test for the virus developed by its researchers has moved closer toward commercial production. The goal is to launch the at-home test in early 2022.

“They’re building the handheld instrument right now,” said Steven Soper, a Foundation Distinguished Professor with appointments in the departments of Mechanical Engineering and Chemistry. “Following our successful proof-of-concept testing as a result of funding from the NIH, it will go into production and marketed by BioFluidica.”

According to KU, Soper’s team includes a half-dozen graduate students in bioengineering and chemistry. The team has worked on the project since early June 2020 and has repurposed “lab on a chip” technology previously developed to give doctors simple tools to more easily and quickly diagnose conditions that range from a stroke to a variety of cancers.

The University said the idea is that the chip will be used to select SARS-CoV-2 virus particles straight from saliva samples and count them one at a time. At-home users would spit on the test chip, then use a hand-held electronic reader, which is about the size of an iPhone, in order to analyze the results. It said the entire process would take about 15 minutes.

KU said Soper’s group, which includes his private company, BioFluidica, works with an undisclosed company that has experience in large-scale medical manufacturing in order to produce the chip consumables and handheld units. The tests would cost about $10, which can be reused many times over.

According to the University, the project would also require emergency use authorization from the U.S. Food and Drug Administration. Documentation for the handheld will be submitted to the FDA in the fourth quarter of 2021.

Soper said the emergency of the Delta variant means that COVID-19 testing will continue to be needed for the foreseeable future. He said his team is already working to adapt the test to detect Delta and other mutations to the virus.

“We’re making sure we’re ready to handle any variant that may be generated and that may pop up in the United States,” Soper said. “Not everyone’s getting vaccinated. There’s always going to be a population that won’t be vaccinated. What happens is, if they get infected, that means the virus can change — and they can reinfect people, even people who have been vaccinated.”

According to Soper, the new device could eventually be used to diagnose other illnesses quickly, including the flu and other viruses, as well s bacterial infections. However, he said COVID is the most pressing issue at the moment.

“This is always a moving target with COVID-19,” Soper said. “Everyone needs to be careful.”

The University said Soper earned his doctorate in bioanalytical chemistry from KU in 1989 and returned as a faculty member in 2016. He brought his company, BioFluidica, along with him, which previously created new products to help doctors test for various types of cancers, including breast, colon and prostate cancer. Funding to develop the new at-home tests comes from the National Institute of Health RADx Program.

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