LAWRENCE – Researchers at the University of Kansas are aiming to place on the commercial market in early 2022 an in-home, saliva-based testing unit for COVID-19.
Consumers would place saliva on a tiny test chip that would be analyzed by a reusable hand-held electronic device similar in size to a cellular telephone. Results would be available within 15 minutes. Disposable chips could cost about $10, while the reader might be priced around $50.
Documentation on reliability of this handheld system is expected to be presented later this year to the U.S. Food and Drug Administration. The FDA would need to provide emergency authorization to place it on the market. Funding for the research was provided by National Institutes of Health.
Steven Soper, a KU distinguished professor with joint appointments in mechanical engineering and chemistry, said the project had been under development through a private company, BioFluidica, in collaboration with a medical manufacturing company with experience with handheld units and chip technology. Identity of the production partner wasn’t disclosed by KU.
“They’re building the handheld instrument right now,” Soper said. “Following our successful proof-of-concept testing as a result of funding from the NIH, it will go into production and marketed by BioFluidica.”
Work on the reader began in June 2020 and involved a half-dozen KU graduate students in chemistry and bioengineering. The quick-turnaround COVID-19 testing unit would repurpose technology previously devised to assist physicians with diagnosis of health conditions.
Soper earned a doctorate in bioanalytical chemistry from KU in 1989 and returned to the university as a faculty member five years ago. He brought along his company, BioFluidica, which previously created products to test for breast, colon and prostate cancer.
He said technology adapted for detection of COVID-19 could be modified to track the delta variant as well as other changes 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.”
The FDA has granted emergency use authorization for more than 30 in-home or self-administered tests for COVID-19.
Demand for home tests escalated after emergence of the delta variant, which prompted supply and distribution challenges. Demand for testing had declined after the U.S. Centers for Disease Control and Prevention recommended vaccinated people without symptoms didn’t need testing despite possible exposure to the virus.
The CDC subsequently revised guidance to indicate vaccinated individuals ought to be tested three to five days after potential exposure to the virus and to wear a mask in public indoor spaces for 14 days or until securing a negative test result.