Gerri Botte is nearing full approval for the rapid COVID-19 test developed in her lab.
In the summer of 2020, Texas Tech University‘s Office of Research Commercialization filed a patent application and applied for the COVID-19 Prioritized Examination Pilot
Program with the U.S. Patent and Trade Office.
The patent application was for Gerardine “Gerri” Botte, a professor and Whitacre Department Chair of the Department of Chemical Engineering housed within the Edward E. Whitacre Jr. College of Engineering.
Botte led a team of researchers – including doctoral student Ashwin Ramanujam and
Sharilyn Almodovar, an assistant professor in the School of Medicine at Texas Tech University Health Sciences Center (TTUHSC) – to create a COVID-19 test as accurate as the gold standard for current
testing and faster than present rapid tests.
The Ultra-Fast COVID-19 detection sensor is now in the final stages of approval from
the U.S. Food and Drug Administration (FDA.)
“In terms of having an emergency use authorization from the FDA, one of the requirements
that we have right now is to have the final system ready for the manufacturer and
having a manufacturing partner,” Botte said.
“We have the manufacturing partner engaged, the capacity to build, and we have our
final device. We’re doing the final clinical trials to finalize the application. We
had a pre-application submitted and we are in the stages of finalizing those two to
get the OK.”
When the pandemic began during the spring of 2020, Botte was working on different
sensors, particularly in the area of water treatment, and saw the opportunity to use
what she had already learned to help combat the pandemic.
“We were working in sensors, for instance, for E.coli detection, which you cannot
have in water because it will make people extremely sick,” she said. “You don’t want
that in food either. So, when the pandemic came all the labs got shut down. And then
I told my doctoral student Ashwin Ramanujam, who was working on the E. coli sensor,
‘I think there is a potential here to take our findings from the E. coli sensor, which
we already have a good baseline for, and see how we can use them for COVID-19.’”
The sensor Botte and her team created can detect the coronavirus in saliva within
seconds, but she also received a grant from the U.S. Department of Defense’s Defense
Advanced Research Projects Agency (DARPA) to develop an indoor detector, similar to a carbon monoxide detector, that could identify deadly
pathogens, like COVID-19, in the air.
Botte’s method involves passing an electrical signal through a chemical solution.
The SARS-COV-2 proteins that pass through this electrical field respond to the signal,
allowing the tester to determine if the virus is present.
A more traditional way to test for a virus – the gold standard Botte was required
to meet – is the Polymerase Chain Reaction (PCR) test. A PCR test is a three-step
process that allows for the identification of pathogenic organisms that are difficult
to culture by detecting their DNA or RNA.
“The other interesting thing about this is our detection limit is much lower than
the PCR by orders of magnitude,” Botte said. “What’s happening is that we could detect
it at a level the PCR has not done.
“In our clinical trials here at Texas Tech, we’ve been able to observe the virus in
some people who are asymptomatic – they don’t even know they have it – and then we
track it as a function of time and the amount of the virus. But, if that person took
a PCR test, it would not even show up as positive. So, our test enables us to track
if you’re just starting out with the virus or you’re almost finished with it.”