FRISCO, Texas — A small Frisco, Texas company has created what it believes could be the future of COVID testing and tests for other diseases.
“This is kind of a first of its kind chemistry lab in a box,” John Redmond, the president of InspectIR, said.
Thursday, the company’s COVID breathalyzer became the first FDA-authorized breathe test for COVID-19.
They had been working with the FDA for months to fine tune testing and legal language around the product before getting word of the authorizations Thursday.
“Was packing up getting ready to go home and, ‘hey, check your email’,” Redmond said. “The phone has been ringing off the hook, and it’s people who own testing centers. We’ve had other clinicians.”
The test comes in a Pelican case weighing about 40 pounds and roughly the size of carry-on bag. A straw plugs into an outside hole and the person being tested blows into it, getting a result in less than three minutes.
The FDA said the case, known as the PNY-1000, was more than 91% accurate detecting positive cases and more than 99% accurate at identifying negative samples. The FDA said a positive result should be confirmed with a molecular test.
“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health said in a statement Thursday. “The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the U.S. for the next public health emergency.”
Dallas County Public Health Director Dr. Phil Huang said while cases and testing demand are low, the test could be an important tool especially being less invasive than a swab.
“Our hospital numbers are still looking good,” Huang said. “We’re certainly interested in anything that can provide more rapid information, more supplemental information.”
Redmond said they can build 500 of the breath test machines per month. The top of the box includes a screen showing the test progress and result. Inside the opaque cases are a series of pumps, tubes and patented technology to test the gas.
The small company of five employees still has big ideas and sees possible uses at concerts or travel. They’re just authorized for Americans 18 years old and up, but use in schools is a future option, too.
“We all want to feel safe in wherever we are,” said Redmond.
In late 2017, the company already started creating a now-working breath test for cannabis and opioids. When COVID hit, they decided to pivot.
“Because it’s respiratory infection, we just asked the question, ‘can we help?',” Redmond said.
Now, the future is expanding it to other viruses and diseases.
“We’ll be able to quickly tell people what they’re currently suffering from and hopefully create that peace of mind,” Redmond said. “We really look forward to I guess helping more, going to look at other upper respiratory infections and going back to the drugs.”