A new test for Lyme disease that helps lead to a more accurate result early in the infection? One company is working on it.
As the number of emergency room visits for tick bite related incidents reaches a five-year high, according to the Centers for Disease Control and Prevention, one company is working on a new test for Lyme disease that it said can help lead to a more accurate result early in the infection.
Dr. Paul Auwaerter, a professor of medicine at the Johns Hopkins University School of Medicine and the clinical director for the infection disease division, said the characteristic rash is usually a reliable indicator of Lyme disease.
But, he said, some people who get infected may not develop the rash, instead reporting a fever and feeling unwell, and the standard test isn’t positive.
There’s a newer, modified two-tier testing process, but Auwaerter said “there’s still much room for improvement.” There’s a window of two to four weeks, when commonly used tests aren’t very accurate because they’re not sensitive enough to pick up the infection, he said.
However, people who have been infected for more than four weeks “typically do have positive blood tests to the most frequently used antibody-based test for Lyme disease right now,” Auwaerter said.
“But it’s in this early phase that I think these investigators are purporting that their new approach may yield improved earlier diagnoses.”
ACES Diagnostics is working on the new test, which uses a type of artificial intelligence called machine-based learning. Holly Ahern, the company’s chief scientific officer, said ‘LymeSeek’ the test uses an algorithm to look at each individual person instead of using a standard interpretation.
The current tests rely “on those same 10 antigens that they’ve been looking at for the past 40 years,” Ahern said. “Ours uses different antibodies. We’re looking for a whole different set of antibodies.”
Ahern and ACES CEO Tammy Crawford said they were motivated to find a new approach after both of their daughters got sick with a mystery illness as teenagers. It became debilitating, and they learned long after the symptoms started that their kids had Lyme disease.
The test was developed with assistance from Tulane and Arizona State universities.
“Having a test that’s accurate early is so important, so that doctors have a tool that can give an actionable result,” Ahern said. “They’ll get a result that says, ‘This patient has Lyme disease.’ And so the next would be, what we do now is prescribe the antibiotic, and hopefully that will prevent long term complications down the line.”
The company just submitted its clinical plan to the U.S. Food and Drug Administration, and is meeting with the agency at the end of September. Clinical trials are scheduled to start in January, Crawford said.
Auwaerter said the bacterial infection is hard to culture, except in labs, so using DNA for PCR “just hasn’t panned out here as being better than antibody tests.”
Anyone who has fevers or an unexplained illness could consider bringing up the possibility of a tick-borne disease to their doctor, Auwaerter said.
“At least for Lyme disease, early detection of that remains a challenge, so it’s something that may need to be revisited or retested currently, until better tests are available,” Auwaerter said.
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