New Lyme Disease Test in Development

A company is developing a new test for Lyme disease that promises more accurate results early in the infection.

According to the Centers for Disease Control and Prevention, there’s been a significant rise in emergency room visits related to tick bites, reaching a five-year peak. In light of this, a company is focused on creating a test that could improve early detection of Lyme disease.

Dr. Paul Auwaerter, who teaches at Johns Hopkins University School of Medicine, notes that the characteristic rash is often a reliable sign of the disease. However, not everyone displays this rash. Some may experience fever and general malaise, while standard tests can fail to show positive results.

Despite the introduction of a newer, modified two-tier testing method, Auwaerter believes there’s still considerable room for improvement. He explains that there’s a two to four-week period when commonly used tests may not be sensitive enough to detect the infection.

On the brighter side, those infected for more than four weeks usually have positive results with the standard antibody test. “It’s really in the earlier phase where, I think, these researchers believe their new method could lead to quicker diagnoses,” he said.

The company ACES Diagnostics is spearheading this new test, leveraging a form of artificial intelligence called machine-based learning. Holly Ahern, the chief scientific officer, explained that ‘LymeSeek’ employs an algorithm to analyze data for each individual rather than using a generic interpretation.

Current tests typically examine the same 10 antigens that have been standard for decades. Ahern emphasizes that their method involves looking for entirely different antibodies. It’s noteworthy that both Ahern and ACES CEO Tammy Crawford were driven to find an alternative after each of their daughters fell ill with a mystery ailment during their teenage years, leading to a later diagnosis of Lyme disease.

This new test was developed in collaboration with Tulane and Arizona State universities. Ahern remarked on the importance of having an accurate early test, enabling doctors to provide actionable results. Once positive, doctors could then prescribe antibiotics to potentially prevent long-term complications.

Currently, the company has submitted its clinical plan to the U.S. Food and Drug Administration and plans to meet with the agency later this month. Clinical trials are anticipated to begin in January, according to Crawford.

Auwaerter pointed out that culturing the bacteria is challenging outside laboratory settings and that using DNA for PCR testing has not proved superior to antibody tests. He advised anyone experiencing unexplained fevers or illnesses to consider discussing the possibility of a tick-borne disease with their healthcare provider.

“Early detection of Lyme disease is still tricky, so it might be necessary to revisit or retest until more reliable tests come along,” he stated.