The difficulty of diagnosing early acute Lyme disease makes things doubly frustrating for the Pennsylvanians who live in a state that consistently ranks highest in the nation for Lyme disease cases.
However, Seattle-based Adaptive Technologies is working with clinical researchers across the country – including the Pittsburgh area – to conduct studies for a test that could better identify Lyme disease using technology similar to their Covid-19 test.
“We are able to use next-generation gene sequencing to read the genetics of the immune system and, in particular, the T cells that play an important role,” said Dr. Lance Baldo, Adaptive’s chief medical officer. “We use a similar technology and approach to diagnose Covid. We were able to identify what is known as a “signal” from T cells for Lyme disease. “
The absence or misdiagnosis of Lyme “can lead to pretty serious problems,” Baldo said. “We felt we had a really great opportunity to show that we can use T cells to diagnose disease reliably and accurately.”
Adaptive’s first T-cell-based test, T-Detect Covid, received emergency clearance from the FDA to confirm Covid infections during the pandemic.
As part of the ImmuneSense-Lyme study, Adaptive is working with researchers such as Dr. Shari Rozen in Pittsburgh to recruit people with recent tick bites who may have the classic bullseye rash.
“This is our first study,” said Rozen, family doctor and clinical researcher with Preferred Primary Care Physicians of Pittsburgh. “It differs from a typical study in that we are not concerned with treatment. We’re looking at a new test for Lyme. “
The study will be conducted blindly, meaning that neither Rozen nor the participants will know the results until all of the study data has been collected.
Rozen said her biggest challenge is finding patients who present with the bullseye rash.
“The best scenario would be the ability to identify patients with early-stage Lyme disease before they develop more serious and persistent symptoms,” she said. “The goal is to find them early, treat them early and avoid serious complications.”
The analysis of the study data leads to a final determination of the effectiveness of the test, and the health status of the participants is tracked for a full year.
“We’ll see how the people are,” said Baldo. “Has your T-cell signature fallen off or gone over time? What problems or complications have you encountered? We’ll learn a lot in the next few months. “
If the studies are successful, Baldo hopes to make it clinically and commercially available to diagnose patients.
In the meantime, both he and Rozen continue to recruit participants for the study. 52 participants have enrolled at two study centers in the Pittsburgh area.
Anyone presenting with a bullseye rash can sign up at ImmuneSenseStudy.com. Participants will receive $ 100 for each study visit, up to $ 400.
Patrick Varine is a contributor to Tribune Review. You can contact Patrick at 724-850-2862, pvarine@triblive.com, or on Twitter.
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