Teen researchers in suburban Atlanta may have cracked one of diagnostics’ toughest challenges: early Lyme detection. Their CRISPR test shows promise for identifying infection long before standard tools can.
For laboratory leaders navigating a rapidly shifting diagnostics landscape, a new signal of future innovation is emerging from an unexpected place: a suburban high school lab in Georgia. Lambert High School’s student researchers have engineered a CRISPR-based prototype that may detect Lyme disease days after infection—a potential breakthrough that, if validated, underscores how quickly synthetic biology is advancing and how early the next generation is entering the field.
Clinical laboratory professionals will be happy to note the promising work that the next generation of lab scientists has started.
The students, all part of Lambert High School’s elite synthetic biology team near Atlanta, set out to solve what senior Claire Lee called one of medicine’s most stubborn blind spots. “We’re doing something in our high school lab that could potentially have a huge impact for, like, millions of people,” she said. “This thing could help save lives.”
Using CRISPR, the powerful gene-editing tool, the teens developed a prototype test that appears capable of detecting Lyme disease just two days after infection, far earlier than the two-week window required by current assays. Although based on simulated blood serum and still in proof-of-concept stages, their findings were compelling enough to earn praise from scientists and secure a top-10 finish at the International Genetically Engineered Machine (iGEM) competition in Paris.
High School Genetic Engineers With an Ambitious Plan
Led by team captains Sean Lee and Avani Karthik, the CRISPR-based system targets a protein produced in the earliest moments of Lyme infection. “One of the biggest problems with Lyme is the lack of, like, being able to diagnose it,” Karthik said. They even met one patient who went “15 years without a diagnosis.”
Their idea was to use CRISPR to cut away extraneous DNA, revealing the protein so it could be detected with a rapid, kit-style test which is much like the COVID-19 diagnostic format. The students also explored using a different CRISPR system to block Lyme-causing bacteria as a potential therapeutic alternative to antibiotics.
But the team’s vision initially met resistance. Biotechnology teacher Kate Sharer said she warned students, “This project in particular, I told them: this is very high risk, high reward.” She admitted, “I couldn’t imagine any of this working,” though she supported their efforts. External experts were similarly cautious. As co-captain Sean Lee recalled,
“They did tell us in the beginning that this might not be so feasible because you’re trying to tackle such a big thing.”
A Top-Notch Lab Inside a Public School
Lambert’s program stands out nationally. Its county-funded, corporate-supported lab rivals those at universities, and the school draws families who relocate specifically for opportunities like iGEM. The team—entirely Asian-American this year and mostly children of immigrants—accepts roughly 10 members from about 100 applicants. Students pitch project ideas, test into the program, and endure what the team calls “insanely long hours.”
In September, after months of work, the students saw the data they had hoped for. Their system flagged early Lyme markers in as little as two days. It wasn’t human-blood–validated, but it was enough to push the project forward.
They spent the last weeks before the competition building a website, compiling results and pulling all-nighters to finalize their presentation.
Showdown in Paris
Arriving in Paris in late October, Lambert joined more than 400 teams from around the globe. Projects ranged from designing Mars-ready crops to developing enzymes to fight indoor mold. Janet Standeven, who oversees iGEM’s high school division and founded Lambert’s program, said she believes synthetic biology education is essential.
Janet Standeven noted that when federal funding for statewide programs was cut, she felt “absolutely devastated” and “angry,” though a judge has since temporarily restored the support. (Photo credit: Engineering Biology Research Consortium)
Stanford professor and iGEM co-founder Drew Endy warned that the U.S. risks losing ground in biotechnology as China accelerates national investment. “It’s urgent that leadership of the next generation of biotechnology has a strong presence in America,” he said. After seeing Lambert’s work, he added, “They appear to have developed a better diagnostic for Lyme disease than anything I’ve seen before.”
China’s Great Bay team ultimately won the grand prize. Lambert, nominated in five categories, earned the award for best software tool and finished among the top 10 high school teams worldwide—the only American team to do so.
For the Lambert students, the recognition mattered, but the mission mattered more. As Claire Lee put it, working on a test with the potential to save lives made every long night “worth it.”
A new Hybrid Lyme ELISA test shows promise for faster, more accurate early detection of Lyme disease, potentially streamlining lab workflows and improving patient care.
A newly developed serologic test for Lyme disease could significantly improve early detection and streamline the diagnostic process, according to a study published in the Journal of Clinical Microbiology. Researchers say the test, called the Hybrid Lyme ELISA, offers higher sensitivity in the earliest stages of the disease than currently approved methods, potentially reshaping clinical practice.
For laboratory leaders, the emergence of the Hybrid Lyme ELISA marks a potentially pivotal shift in diagnostic testing. With Lyme disease cases approaching half a million annually in the US, labs remain at the forefront of detection and reporting, yet current two-step testing protocols are labor-intensive, time-consuming, and lack sensitivity in early-stage patients. A single-tier, high-sensitivity serologic test could streamline workflows, reduce turnaround times, and enable labs to deliver more actionable results—especially for patients who present with erythema migrans, where current methods fall short.
In a press release on the study, study co-author Gary P. Wormser, MD, New York Medical College said, “This test could potentially change the standard of clinical practice, allowing clinicians to diagnose all manifestations of Lyme disease with a time-saving one-step antibody test.”
Lyme Disease and Current Testing Challenges
Lyme disease, caused by the bacterium Borrelia burgdorferi in the US and related species in Europe, is the most common vector-borne illness in the country, with nearly half a million cases diagnosed each year, according to the Centers for Disease Control and Prevention (CDC). The earliest and most common symptom is a skin rash called erythema migrans, which appears at the site of a tick bite.
If untreated, the infection can spread and cause neurological, cardiac, and joint problems. Early antibiotic treatment is highly effective, but timely diagnosis has remained a challenge.
Since 1995, the CDC has recommended a two-step serology process: an initial antibody screening test, usually an ELISA, followed by a confirmatory test. Originally, the Western Blot was required for confirmation, but in 2019, the CDC allowed a second ELISA instead. While reliable, this sequential approach can delay results.
Neither method is sensitive enough to recommend testing for patients in the erythema migrans stage, leaving early cases often undiagnosed.
A One-Step Approach
Developed by Kephera Diagnostics in collaboration with New York Medical College and the Lyme Disease Biobank, the Hybrid Lyme ELISA employs a novel immunoassay principle. It takes advantage of a unique biological response in which antibodies generated by Borrelia infection can simultaneously bind to two related, though not identical, antigens.
This dual-binding design allows the test to achieve both high sensitivity and specificity in a single step—performance that rivals or exceeds current two-tiered testing.
In the study, the Hybrid ELISA showed sensitivity of more than 90% in patients with erythema migrans, an improvement over the low sensitivity of existing FDA-approved methods. That could make it the first serologic test capable of reliably diagnosing patients in the earliest stage of Lyme disease.
“Current two-tiered serology tests are insensitive in early Lyme disease, missing up to 70% of patients presenting with erythema migrans,” said study co-author Liz Horn, PhD, MBI, principal investigator of the Lyme Disease Biobank, a Bay Area Lyme Foundation program.
Liz Horn, PhD, MBI, principal investigator of the Lyme Disease Biobank noted, “More accurate tests are urgently needed, and the Hybrid ELISA results are very promising.”
Potential to Change Clinical Practice
As an ELISA, the new test can be run manually or on automated high-throughput systems, making it suitable for widespread use in clinical laboratories. Researchers believe it could reduce time, cost, and complexity in diagnosing Lyme disease, while providing earlier answers for patients.
“The publication of this study is an important milestone in our efforts to bring about meaningful improvements in the diagnosis of Lyme disease that will benefit both patients and clinicians,” said Andrew Levin, PhD, chief executive and scientific officer at Kephera Diagnostics. “We are very excited by the results that were achieved by the Hybrid Lyme ELISA in this initial study. Naturally, these findings will have to be corroborated in larger-scale trials, which are currently underway.”
Kephera Diagnostics is now pursuing regulatory approval for the test and plans to make it available through its CLIA-certified laboratory while larger trials continue.
Funding and Collaboration
The Hybrid Lyme ELISA was developed with support from the National Institute of Allergy and Infectious Diseases through a Small Business Innovation Research (SBIR) grant. Collaborators included scientists at New York Medical College and the Lyme Disease Biobank, which provided critical patient samples.
If validated in larger trials and approved, experts say the test could become the first widely available one-step serologic test for Lyme disease, capable of diagnosing patients from the earliest rash stage through later, systemic disease.
