bay area lyme Archives - Bay Area Lyme Foundation

Journal of Clinical Microbiology Studies Demonstrate Two Investigational Diagnostics Outperform Current Tests in Detecting Early Lyme Disease

By Bay Area Lyme Foundation

FOR IMMEDIATE RELEASE

Journal of Clinical Microbiology Studies Demonstrate Two Investigational Diagnostics Outperform Current Tests in Detecting Early Lyme Disease

Studies utilize Bay Area Lyme Foundation’s Lyme Disease Biobank samples to point to the promise of single-tier diagnostics to potentially transform early detection

PORTOLA VALLEY, Calif., October 9, 2025 — Bay Area Lyme Foundation, the leading nonprofit funder of Lyme disease research in the US, today announced results from two independent studies published in Journal of Clinical Microbiology, conducted by researchers at Tufts University School of Medicine, and Kephera Diagnostics, respectively, demonstrating the potential of novel investigational single-tier Lyme disease tests to improve accuracy in the earliest stages of infection. Each study uses well-characterized samples from Bay Area Lyme Foundation’s Lyme Disease Biobank and demonstrated unprecedented accuracy, far exceeding the current CDC-recommended Lyme disease two-tier test, which can miss up to 70% of early-stage cases as well as later-stage cases.

“The CDC’s standard two-tier Lyme diagnostic misses the majority of early cases, delaying treatment and increasing the risk of developing persistent, debilitating symptoms for patients. The two novel single-tier assays—while not yet FDA-cleared for clinical use—point to a future where Lyme disease can be diagnosed quickly, accurately, and with a single test,” Liz Horn, PhD, MBI, a coauthor on both studies, and Principal Investigator of Lyme Disease Biobank, a Bay Area Lyme Foundation program that provides much-needed samples to approved researchers working to better understand tick-borne diseases and develop improved diagnostic tests and therapeutics. “These single tier tests, like InBios Lyme Detect™ and Kephera’s Hybrid Lyme ELISA could mark a turning point for Lyme diagnostics, giving physicians and patients more accurate tools that are urgently needed.”

The first study, evaluating the InBios Lyme Detect™ Multiplex ELISA, was conducted by Pete Gwynne, PhD, a 2022 Bay Area Lyme Emerging Leader Award (ELA) winner, and colleagues at Tufts University School of Medicine. Using samples from the Lyme Disease Biobank, this new diagnostic correctly identified all two-tier positive samples evaluated in the study, while also detecting 21 of 79 clinically diagnosed patients who were missed by following the current CDC guidance for testing using FDA-cleared standard two-tier tests (STTT) and had erythema migrans (EM) skin lesions. Importantly, the InBios test maintained >99% specificity, with only one false positive across more than 200 control and lookalike disease samples and was shown to be highly reproducible.

“Improving diagnostics for early Lyme detection is critical to reducing missed cases and enabling patient access to treatment when it is most effective, helping prevent disease progression,” said Pete Gwynne, PhD, Research Assistant Professor of Molecular Biology and Microbiology at Tufts University School of Medicine. “The use of Lyme Disease Biobank samples to validate this research highlights the important role biorepositories can play in innovative science.”

InBios’ microarray-based assay is designed to capture reactivity against a set of 10 different Borrelia burgdorferi antigens simultaneously including VlsE and multiple OspC variants, and it uses machine learning to analyze results, identifying complex patterns.

“The Lyme Detect Multiplex ELISA offers a significant improvement in early Lyme detection while simultaneously providing important independent IgG and IgM antibody reactivity against a broad panel of targets,” said James Needham, PhD, Director of New Product Development at InBios International.

Another recent independent study published in the Journal of Clinical Microbiology in August found Kephera Diagnostics’ Hybrid Lyme ELISA demonstrated 94% sensitivity in patients with EM skin lesions, compared to just 64% for STTT and 76% for modified two-tier testing (MTTT). The Hybrid Lyme ELISA likewise outperformed both two-tier methods in detection of EM patients within the first week after onset of symptoms. This single-tier test achieved equivalent specificity to both STTT and MTTT, based on a unique approach that requires antibodies to bind both the Borrelia C6 peptide and the VlsE protein. The test is now in clinical trials to support an FDA submission.

“Our Hybrid Lyme ELISA demonstrates that it’s possible to achieve both high sensitivity and high specificity in a single-tier format, even in the earliest stages of Lyme disease,” said Andrew Levin, PhD, Chief Executive and Scientific Officer of Kephera Diagnostics, who led this study using samples from the Lyme Disease Biobank, the CDC, and New York Medical College. “Access to well-characterized samples was essential to validating this approach and moving the field closer to a reliable, first-line diagnostic for Lyme.”

About Lyme disease
The most common vector-borne infectious disease in the US, Lyme disease is a potentially disabling infection caused by bacteria transmitted through the bite of an infected tick to people and pets, and can be potentially passed from a pregnant mother to her unborn baby. If caught early, most cases of Lyme disease can be effectively treated, but it is commonly misdiagnosed due to lack of awareness and inaccurate diagnostic tests. There are more than 620,000 new cases of Lyme disease each year, according to Bay Area Lyme Foundation estimates. As a result of the difficulty in diagnosing and treating Lyme disease, up to two million Americans may be suffering from the impact of its debilitating long-term symptoms and complications, according to Bay Area Lyme Foundation estimates.

About Lyme Disease Biobank
Lyme Disease Biobank (LDB), a program of Bay Area Lyme Foundation, is a non-profit organization working to accelerate research of Lyme disease and other tick-borne infections. With a collection of biological specimens from more than 1,250 participants, including blood, serum, plasma, urine and tissue, LDB provides much-needed samples to approved researchers working to better understand tick-borne diseases and develop improved diagnostic tests and therapeutics. Blood and urine samples are collected from the Northeast, Upper Midwest and West Coast areas of the US, and tissue samples are collected throughout the country. Researchers interested in obtaining samples should visit www.lymebiobank.org or contact info@lymebiobank.org.

About Bay Area Lyme Foundation
Bay Area Lyme Foundation, a national organization committed to making Lyme disease easy to diagnose and simple to cure, is the leading public charity sponsor of innovative Lyme disease research in the US. A 501c3 organization based in Silicon Valley, Bay Area Lyme Foundation collaborates with world-class scientists and institutions to accelerate medical breakthroughs for Lyme disease. It is also dedicated to providing reliable, fact-based information so that prevention and the importance of early treatment are common knowledge. Historically, a pivotal donation from the LaureL STEM fund covered all overhead costs through 2024. In 2023, a Bay Area Lyme Endowment was formed, which allows for 100% of all donor contributions to the Bay Area Lyme Foundation to go directly to research and prevention programs in perpetuity. For more information about Lyme disease or to get involved, visit www.bayarealyme.org or call us at 650-530-2439.

About InBios
Since 1996, InBios has been a leader in the development of diagnostic tests for emerging infectious diseases and biothreats. Products are designed for superior performance, efficiency and value. These include several FDA market authorized and CE marked assays for arboviruses, parasitic infections, biothreats, and more. InBios continues to anticipate and serve the growing global public health demand. Products in the pipeline include next generation platforms for Chagas, dengue, tick-borne and respiratory diseases. For more information, visit www.inbios.com.

About Kephera Diagnostics
Kephera Diagnostics is a young and growing company that is addressing the public health challenges of global infectious diseases using new assay technologies. We also operate a CLIA-certified and CAP-accredited diagnostic laboratory delivering excellence in specialized diagnostics. We focus on diagnostic solutions for diseases where there are significant gaps in addressing patient needs, particularly in underserved areas of healthcare including infectious diseases and women’s health. Our mission is to promote more effective and affordable medical treatment through faster diagnosis. We collaborate with a global community of researchers and clinicians to develop and translate new technologies into accessible products for clinical diagnostics and research applications.

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Media Contact:
Tara DiMilia
Phone: 908-369-7168
Tara.DiMilia@tmstrat.com

Dr. Jyotsna Shah: Inside IGeneX’s Game-Changing Lyme Test

By Bay Area Lyme Foundation

Jyotsna Shah, PhD

Dr. Jyotsna Shah is an immunologist and molecular biologist with over 40 years of experience in diagnostic tools for tick-borne diseases. She holds a Ph.D. in diagnostic immunology from the University of Nairobi and conducted postdoctoral work at Harvard University. Shah joined IGeneX in 1997, becoming Laboratory Director in 2003 and now serving as President and CEO.

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Mikki Tal, PhD: Chronic Infections, Fertility, & Immunity: MIT Immunoengineer Makes Groundbreaking Lyme Discoveries

By Bay Area Lyme Foundation

Mikki Tal, PhD

Mikki Tal, PhD, is a Principal Scientist at MIT’s Department of Biological Engineering and Associate Scientific Director of the MIT Center for Gynepathology Research. She leads the Tal Research Group, focusing on host-pathogen interactions, immune responses to infections like Lyme disease, and the mechanisms behind chronic illnesses, particularly their disproportionate impact on women. She earned her PhD in Immunobiology from Yale University and conducted postdoctoral research at Stanford University’s Institute for Stem Cell Biology and Regenerative Medicine. Tal was the recipient of our 2018 Bay Area Lyme Foundation Emerging Leader Award.

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Dr. Joe Burrascano: A Masterclass on Tick-Borne Illness

By Bay Area Lyme Foundation

Ticktective Podcast Transcript

In this episode of Ticktective™, host Dana Parish interviews Joe Burrascano, MD. Dr. Burrascano is a pioneer in the field of Lyme disease, having treated patients since the early days of the illness in the 1980s and 1990s. He co-founded the International Lyme and Associated Diseases Society (ILADS) to help train clinicians in treating Lyme and associated tick-borne diseases. Dr. Burrascano discusses the challenges in diagnosing and treating Lyme, including issues with the limited testing criteria and the chronic, multisystemic nature of the disease. He outlines his approach to treating early Lyme with a “hybrid” antibiotic regimen, as well as the use of pulsed and cycling antibiotic therapies for chronic cases. He also highlights the importance of addressing underlying health factors like immune dysfunction, toxin buildup, and co-infections like Bartonella and mold toxicity in chronic Lyme patients. Dr. Burrascano emphasizes the need for a holistic, patient-centered approach to managing complex, persistent tick-borne illnesses.

“If you have something that’s every part of your body is bothering you, and it comes and goes and it moves around, of course, you’re going to be labeled as a little bit cuckoo. It’s not. It’s Lyme disease.”

– Joe Burrascano, MD

Dana Parish: Welcome to the Ticktective Podcast, a program of the Bay Area Lyme Foundation, where our mission is to make Lyme disease easy to diagnose and simple to cure. I’m your host, Dana Parish, and I’m the co-author of the book Chronic, and I sit on the advisory board of Bay Area Lyme Foundation. This program offers insightful interviews with scientists, clinicians, patients, and other interesting people. We’re a nonprofit based in Silicon Valley, and thanks to a generous grant that covers a hundred percent of our overhead, all of your donations go directly to our research and prevention programs. For more information about Lyme disease, please visit us@bayarealyme.org.

Justin Timberlake’s Lyme Diagnosis and His Struggle to Be Believed

By Bay Area Lyme Foundation

Bay Area Lyme Spotlights Series

Medical skepticism isn’t just cruel, it’s physically, mentally, and emotionally harmful.

When Justin Timberlake revealed his Lyme disease after weeks of criticism for low-energy performances during his recent tour, the Internet did what the Internet does: It immediately questioned whether he was telling the truth.

The skepticism was rife and merciless. Reddit threads quickly surfaced with accusations that he was making excuses, faking illness, or using Lyme as a convenient cover story. “There must be something else going on,” people assumed. “Chronic Lyme isn’t a thing,” they said.

While it’s almost expected to see anonymous Internet commenters take aim at a major celebrity going through a low point, for the millions of Americans living with Lyme disease, Timberlake’s experience is not surprising at all.

Teaching Kids to Protect Themselves from Tick Bites

By Bay Area Lyme Foundation

Bay Area Lyme Spotlights Series

“Lyme and ticks are talked about a lot more! Students are showing peers their tick keys and sharing information, and even staff are discussing it around campus.”

– Melissa Kelly, teacher

Children are the most at-risk group for contracting tick-borne diseases, so Monterey Peninsula health educator, Melissa Kelly, gave her students an important assignment during Lyme Disease Awareness month: design a poster to teach their school community about Lyme and tick-borne diseases and how to prevent tick bites. Bay Area Lyme Foundation provided tick keys and educational materials to support Melissa’s teaching and curriculum. We asked Melissa to tell us about the project!

Q: Melissa, tell us about your school, where it’s located, and how you learned about Lyme disease awareness month.

A: Chartwell School is located in Seaside, California. We serve students with learning differences such as dyslexia and more. Our school community includes students from 1st to 12th grade. I work specifically with high school students. I first learned about Lyme Disease Awareness Month after my own experience with Lyme disease. Before teaching, I worked as a field biologist and likely contracted Lyme during my fieldwork. Thankfully, I was able to get it treated, and I am okay. That experience has kept me engaged with the latest research and studies on tick-borne diseases, which is how I learned about Lyme Awareness Month.

Dr. Joe Burrascano: A Masterclass on Tick-Borne Illness

By Bay Area Lyme Foundation

Dr. Joe Burrascano

Dr. Joseph J. Burrascano Jr., a pioneer in the field of Lyme, began his practice in East Hampton, NY, in 1981, where he identified and detailed the clinical aspects of Lyme in a high-prevalence area. Renowned for his groundbreaking diagnostic and treatment guidelines since 1984, he has advised the CDC, NIH, and U.S. Senate, authored extensive publications, and is a founding member of ILADS, continuing to educate globally.

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New Bay Area Lyme Foundation Study Reports That Only One-Third of Early Lyme Patients with On-Going Symptoms Followed up with their Healthcare Providers

By Bay Area Lyme Foundation

FOR IMMEDIATE RELEASE

New Bay Area Lyme Foundation Study Reports That Only One-Third of Early Lyme Patients with On-Going Symptoms Followed up with their Healthcare Providers

The new research, published in Frontiers in Medicine, points to need for greater follow-up from medical professionals to address potential treatment failures.

PORTOLA VALLEY, Calif., July 10, 2025—Bay Area Lyme Foundation, a leading sponsor of Lyme disease research in the US, announced the publication of new research in Frontiers in Medicine based on data from Bay Area Lyme Foundation’s Lyme Disease Biobank. This large-scale study conducted over 10 years at sites on the East Coast and the Upper Midwest demonstrates the need for improved diagnostics and increased follow-up by medical professionals for Lyme disease patients.

Only one-fifth of study participants (23%), enrolled with signs and symptoms of early Lyme, were positive by the CDC’s standard two-tiered test for Lyme disease, which supports previous research that found that it misses up to 70% of cases of early-stage Lyme disease. Further, approximately 1 in 5 patients reported ongoing symptoms at 3 months, including joint pain, fatigue, and muscle pain yet only one-third (35%) of these participants followed up with their healthcare providers about these ongoing symptoms. Due to difficulties in diagnosing Lyme disease and resulting treatment delays, as many as two million people may suffer from persistent Lyme disease, which can be debilitating.

Accurate, timely detection of Lyme disease is critical to preventing long-term complications. Moreover, follow-up from medical professionals with all patients after they complete antibiotic treatment could improve outcomes and reduce the burden of Lyme disease,” said lead author Liz Horn, PhD, MBI, Principal Investigator of Lyme Disease Biobank, a Bay Area Lyme Foundation program which helps to accelerate research by collecting, storing and providing much-needed human biological samples for use in research. “Our data also confirm the limitations of serology testing in early Lyme disease and after antibiotic treatment.”

Tick-borne Disease Prevention for City Employees

By Bay Area Lyme Foundation

Bay Area Lyme Spotlights Series

“Tick-borne diseases are a growing public health concern in California and across the country. Educating the community and supporting prevention efforts is essential.”

– Guillermo Calvillo, Staff Specialist

For the past four years, Bay Area Lyme Foundation has partnered with the City of San Jose’s Environmental Services Division (ESD) to offer free tick-bite prevention and Lyme disease awareness training to employees whose jobs in the field place them at risk of exposure to ticks. As part of our ongoing education efforts, we spoke with Staff Specialist Guillermo Calvillo to learn more about his department’s work—and why tick-bite prevention matters to his team.

BAL: What do you do?

Calvillo: I work at the City of San Jose Environmental Services Division (ESD). I am in charge of all aspects of safety training and compliance for the entire ESD. I have been with the city for almost five years, and I have learned a great deal while enjoying being part of the ESD team.

The Lyme-Mold Connection: An Incredible Guide to Healing

By Bay Area Lyme Foundation

Bay Area Lyme Quick Bites Series

“I think I prevented a lot of chronic Lyme cases by doing adequate early treatment. But I had a subset of patients who just were not getting better. These cases had either a current or a past exposure to mold.”

– Jill Crista, ND

In this latest episode of Ticktective^™, our host, Dana Parish, talks with Dr. Jill Crista, a leading expert on the diagnosis and treatment of toxic mold exposure and illness. Dr. Crista started her practice in southern Wisconsin, which is often in the top five states for Lyme disease cases, even though Lyme is often thought of as a Northeast issue.

Click here to watch or listen now.

Parish and Crista discuss the complex nature of mold toxicity, including its impact on the immune system, the brain, and various organ systems. Crista emphasizes the importance of identifying the underlying causes of mold exposure, such as water damage and poor indoor air quality, rather than just addressing the symptoms.