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New Bay Area Lyme Foundation Study Shows Common FDA-Cleared Lyme Tests Miss 64-78% of Early Cases, Underscores Urgent Need for Improved Diagnostics

By Bay Area Lyme Foundation

FOR IMMEDIATE RELEASE

New Bay Area Lyme Foundation Study Shows Common FDA-Cleared Lyme Tests Miss 64-78% of Early Cases, Underscores Urgent Need for Improved Diagnostics

Research published in the Journal of Clinical Microbiology

PORTOLA VALLEY, Calif., April 21, 2026 –Bay Area Lyme Foundation, a national nonprofit and leading sponsor of tick-borne disease research in the US, today announced the publication of new research in the Journal of Clinical Microbiology based on data from its Lyme Disease Biobank. The study found that the commonly used FDA-cleared diagnostic testing methods available to providers and major national diagnostic laboratories are highly insensitive and miss 64-78% of early Lyme disease cases, including those who present with the characteristic erythema migrans (EM) Lyme rash.

“This study demonstrates that common two-tiered Lyme tests, utilized for decades, often fail to detect early Lyme disease and are leaving patients behind, highlighting a critical need for improved medical education on the limitations of current diagnostics,” said Liz Horn, PhD, MBI, Principal Investigator of Lyme Disease Biobank and lead author of the study. “Our findings also add to the evidence that improved diagnostics, ideally those that directly detect the bacteria that cause Lyme disease, are urgently needed.”

This large-scale, head-to-head study comparing 2 standard two-tiered testing (STTT) and 2 modified two-tiered testing (MTTT) diagnostic algorithms (the commonly used Lyme disease diagnostic algorithms) confirms that the sensitivity of two-tiered testing algorithms is low among patients with early infection. For the 107 early Lyme disease cases evaluated, the various testing algorithms missed 64-78% of early Lyme cases. Overall, only 39% (42/107) of participants with early Lyme disease were STTT or MTTT positive by any of the 4 algorithms.

New Peer-Reviewed Publication Highlights Evidence of Mother-to-Child-Transmission of Lyme Disease Bacteria During Pregnancy and Calls for Urgent Research

By Bay Area Lyme Foundation

FOR IMMEDIATE RELEASE

New Peer-Reviewed Publication Highlights Evidence of Mother-to-Child-Transmission of Lyme Disease Bacteria During Pregnancy and Calls for Urgent Research

New paper in Frontiers in Medicine reports results of meeting of international researchers at the Banbury Center of Cold Spring Harbor Laboratory

PORTOLA VALLEY, Calif., April 9, 2026 –Bay Area Lyme Foundation, a national nonprofit and leading sponsor of tick-borne disease research in the US, today announced publication of a new peer-reviewed article in Frontiers in Medicine examining the transmission of the Lyme bacteria during pregnancy. The publication points to observational research demonstrating that Lyme bacteria are capable of being transmitted from mother to unborn child and recognition by both the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) of the potential for mother-to-child transmission. With approximately 500,000 Americans diagnosed with Lyme disease each year and the related correlation of transmission during pregnancy being associated with serious adverse pregnancy outcomes, such as miscarriage, stillbirth, or congenital infection that occur in some cases, the paper concludes that the clinical impact of Lyme disease on pregnancy and infant health is an important public health issue that has been insufficiently studied.

“As an infectious disease pediatrician, I have seen firsthand the impact of Lyme disease in children and have suspected that the infection may have been passed from mother to child during pregnancy in a number of my patients, based on their medical histories,” said Charlotte Mao, MD, of Bay Area Lyme Foundation and a co-author of the study. “The first case studies of mother-to-child transmission were observed in the 1980s, yet decades later, we still lack sufficient research and clear, evidence-based guidance on Lyme in pregnancy and adverse pregnancy outcomes. This is an important public health issue and underscores the urgent need for rigorous studies to fully understand the risks and support patients and healthcare providers in making informed decisions that better protect maternal and infant health.”

Study authors highlight the great need for real-world studies clarifying how Lyme Borrelia, the bacteria that cause Lyme disease, the most common vector-borne disease in the US, behaves during pregnancy, and quantifying the outcomes for mothers and infants. Specifically, the paper suggests the creation of large, prospective studies of pregnant individuals with Lyme disease, including systematic long-term clinical follow-up of their children, as well as the importance of collecting biological samples from mothers, placentas, and infants through coordinated biorespositories for use in current or future studies.

Dr. Somer DelSignore: Congenital Lyme, PANS/PANDAS & Hope for Families

By Bay Area Lyme Foundation

Somer Delsignore, DNP

Dr. Somer Delsignore, DNP, is a Doctor of Nursing Practice and board-certified pediatric nurse practitioner specializing in complex chronic illness in children. Her clinical work focuses on the diagnosis and management of immune dysfunction using a root-cause approach. She developed the R.E.S.E.T. Protocol using a Root Cause lens to treat Immune Dysfunction systematically. A fellow of MAPS and AAOT and a member of ILADS, her expertise includes autoimmune, neuroimmune, and psychiatric manifestations of infectious diseases, especially tick-borne illnesses, as well as links to Autism Spectrum Disorder, PANS/PANDAS, and autoimmune encephalopathy. Delsignore completed her graduate and doctoral training at the University of Pennsylvania and SUNY Upstate Medical University, graduating magna and summa cum laude, and trained at leading pediatric centers, including Children’s Hospital of Philadelphia (CHOP), Penn State Children’s, and Children’s Health in Dallas. She is the CEO and Founder of Hudson Valley Integrative Health in Beacon, New York.

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Improving Lyme Diagnostics, Biomarkers, and Treatment: Inside Dr. Peter Gwynne’s Research

By Bay Area Lyme Foundation

Bay Area Lyme Leading the Way series

“I wanted to be doing work that was driven by clinical need… and there are a lot of clinical needs in Lyme disease.”

– Peter Gwynne, PhD

For too many people with Lyme disease, the journey begins with uncertainty. A missed rash. A negative test. Symptoms that don’t make sense. A diagnosis that comes too late, or not at all. Bay Area Lyme Foundation believes this must change. And we believe change happens through funding rigorous science, innovative thinking, and supporting researchers willing to tackle the hardest questions head-on.

One of those scientists is Tufts researcher Peter Gwynne, PhD, a microbiologist whose work sits at the cutting edge of Lyme research and is the recipient of our 2022 Emerging Leader Award. We spoke with Dr. Gwynne to get an inside look at his work and understand how this may impact Lyme patients in the future. His focus is simple to state but complex to achieve: develop better diagnostics, identify meaningful biomarkers, and move the field toward treatments and even prevention strategies that could fundamentally reshape how Lyme disease is understood and managed.

Drawn to Lyme by the Urgency of the Need

Dr. Gwynne did not begin his career in Lyme disease. He trained in molecular microbiology, studying pathogens such as Salmonella and Staphylococcus, the bacteria responsible for serious infections, including those often acquired in hospital settings. But over time, he found himself seeking work that could make a tangible difference for patients.

A Foot-Tapper and Smile-Creator! Lyme Patient Releases New Jazz Album

By Bay Area Lyme Foundation

Bay Area Lyme Spotlight Series

“Every listen helps fund Lyme research.”

– Steve Ehrlich

Steve Ehrlich emigrated to the San Francisco Bay Area from South Africa in 1989. Chronic Lyme Disease cut short his career in the software industry, and he turned to writing music. He has released two contemporary jazz albums with his virtual band, The Inter Section. He spends his days on his sofa writing music with his doggie, Frankie, hitting play and paws when needed. The second jazz album is now available on all the streaming apps, and, like his first album, all the proceeds will be donated to Bay Area Lyme.

We Need a New Generation of Lyme Doctors: James Bruzzese, MD, is Leading the Way

By Bay Area Lyme Foundation

Bay Area Lyme Spotlights Series

“Some institutions are evolving in research and education, but it’s not translating to clinical practice.”

– James Bruzzese, MD

When James Bruzzese, MD, talks about Lyme disease, he doesn’t speak in abstractions. He speaks as a brother who watched his sister lose her ability to walk; a son who watched his father leave his job to become a full-time caregiver; and as a medical student who sat in lecture halls knowing that what was being taught about Lyme and tick-borne disease was grossly incomplete.

Now, as a young physician preparing to open a practice dedicated to treating Lyme and tick-borne disease patients in New York, James represents something the Lyme community urgently needs: a new generation of doctors who understand that Lyme is real, that patients deserve better, and that the status quo must be challenged.

“It Was Traumatic. We Thought We Might Lose Her.”

Amy Offutt, MD: Lyme, Integrative Medicine, & True Healing

By Bay Area Lyme Foundation

Amy Offutt, MD

Dr. Offutt is the medical director and co-owner of Heart & Soul Integrative Health and Yoga which she co-founded with her husband, Brad, in 2007, located in Marble Falls, Texas. Her first seven years of practice were focused on rural family medicine and obstetrics after which she transitioned to approach the treatment of chronic inflammatory diseases using integrative medicine. She completed medical school at The University of Texas Health Sciences Center in San Antonio and completed a residency in Family Medicine at Christus Health. She has completed a fellowship with the American Academy of Anti-Aging and Regenerative Medicine and has a Master’s Degree in Integrative Medicine from George Washington University.

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Bacterial Mechanism That Could Help Prevent and Treat Lyme Arthritis Identified by New Bay Area Lyme Foundation–Supported Study

By Bay Area Lyme Foundation

FOR IMMEDIATE RELEASE

Bacterial Mechanism That Could Help Prevent and Treat Lyme Arthritis Identified by New Bay Area Lyme Foundation–Supported Study

Research published in PLOS Pathogens highlights a cell wall–driven trigger of joint inflammation, pointing to new ways to target Lyme arthritis

PORTOLA VALLEY, Calif., January 20, 2026 — Bay Area Lyme Foundation, a leading sponsor of Lyme disease research in the United States, announced the publication of new research in PLOS Pathogens identifying a novel mechanism that may trigger Lyme arthritis, one of the most common and debilitating complications of Lyme disease in the US. The study provides new insight into how the structure of Borrelia burgdorferi peptidoglycan, a component of the bacterium’s cell wall, and its interaction with a Borrelia protein can provoke joint inflammation. In a preclinical model, subtle changes researchers made to the bacterium’s peptidoglycan structure nearly eliminated arthritis despite ongoing infection, suggesting new approaches to reduce Lyme arthritis and joint damage that may complement antibiotics by targeting inflammatory bacterial components.

“Understanding how these bacterial structures provoke inflammation is an avenue towards new approaches for limiting long-term joint damage and possibly treating patients whose symptoms persist despite standard antibiotic therapy,” said Brandon L. Jutras, PhD, lead author of the study and associate professor of Microbiology-Immunology at Northwestern University Feinberg School of Medicine, and a Bay Area Lyme Foundation 2021 Emerging Leader Award winner. “Our findings offer critical insight into how Lyme arthritis is largely driven by specific structural components of Borrelia burgdorferi that may be targeted independent of the other aspects of the infection.”

This new study demonstrates that the chemical makeup and physical structure of peptidoglycan, a structural component of the Borrelia cell wall, play a decisive role in determining whether joint inflammation develops. It also demonstrates how impeding peptidoglycan’s interaction with a specific Borrelia protein may impact the bacterium’s ability to migrate to and persist within joint tissue, resulting in near elimination of Lyme arthritis in the study.

Dr. Casey Kelley: From Lyme & Mold to Optimum Health

By Bay Area Lyme Foundation

Bay Area Lyme Spotlight Series

Click here to watch or listen now

In a powerful Ticktective™ episode, host Dana Parish sits down with Casey Kelley, MD, Founder and Medical Director of Case Integrative Health, to unpack the complex world of Lyme disease, mold toxicity, environmental illness, and whole-body healing. Dr. Kelley had her own health journey with chronic fatigue, POTS, and other symptoms that led her to specialize in Lyme, tick-borne diseases, mold illness, long COVID, and other complex chronic illnesses. She brings clarity, compassion, and years of integrative and functional medicine experience to help patients understand what’s driving persistent symptoms and what true recovery can look like.

“The nervous system is utterly important to healing. And that entire system gets really thrown off with chronic infections exactly the same way that trauma with a capital T will cause dysfunction in the system.”

– Casey Kelley, MD

A New Year Call to Action After December 15, 2025, HHS Roundtable

By Bay Area Lyme Foundation

Bay Area Lyme Spotlight Series

By Charlotte Mao, MD, MPH, Bay Area Lyme Foundation

“Chronic Lyme Disease patients have been ignored for too long. That must end now.”

– Charlotte Mao, MD, MPH

A Long-Overdue Moment of Recognition

Starting in 2026, Lyme disease and other tick-borne disease patients and their families have some reason to be encouraged by the growing recognition of the realities they face and the prospect of continued research to support new diagnostics and treatments.

The December 15, 2025, Department of Health and Human Services (HHS) roundtable marked something rare and long overdue: federal recognition of patient need, grounded in scientific evidence presented by researchers, clinicians, and patient advocates. But patients need more than another moment of recognition. They need results. In 2026, the question is whether that recognition will translate into sustained action, measurable progress, and real improvements in care.