Lyme disease biobank Archives - Bay Area Lyme Foundation

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.

A Leader Who Understands the Journey: Welcoming David Walsey as Bay Area Lyme Foundation’s New Executive Director

By Bay Area Lyme Foundation

Bay Area Lyme Spotlight Series

“Science drives our mission, but patient stories remind us why the science matters.”

– David Walsey

As David Walsey steps into his new role as Executive Director of Bay Area Lyme Foundation, he brings more than professional expertise. He brings lived experience of diagnostic uncertainty, immune dysfunction, co-infections, and the long arc many families travel before answers emerge. For patients, caregivers, and supporters of Bay Area Lyme, David’s leadership signals both continuity and momentum: a future rooted in rigorous science, compassionate leadership, and hope grounded in progress. “It’s been a long journey to get here,” David says. “We’ve spent nearly a decade navigating tick-borne disease as a family. That experience changed everything for us.” Dana Parish interviewed David as part of our Ticktective^™ video podcast series. Watch or listen to the complete interview.

When Symptoms Don’t Fit the Textbook

Nearly ten years ago, David’s son began experiencing a constellation of symptoms that defied easy explanation. Despite multiple medical evaluations, no unifying diagnosis emerged. When Lyme disease was finally identified, the family initially felt relief. “I thought this was a solvable, short-term problem,” David recalls. “You treat it, and life goes back to normal.”

Bay Area Lyme Foundation Highlights Research Leadership and Momentum in Tick-Borne Disease, Names New Executive Director

By Bay Area Lyme Foundation

FOR IMMEDIATE RELEASE

Bay Area Lyme Foundation Highlights Research Leadership and Momentum in Tick-Borne Disease, Names New Executive Director

Milestones include FDA-cleared diagnostics enabled by Lyme Disease Biobank, the launch of Bay Area Lyme Ventures, and 10 years since Lyme Disease Biobank provided its first samples, advancing the field

PORTOLA VALLEY, Calif., February 11, 2026 –Bay Area Lyme Foundation, a national nonprofit and leading sponsor of tick-borne disease research, today reflected on concrete progress in 2025 that demonstrates the maturation of more than a decade of investment in diagnostics, therapeutics, and research infrastructure for Lyme and other tick-borne diseases. As Bay Area Lyme Foundation-supported programs advance towards being available for clinicians and patients, the organization announced David A. Walsey, JD, LLM, as Executive Director. He has extensive experience offering strategic guidance to life sciences companies and a personal connection to Lyme disease that will help guide the foundation’s next phase of scientific translation and organizational growth.

In 2025, Bay Area Lyme Foundation reached an important inflection point as new diagnostic tests enabled by the foundation’s Lyme Disease Biobank secured FDA clearance. These new tests highlight the potential to move from discovery-stage research toward tools that can meaningfully improve patient care. The organization also launched Bay Area Lyme Ventures, an investment arm designed to help promising diagnostics and therapeutics move more efficiently from the laboratory into real-world use, while also creating the opportunity for returns to support future Bay Area Lyme Foundation research. This progress underscores the importance of the more than $30 million in research Bay Area Lyme Foundation has invested at leading academic and medical institutions such as Stanford, Johns Hopkins, Tulane, and Duke. Research supported by the foundation has produced over 70 peer-reviewed scientific publications and sustained collaboration across top research centers nationwide.

Bay Area Lyme Foundation Statement on the HHS Lyme Disease Roundtable

By Bay Area Lyme Foundation

The December 15, 2025, HHS roundtable on Lyme disease and other tick-borne diseases placed long-overdue national attention on the millions of patients and families who have lived with an “invisible illness” for far too long. One of the clearest messages of the event was that the era of dismissing or gaslighting Lyme patients must end. This reflects what our community has endured for years.

Secretary Kennedy Convenes Lyme Disease Patients and Providers to Announce New Diagnostic Efforts

The Bay Area Lyme Foundation welcomes this federal focus on the urgent need for accurate diagnostics, rigorous patient-centered research, and better access to care, including the acknowledgment that Lyme disease qualifies as a chronic condition within Medicare care frameworks. These priorities closely align with, and have long guided, the work we have led for more than a decade.

We initiated the Lyme Disease Biobank, which is now a cornerstone resource for diagnostic and translational research across the country and has attracted significant support from the Steven and Alexandra Cohen Foundation. Through additional philanthropic investment and scientific collaboration, Bay Area Lyme has also supported or co-funded many of the research advances referenced throughout the roundtable.

Better Tests, Better Answers

By Bay Area Lyme Foundation

Bay Area Lyme Leading the Way Series

“The IGeneX test is far more sensitive than most commercially available tests for Lyme disease, detecting far more positive patients compared to standard two-tier ELISA or Western Blot tests,”

– Jyotsna Shah, PhD

Click here to watch or listen now

For people living with or who suspect Lyme disease, getting a clear diagnosis can feel like the hardest part. Symptoms often mimic those of other illnesses, and traditional tests miss many cases.

In this episode of Ticktective™, Dr. Jyotsna Shah, President and Laboratory Director of IGeneX, shares with our host, Dana Parish, how her team is changing that—and how Bay Area Lyme Foundation helped make it possible.

Dr. Shah explains how partnerships between innovative labs like IGenex, Bay Area Lyme Foundation, and our Lyme Disease Biobank are helping deliver faster, more accurate diagnostics—and new hope for patients who’ve struggled for years to find answers.

Ten Years of Data, One Clear Message: We Need to Do Better for Lyme Patients

By Bay Area Lyme Foundation

Bay Area Lyme Leading the Way Series

By Liz Horn, PhD, MBI, Principal Investigator, Lyme Disease Biobank

“The window for effective antibiotic treatment is narrow. Miss it—because of a false negative test, because symptoms are dismissed, or because follow-up doesn’t happen—and patients can develop persistent Lyme, which can be debilitating.”

– Dr. Liz Horn

After a decade of collecting blood samples, testing the samples, tracking patient outcomes, and analyzing data from more than 800 participants, the numbers tell a powerful story about the gaps in our understanding of how we diagnose and treat early Lyme disease. And it’s made all the more urgent by this summer’s explosion in blacklegged (deer) tick populations across endemic areas.

Our latest Lyme Disease Biobank study looked at more than 250 patients with early Lyme disease on Long Island and in Central Wisconsin who provided a blood draw at enrollment and a second blood draw three months later. Published recently in Frontiers in Medicine, these 10 years of data confirm a few important points that have been known in the Lyme field for years, but the wider medical community may not be aware of.

Progress from Partnership: Reflections from the Frontlines

By Bay Area Lyme Foundation

Bay Area Lyme Leading the Way Series

Guest blog by Lyme Advocate, Meghan Bradshaw, Government Relations Manager, Center for Lyme Action

“Bay Area Lyme Foundation’s leadership, fundraising, and commitment to research and patient advocacy have been a bedrock.”

– Meghan Bradshaw

When I look back over the past few years, I’m struck by how much has changed—for me personally, and for the broader Lyme and tick-borne disease community. And perhaps most of all, I see how partnership and persistence have turned what once felt impossible into genuine progress.

Turning Pain into Purpose as a Living Donor

One of the most powerful examples of Bay Area Lyme’s impact is Lyme Disease Biobank—a groundbreaking resource that provides researchers with high-quality, well-characterized samples to accelerate discoveries in diagnostics and treatment.

I know firsthand what it means to contribute to that effort—with my own body. As a living donor, I’ve donated multiple joints to the Biobank following joint replacement surgeries. It was, without exaggeration, a painful process. But I did it because I believe in turning my suffering into solutions—knowing that those tissues may one day help someone else get diagnosed sooner or treated more effectively.

Accelerating Breakthroughs, Advancing Hope: How Bay Area Lyme Powers Lyme Disease Research

By Bay Area Lyme Foundation

Bay Area Lyme Leading the Way Series

“Every one of our success stories amplifies the ripple effect of philanthropy done right: targeted, strategic, and driven by measurable impact.”

– Katariina Tuovinen

For more than a decade, Bay Area Lyme Foundation has been rewriting the story of Lyme and tick-borne disease research. With a mission to make Lyme disease easy to diagnose and simple to cure, the Foundation has built a national reputation as a nimble, entrepreneurial engine for scientific innovation. Since its founding in 2012, Bay Area Lyme has invested more than $31 million to support over 60 groundbreaking studies and partnerships across 56 institutions nationwide, each one helping to transform the landscape of Lyme disease diagnostics, treatments, and prevention.

At the heart of this success lies a small but mighty force: The Bay Area Lyme Science Committee, led by Research Grant Director Katariina Tuovinen, MS, MBA, MA, together with pediatric infectious disease physician Charlotte Mao, MD, MPH, and Liz Horn, PhD, MBI, Principal Investigator of Lyme Disease Biobank. Together, this team guides a grantmaking strategy that prizes bold ideas, cross-disciplinary collaboration, and measurable impact—an approach that has introduced new talent, fresh perspectives, and innovative technologies to a field that desperately needs them.

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.

Bay Area Lyme Foundation Launches Bay Area Lyme Ventures as First Impact Investment Fund to Support Entrepreneurs and Companies Advancing Lyme Disease Solutions

By Bay Area Lyme Foundation

FOR IMMEDIATE RELEASE

Bay Area Lyme Foundation Launches Bay Area Lyme Ventures as First Impact Investment Fund to Support Entrepreneurs and Companies Advancing Lyme Disease Solutions

New venture philanthropy fund announces initial investments and will help guide game-changing Lyme diagnostics and therapeutics to commercialization

PORTOLA VALLEY, Calif., September 4, 2025 — Bay Area Lyme Foundation, a leading sponsor of Lyme disease research in the US, today announced the launch of Bay Area Lyme Ventures (Lyme Ventures), a bold new impact fund that is the first designed to attract and drive investment to promising tick-borne diagnostics and therapeutics nearing commercialization. By bringing together strategic research investments, collaborative partnerships, and patient-focused resources, Lyme Ventures aims to advance innovative diagnostics and therapeutics to fill significant gaps that exist in medical care. Today, the fund announces investments in Aces Diagnostics and LymeAlert, both of which are designed to help people bitten by ticks navigate the complicated process of getting an accurate diagnosis.

“This new chapter expands Bay Area Lyme Foundation’s commitment to accelerating innovative diagnostics and therapeutic breakthroughs, as there is an extreme scarcity of support for entrepreneurs and companies developing accurate solutions for patients and clinicians in tick-borne disease,” said Linda Giampa, who led Bay Area Lyme Foundation for the past 12 years and is now the founder and managing director of Bay Area Lyme Ventures.

Lyme Ventures will complement Bay Area Lyme Foundation’s continued commitment to funding scientific research by advancing promising discoveries into clinical development and, ultimately, through commercialization. To date, Bay Area Lyme Foundation has granted more than $30 million toward research, while Lyme Ventures has a goal of investing $5 million by 2027 into companies working to bring solutions to market. Proceeds from these philanthropic investments will fund research projects at Bay Area Lyme Foundation.