Lyme diagnostics Archives - Bay Area Lyme Foundation

Bay Area Lyme Ventures Invests in Galaxy Diagnostics to Advance Tick-Borne Disease Testing

Galaxy Diagnostics and Bay Area Lyme Ventures

By Bay Area Lyme Foundation

FOR IMMEDIATE RELEASE

Bay Area Lyme Ventures Invests in Galaxy Diagnostics to Advance Tick-Borne Disease Testing

Partnership Aims to Accelerate Innovation in Diagnostic Tools for Patients with Complex Tick and Vector-Borne Illnesses

DURHAM, NC., June 2, 2026 – Galaxy Diagnostics, a leader in advanced vector-borne disease testing, has announced a strategic investment from Bay Area Lyme Ventures, the newly launched impact investment fund created by Bay Area Lyme Foundation to accelerate innovation in Lyme and tick-borne disease diagnostics and therapeutics.

With reported tick-borne disease cases more than doubling in the United States over the past two decades, the investment underscores the growing urgency for more accurate and accessible diagnostic tools for complex vector-borne illnesses.

Founded by leaders in vector-borne disease research, Galaxy Diagnostics was created to address a critical gap in medicine: the detection of stealth pathogens that often go undiagnosed by conventional testing. The company has become known for advancing diagnostics designed to help providers better identify complex infections associated with Lyme and other vector-borne diseases.

Galaxy’s growing portfolio includes advanced molecular testing, antigen detection technologies, and diagnostic collaborations to translate emerging scientific discoveries from the lab into real-world clinical tools. Backed by hundreds of peer-reviewed publications and partnerships with leading academic researchers, the company continues to advance new standards for precision in tick-borne disease diagnostics.

“We are honored to receive support from Bay Area Lyme Ventures at a critical moment for tick-borne disease diagnostics,” said Nicole Bell, CEO of Galaxy Diagnostics. “Bay Area Lyme has funded much of the foundational research that Galaxy is now bringing to patients — the investment in Galaxy reflects their commitment to seeing those innovations through to the clinic, and to ensuring that better diagnostics actually reach the people who need them.”

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.”

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 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.

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.

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.

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.

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.