Diagnostics Archives - Bay Area Lyme Foundation

In Memory of Brandon Jutras, PhD

By Bay Area Lyme Foundation

It is with profound sadness that all of us at Bay Area Lyme Foundation mourn the loss of Brandon Jutras, PhD, an extraordinary scientist, a treasured research partner, and a dear friend to so many in the Lyme disease community.

Brandon was one of the brightest minds in Lyme disease research. Brilliant, endlessly curious, and driven by a genuine desire to improve the lives of Lyme patients, he dedicated his career to understanding Borrelia burgdorferi, the bacterium that causes Lyme disease. His work transformed our understanding of bacterial biology and pathogenesis while opening entirely new avenues for the development of desperately needed diagnostics and treatments.

Bay Area Lyme Ventures Invests in LymeLess Health to Accelerate AI-Powered Innovation for Lyme & Tick-Borne Disease Patients

By Bay Area Lyme Foundation

FOR IMMEDIATE RELEASE

Bay Area Lyme Ventures Invests in LymeLess Health to Accelerate AI-Powered Innovation for Lyme & Tick-Borne Disease Patients

Investment supports launch of AI care companion, Ella, designed to help Lyme+ patients navigate diagnosis, treatment, and long-term disease management

PORTOLA VALLEY, Calif., August 22, 2026 — Bay Area Lyme Ventures, Bay Area Lyme Foundation’s venture philanthropy initiative devoted to advancing solutions for Lyme disease, today announced that it has invested in LymeLess Health , an AI-powered digital health company focused on transforming how people with Lyme disease navigate diagnosis, treatment, and long-term care. The announcement coincides with the launch of LymeLess’ patient app powered by Ella, an intelligent AI health companion designed specifically for Lyme and tick-borne disease (Lyme+) patients.

The investment reflects Bay Area Lyme Ventures mission to accelerate promising innovations that have the potential to improve the lives of Lyme disease patients by advancing new diagnostics, therapeutics, digital health technologies, and data-driven approaches to care.

“People with Lyme disease often spend months or years searching for answers while trying to manage an extraordinarily complex illness,” said Linda Giampa, founder and managing director of Bay Area Lyme Ventures. “Bay Area Lyme Ventures was created to help accelerate innovations that can change that trajectory. LymeLess combines patient experience, artificial intelligence, and real-world data in a way that has the potential to empower patients while generating insights that could ultimately advance research across the Lyme disease field.”

“We Take Every Case Personally”: Understanding Lyme Disease Biobank’s Tissue Recovery Program

By Bay Area Lyme Foundation

Bay Area Lyme Leading the Way series

A behind-the-scenes look at how Wauchita Green and Pauline Lui help turn patients’ tissue donations into research that is changing the future of Lyme disease.

Lyme Disease Biobank, a program of Bay Area Lyme Foundation, partners with the National Disease Research Interchange (NDRI) to help advance Lyme disease research. Together, they enable patients to contribute tissue samples, collected during surgery or after death, which the Biobank shares with approved scientists studying infection and immune response. NDRI’s nationwide recovery network ensures these precious donations are handled with care and respect. This partnership helps turn patient generosity into real progress, accelerating the search for better diagnostics, treatments, and ultimately, a cure.

The Biobank also partners with MyLymeData, allowing Lyme patients registered with the Biobank to link their MyLymeData profile to their tissue donation, if desired.

When families whose lives have been impacted by Lyme disease call to talk about donating tissue, they’re often overwhelmed. But thankfully, the NDRI private donor team is standing by 24/7/365 to help. Patients and families typically want to know:

“How much does this cost?”
“What actually happens?”
“Is this going to be complicated?”

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.

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.

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.

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.