Diagnostics Archives - Page 2 of 8 - 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.

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.

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.”

Bay Area Lyme Foundation Announces National Winner of the 2025 Emerging Leader Award to Develop a Much-Needed Rapid, Low-Cost, Easy-to-Use Lyme Disease Test

By Bay Area Lyme Foundation

FOR IMMEDIATE RELEASE

Bay Area Lyme Foundation Announces National Winner of the 2025 Emerging Leader Award to Develop a Much-Needed Rapid, Low-Cost, Easy-to-Use Lyme Disease Test

Winner Chao Wang of Arizona State University will receive $150,000 to evaluate a unique diagnostic that uses gold nanoparticles and has been proven in other infectious diseases

PORTOLA VALLEY, Calif., June 12, 2025—Bay Area Lyme Foundation, a leading sponsor of Lyme disease research in the US, has given its 2025 Emerging Leader Award (ELA) to Chao Wang, PhD, associate professor in the School of Electrical, Computer and Energy Engineering at Arizona State University, faculty with ASU’s Biodesign Institute® and an expert in nanotechnology and biosensors. Wang will receive $150,000 to support his work to develop a much-needed rapid, low-cost, easy-to-use test, called Nano2RED-LD, for Lyme disease. The test aims to deliver results in as few as 30 minutes when a patient who may have Lyme disease first sees a doctor.

There is an immense need for better Lyme disease tests. Today’s standard-of-care tests miss too many cases at all stages of Lyme disease, including as many as 70% of early Lyme cases.

“With Lyme disease cases rising steadily across the U.S., the need for accurate and timely diagnostic tools has never been greater,” said Katariina Tuovinen, research grant director, Bay Area Lyme Foundation. “Dr. Wang’s pioneering work epitomizes the essence of this award as it applies innovation from other infectious diseases in an effort to enhance outcomes for patients affected by Lyme disease.”

The Numbers Don’t Lie: Why the NIH Consistently Underfunds Research into Lyme Disease

By Bay Area Lyme Foundation

An In-depth Interview with Kris Newby, Author of “Bitten”

“We need to let the NIH know that we’re watching them, and we want results.”

– Kris Newby

Kris Newby, author of ‘Bitten,’ is investigating government spending on Lyme disease research, which is strongly influenced by the flawed original disease definition of Lyme disease. She summarizes the impact of the 2018 Tick-Borne Disease Working Group’s report, explains where research funding has and is currently being directed, and calls for money to be spent on better diagnostics and treatments for Lyme disease sufferers instead. Kris explores potential actions that Lyme patients can take to help direct the course of funding, such as communicating with Congress, supporting advocacy groups, and donating to research organizations.

The views and opinions expressed in this article are those of the interviewee and do not necessarily reflect the views or positions of Bay Area Lyme Foundation.

Kris Newby is watching our government, and watching quite closely. She has a lot to say about how government money is spent on a disease that, according to CDC estimates, infects almost 500,000 people annually in the US, causing untold pain, suffering, loss of livelihood, and, in extreme cases, severe mental illness, including suicidal and homicidal events.

Of course, we are talking about Lyme disease—the pariah of infection-associated chronic conditions.

Toxic Load: Healing from Tick-borne Disease and Autoimmune Illness

By Bay Area Lyme Foundation

BAL “Quick Bites” Series

“If you have an autoimmune disease, our allopathic system does not have great answers that are solution-based or root cause-based to chronic complex illness.”

– Jill Carnahan, MD

In this edition of our Ticktective video and podcast series, Dana Parish sits down with Jill Carnahan, MD, a functional medicine doctor specializing in Lyme disease, tick-borne illnesses, mold toxicity, and other complex chronic health issues. Carnahan discusses her background growing up on a farm and how it influenced her approach to medicine. She shares her experience being diagnosed with breast cancer and the potential environmental factors, such as atrazine, that may have contributed to it. Carnahan talks about her cancer treatment and her belief in finding and addressing root causes in medicine. She then discusses her expertise in Lyme and tick-borne diseases, explaining how she evaluates and treats these conditions. She emphasizes the need for a clinical diagnosis of Lyme disease due to the limitations of mainstream tests. Carnahan also sheds light on the connection between mold exposure and chronic illness, including dementia and psychiatric disorders. She provides insights into testing, detoxification, and treatment strategies for mold-related illnesses. The interview concludes with information about connecting with Dr. Carnahan’s clinic, her book, and her documentary.

Understanding Infection-associated Chronic Illness: How the Immune System Responds to Persistent Infection

Distinguished Speaker Series with Michal Tal, PhD

By Bay Area Lyme Foundation

Distinguished Speaker Series Transcript

“I want to leave you with hope. I think we’re going to be unstoppable because I think that these are solvable problems. These are answerable questions. I think that there are already a lot of existing tools in immunology that just need to be brought into the fight, and we can change this.”

– Michal Caspi Tal, PhD

Michal Caspi Tal: In the chronic illness world, I think that there is something about hope with a capital ‘H’ that is precious. I think it always has to be. I want to talk a little bit about what my lab is doing, where I think we could go in the future and the hope that I have for how we move forward, how we solve this, and how we change this for those who come after us. So, I’ll tell you a little bit about some of the recent things that have come out of the lab, what the lab is working on now, and where we want to go.

New Study Shows How Borrelia burgdorferi Evades the Immune System

Recently, we published a study in collaboration with Hanna Ollila’s lab where we compared people who’ve had Lyme and have had a diagnosis of Lyme versus people who’ve never had a diagnosis of Lyme. We found a genetic difference in a sweat protein that nobody—including me—had ever thought about before. We tested it against the bacteria in our lab, and we saw that it had a huge effect; we tested it in mice, and it had a huge effect. So that’s really exciting. We had another paper that came online yesterday that is one of these last papers from my postdoctoral work over at Stanford, where we actually managed to figure out some of how Borrelia burgdorferi, the bacteria that causes Lyme, manages to evade immune clearance.

Any respectable pathogen that can establish a persistent infection needs to figure out your immune system to the point that it can evade it. The fact that it has persisted means that it was able to evade your immune clearance. And so, I got to that from a very interesting direction working on immune regulation, trying to understand these brakes on the immune response and how they impact the response to infection. The immune system has the power to kill you and obviously, nobody has any incentive for that to happen. So, there are a lot of mechanisms in place to put brakes on the immune system and reign it in. One of the huge developments in cancer over the last two decades has been reevaluating the question: can we take those brakes off? So in my postdoc, I was studying a particular checkpoint where this was turning into an exciting immuno-oncology target, and I said, ‘I want to look at how this checkpoint is used in infection.’ I realized that this checkpoint was being used to help you survive an acute infection, but created a vulnerability for pathogens to evade immune clearance and establish chronic infection much like it allows cancer cells to evade immune clearance. In an amazing collaboration with Irv Weissman, Balyn Zaro, and Jenifer Coburn we realized that the bacteria that cause Lyme disease manipulate this brake and that’s how I became fascinated with Lyme. But I also became concerned about turning off this brake in cancer patients because I was concerned about what would happen if you used this on cancer patients during an active infection. Indeed, the clinical trials on this drug were ended due to increased death from infection, and I wish it hadn’t been tested during a worldwide pandemic.

Matt Kaeberlein, Rapamycin, and the Dog Aging Project: What Animals Can Teach Us About Aging Better

By Bay Area Lyme Foundation

BAL “Quick Bites” Series

In scientific exploration, few fields captivate the imagination quite like the study of aging. It’s a universal process affecting all living beings, yet its mechanisms remain elusive and its implications profound. Recently, a spotlight has been cast on aging research through initiatives like the Dog Aging Project, spearheaded by Dr. Matt Kaeberlein. This ambitious endeavor aims not only to understand the biological underpinnings of aging in dogs but also to glean insights that could potentially enhance human longevity. At the forefront of this research is rapamycin, a drug with promising anti-aging properties. In our latest Ticktective interview, Dana Parish delves into the intricacies of this groundbreaking project with Dr. Kaeberlein and learns what animals, particularly dogs, can teach us about aging better.

“Investing in research on aging and companion animal health can pave the way for longer, healthier lives for both humans and animals.”

– Matt Kaeberlein

Young Hearts, Hidden Battles: A pediatric infectious disease physician’s perspective on Lyme disease and neuropsychiatric manifestations

By Bay Area Lyme Foundation

Distinguished Speaker Series Transcript

“Everything about this disease is infinitely more complex and nuanced than is taught to physicians.”

– Charlotte Mao, MD MPH

Charlotte Mao: Thank you Dana for that amazing introduction and Brandi too. I want to thank Brandi for so generously opening up your beautiful home for this event and Bay Area Lyme Foundation for inviting me to speak tonight about my personal perspectives as a pediatric infectious disease physician about Lyme disease in children, particularly neuropsychiatric manifestations.

When Brandi asked if I might give a talk for this Speaker Series, I suggested this topic because, first, I hope there might be something instructive in some of my personal musings on key lessons I’ve learned about Lyme disease in the course of caring for children with this contested disease. Second, I want to highlight neuropsychiatric manifestations because I feel they generally are the least recognized by physicians as being potential manifestations of Lyme disease. Yet, taking into account all levels of severity, they are, in my view, actually quite common—certainly not uncommon—and when severe, they are among the most devastating of Lyme manifestations to the lives of children and their families.

The Myth of the Bullseye: Why Recognizing the Spectrum of Lyme Disease Rashes is Critical for Diagnosis and Treatment

By Bay Area Lyme Foundation

BAL Spotlights Series

Anna Schotthoefer, PhD, a project scientist at Marshfield Clinic Research Institute in Wisconsin, discusses the collection and analysis of a specific subset of blood and urine samples for Lyme Disease Biobank—a Bay Area Lyme Foundation program—from patients diagnosed with tick-borne diseases in the state. Marshfield Clinic serves a large population in Wisconsin and Michigan’s Upper Peninsula, which are highly endemic for Lyme disease. Her Bay Area Lyme-funded study of the Marshfield samples focused on visual documentation of rashes associated with Lyme disease and the challenges in accurately diagnosing the disease based on these rashes. The results highlight the difficulties in recognizing early Lyme: only two of 69 patients presented with the classic bullseye rash that doctors learn is the gold standard for diagnosing Lyme from textbooks. Schotthoefer discusses the variety of different rashes that can result from a tick bite, the characterization of the spectrum of rashes, the need for better Lyme diagnostics, and the ongoing efforts to develop new testing methods using the samples collected in LDB. She expresses optimism that in the next five to ten years, there will be significant advancements in Lyme disease detection, diagnosis, and therapeutics—largely thanks to patients who have contributed samples to LDB for ongoing research.

“The textbooks doctors read in medical school tell them, ‘Look for a bullseye rash; look for the target-like lesion,’ and it turns out that’s wrong. There is a need to continue educating clinicians and providers that Lyme rashes are a spectrum.”

– Anna Schotthoefer, PhD