New Study Shows Less Than One-Third of Lyme Disease Test Results are Accurate for Patients with Lyme Rash

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New Study Shows Less Than One-Third of Lyme Disease Test Results are Accurate for Patients with Lyme Rash

Journal of Clinical Microbiology Publishes Lyme Disease Biobank Data Describing Samples Available for Research on Tick-Borne Infections

Portola Valley, Calif., February 26, 2020—Bay Area Lyme Foundation, a leading sponsor of Lyme disease research in the U.S., announces results published in the Journal of Clinical Microbiology, a journal of the American Society for Microbiology, that point to limitations of currently available diagnostic tests for early-stage Lyme disease and highlight the need for more research toward improved diagnostics and treatments. Among the findings, the Centers for Disease Control’s Standard Two-tier Testing Algorithm (STTTA) for Lyme disease failed to accurately diagnose 71% of blood samples from individuals presenting with a Lyme rash, also known as an erythema migrans, greater than 5 cm in endemic areas. These samples are part of the Lyme Disease Biobank (LDB), which was founded to catalyze new research in the understanding, diagnosis and treatment of Lyme disease and other tick-borne infections. Samples are available for research use through an application process to scientists who already work in tick-borne infections, as well as those new to the field.

“For an epidemic like Lyme disease that is growing at such an alarming rate, there needs to be more research, greater understanding, better diagnostics, and improved treatments,” said Charles Chiu, MD, PhD, Professor of Laboratory Medicine and Medicine, Division of Infectious Diseases, University of California, San Francisco, and Bay Area Lyme Foundation scientific advisory board member, who is currently using samples from the Lyme Disease Biobank for his research. “This study draws attention to the fact that we simply don’t have an accurate test for Lyme disease at present, and this is exactly why clinicians still need to rely on their knowledge of the signs and symptoms of early Lyme disease to diagnose patients and provide prompt treatment.”

These findings also reinforce that Lyme disease does occur in individuals who do not have a erythema migrans, and those with rashes smaller than 5 cm. Samples that were laboratory confirmed for Lyme disease (N=82) were more likely to be enrolled with a Lyme rash (83%) and more likely to present with a Lyme rash greater than 5 cm (74%). However, 26% of laboratory confirmed Lyme disease did not present with a Lyme rash greater than 5 cm, including 9% enrolled as having a Lyme rash smaller than 5 cm and 17% enrolled without any skin manifestations.

“Patients who do not exhibit a rash likely face the greatest challenges in being diagnosed—not only because many healthcare providers specifically look for this sign to diagnose patients, but because the lack of a rash correlated to less likelihood of an accurate serology test, according to this study,” added Dr. Chiu.

Currently comprised of samples from more than 800 participants, the Lyme Disease Biobank utilized 550 patient and control samples (298 cases and 252 controls) collected from 2014 through 2018 for this study. Each sample was tested using both a first tier ELISA and second tier immunoblot (i.e., western blot), and the STTTA was applied. Assays were also performed to detect the presence of tick-borne pathogens (polymerase chain reaction (PCR), and a subset of samples was evaluated by culture. Of the 298 cases enrolled with signs and symptoms of Lyme disease, only 28% were identified as positive for Lyme disease through these methods, or a modified two-tier testing algorithm, consisting of two positive ELISAs in patients with Lyme rash (erythema migrans) greater than 5 cm. This collection highlights and reinforces the known limitations of STTTA testing in early Lyme disease.

“This study highlights the limitations of available tools for all healthcare providers whose patients may be infected with Borrelia burgdorferi, the bacteria that causes Lyme disease. Our hope is that healthcare providers will consider these findings when evaluating patients with signs and symptoms of early Lyme disease,” said Liz Horn, PhD MBI, the study’s lead author and principal investigator for Lyme Disease Biobank. “Our original goal was to characterize the samples we were making available to investigators working on new diagnostics for Lyme disease. We didn’t expect to find such large inaccuracies in current laboratory tests that support clinical decision-making.”

According to findings, participants presenting with a Lyme rash greater than 5 cm were more likely to be positive by any serologic test. For samples taken while patients were experiencing signs and symptoms of early Lyme disease, a positive ELISA was found in 38-43% of patients with Lyme rashes larger than 5 cm, 17-35% of patients with rashes smaller than 5 cm, and 15-27% of patients without a rash, while 5-11% of controls also received a positive ELISA (ranges represent percent positive using different first-tier tests). For the second tier immunoblots, more cases were positive for IgM than IgG (as would be expected for early Lyme disease).

“We are thrilled to see the Lyme Disease Biobank helping to uncover the critical challenges facing patients and physicians as well as the urgent need for more accurate Lyme disease diagnostics,” said Alex Cohen, President and Co-founder of the Steven & Alexandra Cohen Foundation, whose funding has been instrumental in the rapid expansion of the Lyme Disease Biobank over the past four years.

Currently, there are 50 research projects in the U.S. that rely on Lyme Disease Biobank samples.

About Lyme Disease Biobank
The Lyme Disease Biobank (LDB), a program of the Bay Area Lyme Foundation, is a non-profit organization working to accelerate research of Lyme disease and other tick-borne infections. With a collection of biological samples from more than 800 participants, including serum, blood, urine and tissue, LDB provides much-needed samples to researchers working to better understand tick-borne diseases and develop improved tests and therapeutics. Blood and urine samples are collected from the Northeast and Upper Midwest areas of the U.S., as well as the San Francisco area and, now, San Diego, and tissue samples are collected throughout the U.S.

Healthcare providers, and patients interested in donating blood, urine or tissue samples can learn more here.

Researchers interested in obtaining samples should visit www.lymebiobank.org or contact info@lymebiobank.org.

About Lyme Disease
The most common vector-borne infectious disease in the country, Lyme disease is a potentially disabling infection caused by bacteria transmitted through the bite of an infected tick to people and pets. If caught early, most cases of Lyme disease can be effectively treated, but it is commonly misdiagnosed due to lack of awareness and unreliable diagnostic tests. There are more than 400,000 new cases of Lyme disease each year, according to statistics released in 2018 by the CDC. As a result of the difficulty in diagnosing and treating Lyme disease, more than one million Americans may be suffering from the impact of its debilitating long-term symptoms and complications, according to Bay Area Lyme Foundation estimates.

About the Cohen Lyme & Tickborne Disease Initiative
The non-profit organization, the Steven & Alexandra Cohen Foundation, is leading the fight against Lyme and tickborne diseases by educating health professionals, sharing new knowledge, advancing research, accelerating market solutions, and advocating the highest quality care for patients. It advances academic science, creates educational tools and platforms, communicates the latest information and study findings, supports policies that promote the highest quality patient care, strengthens the pipeline of tickborne disease specialists and other health professionals, and focuses on addressing health disparities. The Foundation also collaborates with the U.S. government as well as patient, health, and science professionals and other organizations to further mutually shared goals, including greater awareness of Lyme and tickborne diseases. To learn more, please visit steveandalex.org.

About Bay Area Lyme Foundation
Bay Area Lyme Foundation, a national organization committed to making Lyme disease easy to diagnose and simple to cure, is a leading public not-for-profit sponsor of innovative Lyme disease research in the U.S. A 501c3 non-profit organization based in Silicon Valley, Bay Area Lyme Foundation collaborates with world-class scientists and institutions to accelerate medical breakthroughs for Lyme disease. It is also dedicated to providing reliable, fact-based information so that prevention and the importance of early treatment are common knowledge. A pivotal donation from The LaureL STEM Fund covers overhead costs and allows for 100% of all donor contributions to Bay Area Lyme Foundation to go directly to research and prevention programs. For more information about Lyme disease or to get involved, visit www.bayarealyme.org or call us at 650-530-2439.

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Bay Area Lyme Foundation Highlights 2019 Progress toward Diagnosing, Treating and Preventing Lyme Disease

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Tara DiMilia, 908-947-0500, tara.dimilia@TMstrat.com

Bay Area Lyme Foundation Highlights 2019 Progress toward Diagnosing, Treating and Preventing Lyme Disease

Bay Area Lyme Foundation has now funded more than 100 research projects at 38 institutions around the country since its inception in 2012

PORTOLA VALLEY, Calif., December 13, 2019—Bay Area Lyme Foundation, a leading sponsor of Lyme disease research in the U.S., today announced an exceptional year in research, including the first published studies using samples from the Lyme Disease Biobank and advances in research of disulfiram for treating individuals suffering from chronic Lyme disease and chronic babesiosis, an approach that Bay Area Lyme Foundation was the first to support.

“2019 was met with tremendous forward momentum for Lyme disease research as some of the early research we supported began to show significant clinical impact,” said Linda Giampa, executive director, Bay Area Lyme Foundation. “The Foundation continues to demonstrate progress against tick-borne diseases, one of the most important health crises of our time.”

Journal of Clinical Microbiology Publishes First Study Using Samples from the Lyme Disease Biobank

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Journal of Clinical Microbiology Publishes First Study Using Samples from the Lyme Disease Biobank

More Than 40 Research Projects Have Now Used Samples from Bay Area Lyme Foundation’s Lyme Disease Biobank

PORTOLA VALLEY, Calif., Oct. 15, 2019 /PRNewswire/—Bay Area Lyme Foundation, a leading sponsor of Lyme disease research in the U.S., today announced that a study published in the Journal of Clinical Microbiology reports a potential new diagnostic, mChip-Ld, which can be performed in 15 minutes in a physician’s office, offers efficacy improvement over the current gold standard diagnostic, the two-tier test, and may be able to identify a patient’s Lyme disease stage. The research study, which was funded by the National Institutes of Health, was made possible, in part, by blood samples provided by Bay Area Lyme Foundation’s Lyme Disease Biobank (LDB). LDB is a program of Bay Area Lyme Foundation (BAL), and is supported by donations from multiple sources including the Steven & Alexandra Cohen Foundation.

“Our research toward developing rapid diagnostic assays for Lyme disease is impossible to carry out without having access to laboratory confirmed physician-characterized blood samples,” said study author Maria Gomes-Solecki, DVM, associate professor at The University of Tennessee Health Science Center. “In the past, a limited set of well-characterized Lyme disease samples could be obtained from the CDC. The BAL Lyme Disease Biobank provides another much-needed option in that regard.”

Bay Area Lyme Foundation Tick Testing Program Adds Bartonella Pathogen Assay

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Bay Area Lyme Foundation Tick Testing Program Adds Bartonella Pathogen Assay

Nationwide Free Tick Testing Initiative Will Inform Citizen-Science Studies to Better Understand the Spread of Ticks Carrying Diseases Throughout U.S.

Silicon Valley, CA, July 11, 2019 — Bay Area Lyme Foundation, a leading sponsor of Lyme disease research in the U.S., today announced the relaunch of its nationwide free tick testing program, which will include an assay for Bartonella, a disease-causing pathogen carried by ticks. Based on the success of the Free Tick Testing Citizen Science program, Bay Area Lyme Foundation has significantly increased funding for the 2019 nationwide collection effort, adding an automated submission process and increased research support. Researchers anticipate this citizen- science program will enable the organization to unearth further discoveries.

Results of the first citizen-scientist study were published in the peer-review journals PLOS ONE in 2018, and International Journal of Health Geographics in 2019. The study, which evaluated the prevalence of disease-carrying ticks throughout the United States, and included a massive sample of more than 16,000 ticks collected from 49 U.S. states and Puerto Rico, led to the discovery of ticks capable of carrying Lyme and other tick-borne diseases in 83 counties, in 24 states, where these ticks had not been previously recorded. The program received a six-fold increase in tick submissions over initial estimates, representing unprecedented national coordination of a ‘citizen science’ effort and diagnostic investigation.

Call for Entries for the Bay Area Lyme Foundation’s 2019 Emerging Leader Award Grant

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Tara DiMilia, 908-947-0500, tara.dimilia@TMstrat.com

 

Grants are designed to inspire new research to address the challenges of Lyme disease

PORTOLA VALLEY, Calif., January 15, 2019—Bay Area Lyme Foundation, a leading sponsor of Lyme disease research in the US, is announcing a call for entries for their 2019 Emerging Leader Awards (ELA), which are designed to encourage promising scientists who embody the future of Lyme disease research leadership in the US. This year, two $100,000 grants will be awarded in May. Recipients will be researchers from academia or the private sector who are currently at the post-doctoral through the assistant professor level or equivalent, and who have demonstrated professional and scientific leadership in the biomedical sciences. They should have a defined approach that offers scientific rationale for a research project that can advance diagnostics or treatments for Lyme disease. Proof of concept for the $100,000 awards should be feasible in 12–18 months.

These awards, along with other Bay Area Lyme Foundation efforts, aim to fill a gap as the National Institutes of Health (NIH) funding for Lyme disease research is insufficient. While there are nearly 10 times as many people diagnosed each year with Lyme than HIV in the US, Lyme disease receives approximately 1% of the public funding that is allocated for HIV/AIDS.

Research Supported by Bay Area Lyme Foundation Shows Lower Immune Response Leads To Persistent Lyme Disease Symptoms

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Peer-reviewed Journal Frontiers in Immunology Publishes Important New Research From a Team Led by Bay Area Lyme Foundation’s First Emerging Leader Award Recipient

PORTOLA VALLEY, CA, August, 2018 — Bay Area Lyme Foundation, a leading nonprofit funder of innovative Lyme disease research in the US, today announced the publication of new data that offer valuable insights into the role of the immune system in fighting acute Lyme disease.

The data demonstrate a correlation between initial activation of specific components of the immune response, and a patient’s ability to recover following 21 days of doxycycline. Published in Frontiers in Immunology, the research, primarily funded by the Bay Area Lyme Foundation, was led by Lisa K. Blum, Ph.D., a former postdoctoral scholar at the Stanford University School of Medicine. Blum was one of the first recipients of the Bay Area Lyme Foundation Emerging Leader Award, a grant designed to support the research of promising scientists into Lyme disease and the bacteria that causes it, B. burgdorferi. 

“This research addresses one of the ongoing mysteries of Lyme disease, providing important evidence toward understanding why some people get better after a 21-day course of doxycycline, and some remain sick,” said Wendy Adams, research grant director, Bay Area Lyme Foundation. “The insights from this study not only show that both a competent immune response AND antibiotics are necessary to rid the infection, but also point us toward research avenues that could lead to new therapeutics.”

George Church, Ph.D., Ting Wu, Ph.D., Steven E. Phillips, M.D. and Michal Caspi Tal, Ph.D., Named Recipients of Bay Area Lyme Foundation’s 2018 Emerging Leader Award

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George Church, Ph.D., Ting Wu, Ph.D., Steven E. Phillips, M.D. and Michal Caspi Tal, Ph.D., Named Recipients of Bay Area Lyme Foundation’s 2018 Emerging Leader Award

– Genomics, immunotherapy and unraveling the stealth attributes of Lyme disease are the focus of the 2018 Emerging Leader Award projects, designed to inspire new Lyme disease research –

PORTOLA VALLEY, Calif., May 14, 2018—Bay Area Lyme Foundation, a leading sponsor of Lyme disease research in the U.S., announces the recipients of the 2018 Emerging Leader Awards, which are designed to encourage promising scientists who embody the future of Lyme disease-research leadership. George Church, Ph.D. and Ting Wu, Ph.D. will each be awarded a $250,000 grant to launch the Genomic Lyme Disease Research Initiative project at Harvard Medical School, and Michal Caspi Tal, Ph.D. and Steven E. Phillips, M.D. will each receive $100,000 toward therapeutic research related to immunotherapy and an innovative new drug aimed at eliminating chronic tick-borne infections, respectively. Lyme disease is a potentially devastating infection impacting more than 300,000 Americans each year.

Bay Area Lyme Foundation Awards Grants to Researchers Exploring Novel Ways to Detect, Treat Lyme Disease

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Tara DiMilia, 908-947-0500, tara.dimilia@TMstrat.com

Bay Area Lyme Foundation Awards Grants to Researchers Exploring Novel Ways to Detect, Treat Lyme Disease

Massachusetts Institute of Technology and Brandeis University Researchers are the Awardees of the 2017 Emerging Leader Awards

Portola Valley, Calif., July 11, 2017 – Bay Area Lyme Foundation, the leading national nonprofit funder of innovative Lyme disease research, today announced that the winners of its 2017 Emerging Leader Award, are James J. Collins, PhD, Professor, Massachusetts Institute of Technology and Yuko Nakajima, PhD, Postdoctoral Fellow, Brandeis University. Dr. Collins was awarded a $250,000 grant to research an RNA direct detection diagnostic for early Lyme disease, while Dr. Nakajima received a $100,000 grant to investigate potential treatments to block immune evasion by the bacteria causing Lyme disease.

Bay Area Lyme Foundation’s LymeAid 2017 Raises $850,000 to Boost Lyme Disease Research

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Bay Area Lyme Foundation’s LymeAid 2017 Raises $850,000 to Boost Lyme Disease Research

The event highlights the increasing level of scientific commitment toward Lyme disease and fosters much-needed investment and research in diagnostics and treatments for the disease

Portola Valley, CA (May 22, 2016) – Bay Area Lyme Foundation, the leading public not-for-profit sponsor of innovative Lyme disease research in the US, brought together scientists, philanthropists, celebrities and patients for the fifth annual LymeAid®, an event aimed at making Lyme disease easy to diagnose and simple to cure.  The benefit dinner and concert raised more than $850,000, of which 100% will go directly to fund research for Lyme disease. During the past 5 years, the event has collectively raised $2.4 million specifically for Lyme disease research.

Lyme BioBank: Enabling a New Wave of Lyme Research

nldb-bannerThe national Lyme Disease Biobank (LDB) launched in Summer 2014 after a successful Fund-A-Need campaign at our annual LymeAid benefit. This initiative, which began with a pilot study in East Hampton, NY, a highly concentrated endemic area for Lyme disease, was designed to help address the shortage of clinical samples to support research into better diagnostics and treatments for Lyme disease. The goal is to create a geographically diverse and robust pool of biological samples (particularly blood, but also tissue and other fluids) characterized with sufficient clinical data and validation information about any co-infections that can then be drawn upon by researchers around the country, allowing for more projects to come to fruition. The biobank has already expanded significantly and released the first samples to researchers last year, supporting a new wave of projects.

Liz HornLiz Horn, PhD, MBI, a noted expert experienced in building complex biorepositories and other bio-based technological solutions working with a wide array of researchers, institutions, and other agencies, was brought on as the Principal Investigator for the LDB. Dr. Horn has deep expertise in basic science, cancer biology, bioinformatics, registry questionnaire design, and biobank planning and operations.

We talked with Dr. Horn about the progress they have been making at the Lyme Disease Biobank.