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

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

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.

# # #

Contact:
Tara DiMilia
908-369-7168
Tara.dimilia@tmstrat.com

Seven Herbal Medicines Are Capable of Killing Lyme Disease Bacteria, According to New Lab Study

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

Seven Herbal Medicines Are Capable of Killing Lyme Disease Bacteria, According to New Lab Study

Research Supported by Bay Area Lyme Foundation Evaluates Anti-microbial Effects of 14 Natural Products Compared to Antibiotics Used to Treat Lyme Disease

Marin, CA, February 21, 2020—Bay Area Lyme Foundation, a leading sponsor of Lyme disease research in the U.S., today announced the publication of new data finding that seven herbal medicines are highly active in test tubes against B. burgdorferi, the bacteria that causes Lyme disease, compared to the control antibiotics, doxycycline and cefuroxime. Published in the journal Frontiers in Medicine, the laboratory study was funded by the Bay Area Lyme Foundation and supported in part by The Steven & Alexandra Cohen Foundation. The study was a collaboration between researchers at Johns Hopkins Bloomberg School of Public Health and colleagues at the California Center for Functional Medicine and FOCUS Health Group, Naturopathic.

“Since traditional antibiotic approaches fail to resolve symptoms in up to 25% of patients treated for Lyme disease and many suffer disabling effects of the disease, there is a need for novel treatment proven effective against B. burgdorferi,” said the paper’s co-author Sunjya K. Schweig, MD, CEO and co-director, California Center for Functional Medicine and Scientific Advisory Board Member, Bay Area Lyme Foundation. “Because patients are currently turning to herbal remedies to fill the treatment gaps left by antibiotics, this research is a critical step in helping clinicians, as well as patients, understand which ones may offer the most potential benefit.”

According to this laboratory study, carried out by Prof. Ying Zhang’s group at the Johns Hopkins Bloomberg School of Public Health, the seven herbal medicines that have the ability to kill B. burgdorferi in test tubes are:

  • Cryptolepis sanguinolenta
  • Juglans nigra (Black walnut)
  • Polygonum cuspidatum (Japanese knotweed)
  • Artemisia annua (Sweet wormwood)
  • Uncaria tomentosa (Cat’s claw)
  • Cistus incanus
  • Scutellaria baicalensis (Chinese skullcap)

It is important to note that each of these products have the potential to produce significant side effects in patients, and should be taken only under advisement of a clinician knowledgeable of their capabilities and toxicities.

Of these products, the Cryptolepis sanguinolenta extract caused complete eradication, while doxycycline and cefuroxime and other active herbs did not. This extract has been used for the treatment of malaria as well as the tick-borne infection Babesia, a malaria-like parasite. This study is believed to be the first time this extract has been documented to have a potential impact on B. burgdorferi, and additional laboratory and clincial studies should be conducted to investigate the potential role Cryptolepis sanguinolenta could play in the treatment of Lyme disease.

Further, Cryptolepis sanguinolenta and Polygonum cuspidatum (Japanese knotweed) showed strong activity against both growing B. burgdorferi (MIC=0.03%-0.06% and 0.25%-0.5% respectively) and non-growing stationary phase B. burgdorferi.

In contrast, Stevia rebaudiana, Andrographis paniculata, Grapefruit seed extract, colloidal silver, monolaurin, and antimicrobial peptide LL37 had little or no activity against stationary phase B. burgdorferi.

“Our hope is that findings from this study could point to new therapeutic options for doctors and their patients, and pave the way for clinical research to help patients with persistent Lyme disease,” said Linda Giampa, executive director, Bay Area Lyme Foundation.

These data may provide a basis for the clinical improvement of patients who take herbal medicines, particularly those whose chronic symptoms may be due to persistent bacteria that are not killed by conventional Lyme antibiotic treatment. However, it is critical to note that additional studies are needed to further evaluate the seven active botanical medicines identified in the study. Patients should not attempt to self-treat with these herbal medicines due to potential side effects and lack of clinical trials with these products.

About the Study
For the study, the researchers tested 14 natural products in test tubes against B. burgdorferi. Plant extracts selected for the study included herbs or agents that: have been previously used to manage the symptoms of patients who do not respond to standard Lyme antibiotic treatment; have favorable safety profiles; and can be absorbed systemically. Additional criteria for selecting compounds included anti-biofilm effects and ability to cross the blood-brain barrier. To conduct the study, the plant extracts in concentrations of 1%, 0.5% and 0.25% and antibiotic controls were each tested on growing as well as non-growing B. burgdorferi cultures. The study found that seven of these natural product extracts at 0.25%-0.5% had better activity against the stationary phase B. burgdorferi culture than the control antibiotics doxycycline and cefuroxime, both of which are commonly used to treat Lyme disease.

The paper titled “Evaluation of Natural and Botanical Medicines for Activity against Growing and Non-growing Forms of B. burgdorferi,” was written by Jie Feng, PhD, Jacob Leone, ND, Sunjya Schweig, MD, and Ying Zhang, MD, PhD.

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, at least two 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 advance 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.

# # #

Contact:
Tara DiMilia
Phone: 908-884-7024
Tara.DiMilia@tmstrat.com

Evaluating the Success of Hyperthermia Treatment in Chronic Lyme Disease

Guest Post from
Michelle McKeon, MS
President, Lyme and Cancer Services

Bay Area Lyme is happy to share the editorial contributions of care providers, patients, caregivers, and others in the community who are eager to share their knowledge for the benefit of others suffering from Lyme and related tick-borne illnesses. There is still so much we don’t know and so much we are just learning. It is critical that we keep an active dialogue and share and collaborate to continue to move our understanding forward. What follows is an article written by a guest contributor and practicing care provider who shares that view and her personal and professional experience in  hopes that it can help others with their healing journeys.

First West Coast CME Program on Tick-borne Disease Provides New Data, Insights from Researchers

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

 

First West Coast CME Program on Tick-borne Disease Provides New Data, Insights from Researchers

Stanford University School of Medicine and Massachusetts General Hospital host clinical and research forum funded by Bay Area Lyme Foundation

Silicon Valley, CA, September 3, 2019—Bay Area Lyme Foundation, a leading sponsor of Lyme disease research in the U.S., today highlights the first tick-borne disease CME program on the West Coast, Emerging Research, Diagnosis and Treatment of Lyme Disease and Tick-Borne Illness. The conference was hosted by two major academic institutions representing the East and West Coasts of the U.S., Stanford University School of Medicine and Massachusetts General Hospital, and included presentations related to the magnitude of tick-borne disease in California, emerging diagnostic technologies, potential future treatment options, and epidemiological statistics enabled by Lyme disease biobanks.

“There is a lack of understanding about the variety and severity of tick-borne illnesses such as Lyme disease on the west coast” said Charles Chiu, MD, PhD, professor of laboratory medicine and infectious diseases at UCSF, associate director of the UCSF Clinical Microbiology Laboratory, and Bay Area Lyme Foundation Scientific Advisory Board member. “This was a great opportunity to share the latest findings and ongoing research on the topic, so that physicians and other medical professionals can more quickly and accurately diagnose and treat their patients.”

In Search of a Cure for Lyme Disease: The Disulfiram Story

– Bonnie Crater, founder and vice-chair of the Board of Directors, Bay Area Lyme Foundation

What does an anti-alcoholism drug have to do with Lyme disease? Nothing—until a 2016 study funded by Bay Area Lyme Foundation found a link. From around 2014 through 2017, two labs on opposite coasts—one at Johns Hopkins University and one at Stanford—were testing thousands of FDA-approved drugs to identify an existing drug that worked against “persister” forms of Borrelia burgdorferi (Bb), the bacteria that causes Lyme disease(1,2,3,4). Why were they doing this?

Here’s a little background. Borrelia burgdorferi, a spirochete, when cultured in a lab has roughly 3 different forms: a) a culture with predominantly long or corkscrew forms, b) a culture with predominantly round forms and some microcolonies, and c) a culture with predominantly microcolonies (2). Most laboratory studies regarding the effectiveness of antibiotics are conducted in cultures on long forms. In this long form, the spirochete is motile and can divide (although very slowly) and consequently, some antibiotics work much better on the long form. However, after exposure to antibiotics such as doxycycline, the spirochete curls up into a round form and some clump together with other spirochetes to form a few microcolonies. These round-body and microcolony forms are understood to be a defensive posture for the bacteria.

One Success Hurts Thousands Who Are Suffering

Bay Area Lyme Foundation Responds to NY Times Story

We are thrilled for the Mandavilli family, who shared that their son responded well to treatment for Lyme disease in The New York Times story My Son Got Lyme Disease. He’s Totally Fine. This is not the case for everyone, and it is irresponsible, and scientifically inaccurate, to blanketly define Lyme, and other tick-borne diseases, as “easily treated”. This one patient’s experience can be countered by hundreds of other patients whose disease has brought their lives to a halt. It does a huge disservice to patients whose families read stories like this and question the patient’s symptoms, and whose community doctors see reports like this and refuse much-needed treatment. The joy of the Mandavilli family should be heralded as a success but not an example.

The CDC has reported deaths due to Lyme disease beginning as early as 2013, with most caused by Lyme carditis, a condition in which the bacteria invades the heart. And, the ability of this bacteria to invade other organs, including the brain, and cause paralysis is well-documented. Several celebrities including Alec Baldwin, Avril Lavigne, Yolanda Hadid and Kelly Osborne have by their own accounts believed that they were near death due to Lyme disease. Clearly, the singular experience of the Mandavilli family is not broadly representative of what every person with Lyme experiences.

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

FOR IMMEDIATE RELEASE

Media Contact:
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.

Bay Area Lyme Foundation Endorses First Recommendations of New HHS Working Group Focused on Tick-Borne Diseases

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

 

The Foundation encourages Congress to support the recommendations to fund efforts to increase scientific understanding of Lyme disease and other tick-borne infections

Portola Valley, Calif., November 14, 2018—Bay Area Lyme Foundation, a leading sponsor of Lyme disease research in the United States, offered their appreciation to the U.S. Department of Health and Human Services (HHS) in response to The Tick-Borne Disease Working Group’s recommendation for increased Federal investment focused on Lyme disease awareness, education, diagnosis and treatment. This Federal Advisory Committee was enshrined in the 21st Century Cures Act, after years of work by Lyme disease advocates and their congressional representatives to review the Federal Government’s activities on tick-borne disease.

“This document represents an important first step by the U.S. federal government to recognize the need to better address tick-borne diseases,” said Wendy Adams, Research Grant Director, Bay Area Lyme Foundation and Member, Tick-Borne Disease Working Group.  “These recommendations make the powerful point that significant increases in federal government funding for tick-borne disease research are required before we can truly diagnose and treat tick-borne infections.”

While there are nearly 10 times as many people diagnosed each year with Lyme than HIV in the U.S., Lyme disease receives approximately 1% of the public funding that is allocated for HIV/AIDS.

Bay Area Lyme Foundation and Project Lyme Join Forces to Fight Lyme Disease at the 2018 Lyme Gala

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

 

Event Raises Awareness, and $1.4 Million for Research Related to Lyme Disease and other tick-borne illnesses, which can potentially be disabling, and even life-threatening

New York, NY, November 6, 2018 – Bay Area Lyme Foundation and Project Lyme, two organizations committed to halting the course of Lyme disease, came together to highlight the need for collaboration in the fight against Lyme during the inaugural 2018 Lyme Gala. The collaboration aims to improve awareness, education, and research of Lyme and other tick-borne infections, which can potentially be disabling, and even life-threatening. With Bay Area Lyme Foundation’s expertise working with scientists and institutions to implement valuable research, develop impactful educational programs and create novel initiatives such as the Lyme Disease Biobank, and Project Lyme’s focus on increasing awareness and improving education, these organizations hope to one day make Lyme and other tick-borne diseases easy to diagnose and simple to cure.

“Lyme disease is the most important health crisis of our time,” said 2018 Lyme Gala honoree, Bill Ford, CEO, General Atlantic. “This disease demands that we recruit and fund the best medical minds to fund a cure, and I am hopeful of the efforts of Project Lyme and Bay Area Lyme Foundation toward this goal.”

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

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

 

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.”