The Lyme Disease Moonshot
Against all odds, Lyme disease activists and nonprofit groups are leading the way for earlier diagnostics. It may yet work.
Kim Collins was a massage therapist at the peak of her talent, beauty, and ambition, when, in 2008, she got Lyme disease. Despite antibiotic treatment, she developed brain lesions, slurred speech, vertigo, joint swelling, and debilitating pain. After two years of decline, she was hospitalized in 2010 for Lyme encephalitis.
Today, Collins, sixty-three, describes herself as “lonely, disempowered, embarrassed” by her disability.
I met Kim a decade ago when I was writing a newspaper series on Lyme disease. As an advocate and friend, I have gone with her to doctors who have been skeptical, derisive, and resistant. I have witnessed what was taken from her by a simple tick bite.
She ultimately had to give up massage therapy. She did not finish nursing school. Her engagement ended. “It was a lost life,” she said.
Kim is among two million Americans who are seldom treated for—let alone cured of—their chronic Lyme disease, because no government-sanctioned test can prove it exists.
The hopeful news, a term I use with caution, is that new technologies are in development to diagnose Lyme disease in patients too long at the mercy of a singularly bad thirty-year-old test that fails both early and late in the disease.
Scientists who reviewed seventy-eight studies of its performance “could not provide sufficient evidence . . . about the value of the tests.” Others concluded “delayed diagnosis and treatment are a common occurrence.”
Lorraine Johnson, chief executive of LymeDisease.org, has surveyed thousands of late-Lyme patients in a project called MyLymeData. In one study, only 36 percent correctly tested positive. The failure rate of Lyme tests, another found, is 170 to 500 times higher than for HIV.
“Without breakthroughs in testing,” Johnson told me, “countless patients will remain undiagnosed, untreated, and condemned to needlessly suffer from persistent Lyme disease.” A better early test would help prevent that.
In one penultimate test failure, Joseph Elone returned sick from summer camp in July, 2013. He tested negative on the Lyme test and was not treated. The bacterium invaded his heart, and on an August evening he collapsed on his front lawn as his father and brother cooked dinner on the backyard grill. He died just after midnight on his mother’s birthday, of Lyme carditis.
He was a seventeen-year-old casualty of a test his pediatrician trusted.
Doctors still do.
Obstacles and hope
In perhaps two to three years, one or more FDA-cleared tests may diagnose Lyme disease quickly, from just after a tick bite to months or even years later. Eventually, a test may show what treatments quell chronic Lyme disease by tracking microbiome markers, newly identified as unique to long-standing infection.
This may sound pie-in-the-sky to long-suffering patients whose lives have been shattered by a wrong or belated Lyme diagnosis. And indeed, impediments remain.
First and foremost: Money. I asked ChatGPT to compare federal research spending for Lyme disease compared to other infectious diseases. “Significantly less,” it said. I checked National Institutes of Health funding: $3.2 billion for HIV/AIDS in 2023; $495 million for tuberculosis; $364 million for hepatitis; $244 million for malaria.
Lyme disease? $43 million.
For that, blame a scandalous lack of government urgency for a disease that infects more than a half million Americans a year—an increase of 70 percent in 2022 from the late 2010s—and leaves 10 to 20 percent sick for months, years, or lifetimes.
Against all odds, Lyme disease activists and nonprofit groups are leading the way. Their efforts and money, including $102 million from the Steven & Alexandra Cohen Foundation, have spurred what is being called a “Lyme diagnostics moonshot.” It may yet work.
The U.S. Department of Health and Human Services launched LymeX in 2020, awarding prizes for research toward the next generation of Lyme diagnostics. The public-private partnership, entirely funded by Cohen, has given $3 million so far; $2 million more will be awarded this month of $10 million pledged.
As a leading data scientist in HHS, Kristen Honey oversaw the launch in 2017 of a Tick-borne Disease Working Group that in six years documented the medical and government lapses that left Lyme patients sick. A co-founder of LymeX along with the Cohen Foundation, she predicts breakthroughs in testing.
“These precision diagnostics,” she told me, “will accurately diagnose all stages of Lyme disease and validate patients’ experiences with this complex, chronic illness.”
Moreover, she said, “Historical controversies surrounding Lyme disease are being untangled—and will be resolved—by LymeX innovators and emerging technologies.”
That’s the Holy Grail for many people like Kim Collins.
Elusive and insidious
In research for my book, I asked a scientist at UC Davis to describe Borrelia burgdorferi, the organism that causes Lyme disease. “Borrelia is a really, really interesting microorganism,” Emir Hodzic told me in almost reverential terms. “It has a huge brain. It outsmarts people.”
Indeed, the Lyme bug changes shape and goes temporarily dormant under environmental stress. It tolerates antibiotics that were thought to obliterate it. It multiplies slowly, making it difficult to culture. While ticks are easy to find in meadows, trailsides, backyards, and dunes from coast to coast, the bacteria it imparts is famously elusive. It’s not for nothing that LymeX is called a “moonshot.”
Competing scientists—from Tufts, Northwestern, Drexel, Massachusetts General Hospital, BlueArc Biosciences Inc., and HelixBind Inc.—are coming up with clever, ingenious, and even far-fetched ways to capture Borrelia or its imprint.
Tufts is hoping to measure “antiphospholipid antibodies,” which are produced earlier in infection, intriguingly, after Borrelia scavenges a fat from its host (the lipid). That would allow for correspondingly earlier testing.
Northwestern is looking for something called peptidoglycans, which are shed by the organism, causing inflammation. Drexel researchers are attempting to track the levels of a type of blood protein, called IgG N-glycan, that increases from healthy to diseased states.
All of these ideas are in the conceptual stages, and, while promising, no test trials have yet been conducted. But other new technologies are also in development.
One nonprofit group, Focus on Lyme, funded research that used machine learning to screen millions of proteins and antibodies in blood samples, identifying key markers of Lyme disease. Developed in collaboration with Tulane University, the resulting test, called LymeSeek, successfully picked up Lyme disease in more than 90 percent of blood samples from validated Lyme-positive patients even during the first few weeks of infection. That’s far better than the standard test.
Another test concentrates minute Borrelia-related proteins in urine—in what’s called a “Nanotrap”—offering direct evidence of infection before the inflammation cascade typical of Lyme illness. The commercially available test “was strongly linked to concurrent active symptoms,” researchers wrote, diagnosing 96 percent of cases with a Lyme rash and 41 percent with post-treatment symptoms.
In their favor, the LymeSeek and the Nanotrap tests can be performed with equipment common in nationwide, high-volume laboratories like Quest and Labcorp. The two lab giants are helping LymeX teams understand the operational demands of clinical laboratories so that new testing technology will be accessible and affordable.
Indeed, many hurdles must be jumped before a Lyme test gets to market, including basic research, test development, clinical trials, commercial laboratory and insurer support, and FDA clearance.
Opening up the competition
“LymeX has been a game changer for legitimizing the need for better Lyme testing,” said Amanda Elam, president of Galaxy Diagnostics, which developed the Nanotrap.
She and Holly Ahern, co-founder of Aces Diagnostics, the LymeSeek developer, said the support given to LymeX teams could also help their efforts. (Some Lyme advocates have asserted that Galaxy was wrongly eliminated from LymeX, which is judged by a panel that includes scientists who have long embraced the status quo.)
Although Aces has made significant progress, including proving its test in clinical trials, “We could still use LymeX support,” said Ahern, which would avoid having to hire costly consultants. LymeX acknowledged this need and told me the competition would be open to qualifying teams in its next phase.
Said Honey, the HHS official. “I’m excited about the next generation of diagnostics, both in and outside the LymeX pipeline.”
Reliable diagnostic tests are standard for HIV, hepatitis, chlamydia, gonorrhea, streptococcus, and so on. This luxury has eluded Lyme disease for a reason. Influential physician-researchers who published early on the test and have access to top-tier journals have repeatedly dismissed or minimized the test’s flaws.
They have focused on the inconsequential issue of over-diagnosis—which may entail a harmless round of antibiotics—and ignored under-diagnosis, which scars for life. They have insisted Lyme treatments work, despite evidence of the organism in laboratory primates that were intentionally infected and treated, and despite evidence in autopsy tissues (including brains) of chronic Lyme patients who got every recommended treatment.
The Centers for Disease Control has given doctors undeserved reason to trust the test (including a marginally better update in 2019) even while acknowledging that a huge swath of America suffers after diagnosis and treatment.
“We’re still using the same diagnostics and treatments from thirty years ago,” Bennett Nemser, the Cohen Foundation’s program officer, said in a 2024 podcast, noting the test relies on a human antibody response that takes roughly four weeks to mount. “Obviously, as a clinician, that’s the exact time you want to be treating someone appropriately, right after a tick bite.”
The problem, ChapGPT sagely told me in explaining pitiful Lyme funding, is too few people die. Lyme is “less widespread and deadly . . . It also has lower mortality rates.”
That’s true to a point. The treatment failure rate is blithely accepted even by the CDC, but little is known of the death and disability toll from Lyme disease.
Mary Jane Heppe, seventy, of Hood River, Oregon, failed the two-tier Lyme test in Virginia in 1999 and in Oregon in 2004, testing positive on the first part, then negative on the second. Seen by numerous doctors, she was instead diagnosed with “fibromyalgia, MS, hip pain syndrome, arthritis, hormonal imbalance, you name it,” she said.
“Severely ill, physically incapacitated, psychotic, and near death,” Heppe told me she was finally diagnosed in January 2005 by an alternative Lyme practitioner. She received repeated rounds of intravenous and oral antibiotics. The suicidal thoughts ended as did the year she spent bedridden.
She is grateful to have found help. She lifts weights, sleeps well, and is off antibiotics. “I’ve been in very good health,” she said.
Many chronic Lyme patients, who cannot afford the care Heppe got, cannot say the same.
The price paid: ‘Even death’
I asked Ben and Diane Elone for their thoughts on the falsely negative Lyme disease test that took their son Joseph from them, as much as the illness itself did.
“We feel there is excessive reliability on a test that is known to be very unreliable,” they wrote in an email. “There doesn’t seem to be sufficient weight on the circumstances surrounding the patients’ incidents, such as activities leading up to and surrounding the illness, and symptoms of illness that are not otherwise explained.
“There seems to be an unreasonable fear of overprescribing antibiotics, but we feel the risk of not doing so may result in serious medical issues and even death.”
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Has anyone tried ivermectin and Fenbenzadole?
You might check out Dr. Robert Yoho's substack on ClO2, a suppressed treatment that some have had luck with Lyme disease. Dr. Pierre Kory and Scott Marsland have also brought it up in their writings.