Archive for the ‘Lyme’ Category

Two Tests Outperform Current Tests for Detecting Early Lyme Disease

https://www.bayarealyme.org/blog/journal-of-clinical-microbiology-studies-demonstrate-two-investigational-diagnostics-outperform-current-tests-in-detecting-early-lyme-disease/

Journal of Clinical Microbiology Studies Demonstrate Two Investigational Diagnostics Outperform Current Tests in Detecting Early Lyme Disease

Journal of Clinical Microbiology Studies Demonstrate Two Investigational Diagnostics Outperform Current Tests in Detecting Early Lyme Disease
 | Diagnostics, NewsBy 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.

“Improving diagnostics for early Lyme detection is critical to reducing missed cases and enabling patient access to treatment when it is most effective, helping prevent disease progression,” said Pete Gwynne, PhD, Research Assistant Professor of Molecular Biology and Microbiology at Tufts University School of Medicine. “The use of Lyme Disease Biobank samples to validate this research highlights the important role biorepositories can play in innovative science.”

InBios’ microarray-based assay is designed to capture reactivity against a set of 10 different Borrelia burgdorferi antigens simultaneously including VlsE and multiple OspC variants, and it uses machine learning to analyze results, identifying complex patterns.

“The Lyme Detect Multiplex ELISA offers a significant improvement in early Lyme detection while simultaneously providing important independent IgG and IgM antibody reactivity against a broad panel of targets,” said James Needham, PhD, Director of New Product Development at InBios International.

Another recent independent study published in the Journal of Clinical Microbiology in August found Kephera Diagnostics’ Hybrid Lyme ELISA demonstrated 94% sensitivity in patients with EM skin lesions, compared to just 64% for STTT and 76% for modified two-tier testing (MTTT). The Hybrid Lyme ELISA likewise outperformed both two-tier methods in detection of EM patients within the first week after onset of symptoms. This single-tier test achieved equivalent specificity to both STTT and MTTT, based on a unique approach that requires antibodies to bind both the Borrelia C6 peptide and the VlsE protein. The test is now in clinical trials to support an FDA submission.

“Our Hybrid Lyme ELISA demonstrates that it’s possible to achieve both high sensitivity and high specificity in a single-tier format, even in the earliest stages of Lyme disease,” said Andrew Levin, PhD, Chief Executive and Scientific Officer of Kephera Diagnostics, who led this study using samples from the Lyme Disease Biobank, the CDC, and New York Medical College. “Access to well-characterized samples was essential to validating this approach and moving the field closer to a reliable, first-line diagnostic for Lyme.”

About Lyme disease
The most common vector-borne infectious disease in the US, Lyme disease is a potentially disabling infection caused by bacteria transmitted through the bite of an infected tick to people and pets, and can be potentially passed from a pregnant mother to her unborn baby. If caught early, most cases of Lyme disease can be effectively treated, but it is commonly misdiagnosed due to lack of awareness and inaccurate diagnostic tests. There are more than 620,000 new cases of Lyme disease each year, according to Bay Area Lyme Foundation estimates. As a result of the difficulty in diagnosing and treating Lyme disease, up to 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 Lyme Disease Biobank
Lyme Disease Biobank (LDB), a program of 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 specimens from more than 1,250 participants, including blood, serum, plasma, urine and tissue, LDB provides much-needed samples to approved researchers working to better understand tick-borne diseases and develop improved diagnostic tests and therapeutics. Blood and urine samples are collected from the Northeast, Upper Midwest and West Coast areas of the US, and tissue samples are collected throughout the country. Researchers interested in obtaining samples should visit www.lymebiobank.org or contact info@lymebiobank.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 the leading public charity sponsor of innovative Lyme disease research in the US. A 501c3 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. Historically, a pivotal donation from the LaureL STEM fund covered all overhead costs through 2024. In 2023, a Bay Area Lyme Endowment was formed, which allows for 100% of all donor contributions to the Bay Area Lyme Foundation to go directly to research and prevention programs in perpetuity. For more information about Lyme disease or to get involved, visit www.bayarealyme.org or call us at 650-530-2439.

About InBios
Since 1996, InBios has been a leader in the development of diagnostic tests for emerging infectious diseases and biothreats. Products are designed for superior performance, efficiency and value. These include several FDA market authorized and CE marked assays for arboviruses, parasitic infections, biothreats, and more. InBios continues to anticipate and serve the growing global public health demand. Products in the pipeline include next generation platforms for Chagas, dengue, tick-borne and respiratory diseases. For more information, visit www.inbios.com.

About Kephera Diagnostics
Kephera Diagnostics is a young and growing company that is addressing the public health challenges of global infectious diseases using new assay technologies.  We also operate a CLIA-certified and CAP-accredited diagnostic laboratory delivering excellence in specialized diagnostics. We focus on diagnostic solutions for diseases where there are significant gaps in addressing patient needs, particularly in underserved areas of healthcare including infectious diseases and women’s health. Our mission is to promote more effective and affordable medical treatment through faster diagnosis. We collaborate with a global community of researchers and clinicians to develop and translate new technologies into accessible products for clinical diagnostics and research applications.

# # #

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

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**Comment**

Not sure why Bay Area Foundation is stating that congenital Lyme can potentially happen.  It can happen – period and 33 years of of documentation proves it.

Interesting to note:

“study co-author Gary P. Wormser, MD, New York Medical College said, “This test [Kephera Diagnostics’s Hybrid Lyme ELISA] could potentially change the standard of clinical practice, allowing clinicians to diagnose all manifestations of Lyme disease with a time-saving one-step antibody test.”

Why the Lyme/MSIDS community is still working with Gary Wormser is beyond me.  His track record is clear.

Having a quicker, more accurate test for early Lyme is important, but so is an accurate test for the thousands upon thousands who are chronically infected.

It will be interesting to see what ‘the powers that be’ do with all these new tests coming out. The concerted effort against direct testing or any test that is deemed competition to FDA/CDC testing has been decades in the making.

Category:

Activism, Lyme, research, Testing, Uncategorized

Inside IGeneX’s New Lyme Test

http://  Approx. 55 Min

Inside IGeneX’s Game-Changing Lyme Test

Dr. Jyotsna Shah

Oct 7, 2025
 
Dr. Jyotsna Shah is an immunologist and molecular biologist with over 40 years of experience in diagnostic tools for tick-borne diseases. She holds a Ph.D. in diagnostic immunology from the University of Nairobi and conducted postdoctoral work at Harvard University.
 
Shah joined IGeneX in 1997, becoming Laboratory Director in 2003 and now serving as President and CEO.
_____________
 
**Comment**

Like so many other pioneers who expose inconvenient truths about Lyme, the Michigan State Attorney’s Office told Dr. Lida Mattman to stop testing for Lyme using her gold standard direct culture technique.  She also successfully duplicated the results of the Bowen Q-RiBb test, which provided a preliminary report of the findings within 24 hours of receiving the specimen. The final report included digital photographs of the finding, which was useful in evaluating treatment by comparing pre and post serial dilution results.

Direct testing for Lyme has been attacked for over 20 years.  The CDC has persecuted any test they don’t have control over and get kick backs from.

Mattman was subsequently threatened with time in jail or a fine of 5,000 dollars a day.  State police arrived at her lab with handcuffs and tried to find evidence that she was still testing but they didn’t find what they were looking for. She was forced to stop her valuable work and leave her lab.

The continued adherence to worthless 2-tier CDC testing is on purpose.  They don’t want an accurate test – they’ve had two already and buried them!

I question the use of PCR for diagnosing anything.  Just look at the COVID fiasco due to faulty testing.  Time will tell on this new IGeneX test.

For more:

Despite having nearly every symptom and being ER bound, neither my husband nor I managed to test positively on the CDC’s 2-tiered testing which sets arbitrary limits and omits the most specific band that is sometimes the only marker for those with late-stage Lyme due to decision made in Dearborn, Michigan decades ago.

The most divisive part of the two-step diagnostic standard – now called the Dearborn criteria – was elimination from the Western blot of two Bb proteins, outer surface protein A (OspA), from which LYMErix was made, and outer surface protein B (OspB), the intended component of next-generation vaccines.  Source

 

 

 
 

Category:

Lyme, research, Testing, Uncategorized

Why Millions Are Suffering in Silence: A Global Health Crisis

https://lymecare.org/posts/globalhealthcrisis/

Why Millions Are Suffering in Silence: A Global Health Crisis

The Silent Pandemic: Misdiagnosis and Urgent Lyme Disease Awareness
The Silent Pandemic: Misdiagnosis and Urgent Lyme Disease Awareness

Imagine waking up every morning feeling slightly off—just a bit out of sorts. Sometimes there’s a headache, other times an overwhelming sense of tiredness that even a strong cup of coffee can’t shake. You chalk it up to stress, the inevitable wear and tear of a busy life. But as the months pass, your symptoms worsen. By mid-morning, your energy is drained, and strange, fleeting moments of dizziness and confusion disrupt your routine. You tell yourself it’s nothing serious, probably just burnout. Until, one day, the fog in your mind becomes so dense that you can’t recall simple tasks or details you’ve known your entire life.

Doctors Tell You: It’s All in Your Head

When you finally turn to doctors for help, they dismiss your concerns. They tell you it’s all in your head—that you’re stressed, depressed, or simply overworked. You’re prescribed herbal supplements like valerian and ginkgo biloba, and receive a laundry list of vague diagnoses: fibromyalgia, chronic fatigue syndrome, multiple sclerosis, or worse, psychiatric disorders. The medications don’t help, the tests come back inconclusive, and years pass as you’re left searching for answers. Bit by bit, you start to lose touch with your loved ones, as friends and family struggle to understand the invisible illness consuming your life.

The Inadequate Excuse of Covid

Maybe you had Covid a few months or a year ago, and now doctors insist your lingering symptoms are due to Long Covid. But you know plenty of people who had the virus and are perfectly healthy today, long past their infection. The Covid pandemic, while devastating, has also become a convenient excuse to mask a deeper, more sinister truth.

The Real Cause: A Hidden Infection

All the while, the real culprit—a stealthy bacterial infection called Borrelia—is quietly ravaging your body, undetected by the very healthcare system that should be safeguarding you. And you’re not alone. Millions of people worldwide are suffering in silence, unaware that Borrelia is behind their mysterious ailments.

Despite the severity of the infection, few around you have even heard of Borrelia or understand the damage it can cause. Even the most expensive doctors fail to recognize its effects. (See link for article)

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**Comment**

Part of the reason I don’t write more articles is because I spend a great deal of time correcting articles written by others.  It amazes me to no end how the accepted narrative of Lyme/MSIDS can still remain so pervasive after 40 years.

That said, this well written article only needs an update on some new research.  Since no date is included about when the article was written, but mentioned COVID, we can assume it was written sometime in the past 5 years.

Just this year (2025), a study showed that there is no evidence mosquitoes can transmit Bb, as the bacteria can not survive in their guts long enough to reach their salivary glands to be able to transmit the disease.  A few findings:

  • Mosquitoes exhibited low efficiency in acquiring Borrelia from infected hosts.
  • Spirochetes artificially introduced through ex vivo blood meals were rapidly eliminated during digestion, primarily due to trypsin activity.
  • Inhibition of trypsin prolonged spirochete persistence and infectivity in the mosquito gut. (Which begs the question if this is true for the human gut as well).  Interestingly, in arthropods trypsin increases significantly after blood feeding and plays an important role in early protein degradation.
  • Mechanical transmission experiments revealed no evidence of Borrelia transmission from infected to naive hosts.
  • The study makes the fatal flaw of assuming Ixodes ticks are the SOLE vectors capable of transmitting Lyme disease. There are many other bugs out there that have not been tested for transmission. We also know that human congenital transmission occurs (mother to fetus) and there is much to indicate it can be transmitted sexually as a STD.  It’s important to understand that no studies have ruled out sexual transmission but ‘the powers that be’ continue to proclaim it as fact.

For more:

Others have found various ways Bb is transmitted as well:

Like so many other pioneers who expose inconvenient truths about Lyme, the Michigan State Attorney’s Office told Dr. Mattman to stop testing for Lyme using her gold standard direct culture technique.  She also successfully duplicated the results of the Bowen Q-RiBb test, which provided a preliminary report of the findings within 24 hours of receiving the specimen. The final report included digital photographs of the finding, which was useful in evaluating treatment by comparing pre and post serial dilution results.

Mattman was subsequently threatened with time in jail or a fine of 5,000 dollars a day.  State police arrived at her lab with handcuffs and tried to find evidence that she was still testing but they didn’t find what they were looking for. She was forced to stop her valuable work and leave her lab.

The continued adherence to worthless 2-tier CDC testing is on purpose.  They don’t want an accurate test – they’ve had two already and buried them!

Category:

Lyme, Testing, Ticks, Transmission

Borrelia Miyamotoi DNA in Patient Suspected of Lyme Borreliosis

https://www.aaem.pl/-Borrelia-miyamotoi-DNA-in-a-patient-suspected-of-Lyme-borreliosis

Borrelia miyamotoi DNA in a patient suspected of Lyme borreliosis
Beata Fiecek 1, Tomasz Szewczyk 2, Grażyna Lewandowska 1, Tomasz Chmielewski 1
Ann Agric Environ Med. 2025;32(1):142-145

DOI: https://doi.org/10.26444/aaem/191046

Article (PDF, 771.39 kB)

ABSTRACT
Introduction and Objective.
Manifestations of infection caused by Borrelia miyamotoi can mimic highly variable symptoms of Lyme borreliosis. The aim of the study was to detect DNA from B. miyamotoi samples from patients with suspected neuroborreliosis.
Materials and Method. Samples of blood serum and cerebrospinal fluid (CSF) were collected from 133 patients. Diagnosis was established by the detection of specific antibodies to Borrelia burgdorferi sensu lato (s.l.) with ELISA and immunoblot. All Borrelia-positive samples were tested by nested PCR for the B. miyamotoi and B. burgdorferi s.l. DNA.
Results. B. miyamotoi DNA was detected in the CSF of one (0.8%) patient. DNA of B. burgdorferi s.l. was not found in any samples.
Conclusions. Detection of the B. miyamotoi in patients with central nervous system infections expand the development of knowledge on infections caused by Borrelia spirochetes.
_______________
**Comment**
Just like STARI, B. miyamotoi looks, smells, and feels just like Lyme but will never be picked up on standard CDC 2-tiered testing for Lyme.
While there are both PCR and antibody tests for Borrelia miyamotoi, they are offered at specialty labs which many mainstream doctors just assume are pure evil because that’s what the CDC has beat into their heads for decades.
For more:

“In vitro analysis has shown the susceptibility of B. miyamotoi to ceftriaxone, azithromycin, and doxycycline, with resistance to amoxicillin,” the authors explain.

Since Borrelia miyamotoi is not a reportable illness to the CDC, no one has any clue about prevalence but reports are coming in continually that it’s highly likely to be a much bigger problem than ‘authorities’ believe.

It was recently discovered that:

Category:

Borrelia Miyamotoi (Relapsing Fever Group), Lyme, research, Testing, Ticks

SOT For Lyme: Experimental, Expensive, but Full of Potential

https://www.lymedisease.org/sot-lyme-treatment/

SOT therapy for Lyme is experimental, expensive—and full of potential.

Oct. 3, 2025

Part One of a two-part series.

By Maria Marian, ND, MSE

For many people facing chronic infections such as Lyme disease, Epstein–Barr virus (EBV), herpes simplex virus (HSV-1 and HSV-2), or cytomegalovirus (CMV), the journey can be long and frustrating.

Antibiotics, antivirals, herbal therapies, and IV treatments may help initially, yet symptoms often persist or recur. This has led both patients and clinicians to explore innovative therapies that move beyond conventional antimicrobial approaches.

One such emerging option is Supportive Oligonucleotide Therapy (SOT), also referred to as antisense oligonucleotide therapy. Although still considered experimental in the context of Lyme and chronic viral infections, SOT builds upon decades of genetic medicine research and has even reached FDA approval in select infectious and cancer-related applications.

What is SOT?

At its core, SOT is a gene-silencing technique. Scientists design a short synthetic strand of nucleic acid (called an oligonucleotide) that binds to a very specific piece of genetic code inside the pathogen—such as Borrelia burgdorferi (the bacterium that causes Lyme disease) or EBV.

When this oligonucleotide binds, it blocks the pathogen’s ability to produce a protein essential for replication or metabolism. In simple terms, it’s like removing a crucial page from the pathogen’s instruction manual. Without that instruction, the organism can’t replicate efficiently, and its numbers gradually decline.

This strategy falls under the larger field of “antisense therapy.” The term comes from the fact that these therapeutic molecules bind to the “sense” strand of RNA or DNA, neutralizing its ability to produce proteins.

Reference: Crooke ST. Antisense Drug Technology: Principles, Strategies, and Applications. CRC Press; 2008.

How the therapy works

The process of SOT treatment involves several carefully orchestrated steps:

  1. Blood Draw & Testing – A blood sample is taken and analyzed using molecular techniques such as PCR to identify which pathogens are active.
  2. Custom Design – A laboratory designs a patient-specific oligonucleotide tailored to silence a genetic target in that pathogen. Newer approaches like QRE-strain technology (Quasispecies Resistant Engineered strain) aim to account for genetic variations in pathogens, ensuring the oligonucleotide is effective across slightly different strains.
  3. Infusion – Once prepared, the oligonucleotide solution is returned to the clinic and administered as a single intravenous infusion.
  4. Ongoing Action – Unlike antibiotics or antivirals that are metabolized quickly, SOT molecules remain active for months (often up to six months), continuously working “day and night” to suppress pathogen replication.

The Science Behind It

Antisense oligonucleotides are not a new idea. In fact, the first FDA-approved antisense therapy, fomivirsen (Vitravene), was approved in 1998 to treat CMV retinitis in immunocompromised patients【PMID: 9815174】. Since then, several antisense and RNA-based drugs have reached the market for conditions ranging from high cholesterol (mipomersen) to spinal muscular atrophy (nusinersen)【PMID: 29191460】.

In infectious disease specifically:

  • CMV: Fomivirsen demonstrated that gene-silencing therapy can effectively reduce viral activity in humans.
  • Herpesviruses: Preclinical studies have shown that antisense molecules can block HSV and EBV replication in vitro【PMID: 19920191】.
  • Lyme disease: Pilot clinical data suggest that one or two SOT infusions can lead to statistically significant reductions in Borrelia burgdorferi DNA levels detected by PCR. For viral infections, two or three treatments may be needed to achieve measurable decreases.

While more research is essential, these early findings provide a rationale for SOT as a potential adjunctive therapy in chronic infections where other approaches fall short.

Why patients are interested

For individuals struggling with persistent infections, SOT offers several appealing features:

  • Precision targeting: Instead of broadly killing microbes (as antibiotics do), SOT goes after one critical genetic sequence, leaving other microbes untouched.
  • Durability: A single infusion provides months of activity, reducing the need for daily medication.
  • Immune-independent mechanism: Because SOT directly silences genes, it doesn’t rely on the immune system’s strength—a key advantage for patients with immune dysfunction.
  • Potential synergy: Many clinicians use SOT alongside integrative therapies (nutrition, detoxification, antimicrobials) for a more comprehensive approach.

Current limitations

Despite the excitement, it’s important to emphasize what SOT is not at this stage:

  • It is not FDA-approved for Lyme disease, EBV, or HSV. Its only infectious disease approval was for CMV retinitis, and that drug is no longer commercially available.
  • Clinical research in Lyme and chronic viral infections is preliminary, mostly limited to small pilot studies and case reports.
  • Costs can be significant, and insurance rarely covers it.
  • The decline in pathogen burden is gradual, and multiple treatments may be required.

In short: SOT is promising, but it remains an emerging therapy.

Looking ahead with both hope and caution

The field of RNA medicine is growing rapidly, with antisense oligonucleotides, small interfering RNAs (siRNAs), and messenger RNA (mRNA) therapies transforming the landscape of medicine. With continued research, we may see gene-silencing strategies like SOT become mainstream tools in the fight against chronic infections.

For now, patients and clinicians should approach SOT with both hope and caution—hope that it represents a real step forward in treating persistent pathogens, and caution because large, peer-reviewed trials are still needed to fully establish safety, efficacy, and long-term outcomes.

Part two will be published next week.

Maria Marian, ND, MSE, is a naturopathic physician at Jyzen Wellness in Mill Valley, California. In addition to her Doctorate of Naturopathic Medicine, she holds both a Bachelor and Master of Science in Chemical Engineering. She specializes in complex chronic illness, Lyme disease, and integrative approaches to immune dysfunction. Follow her on Instagram: @dr.marian.nd

For more:

According to both Dr. Ross and Dr. Cameron, it’s still too early to confidently recommend SOT for Lyme/MSIDS.

Category:

Lyme, Treatment, Viruses