Lyme Diagnostics – Changing the Standard of Care

I spent most of my life blissfully unaware of the complexities of Lyme disease. Then, I was introduced in a way that is all too common – it hit my family.

Lyme disease is often associated with a bullseye rash, fever, and joint pain. My husband, Russ, didn’t have any of those symptoms. Instead, he presented with neurological symptoms, including depression, anxiety, mood swings, and cognitive decline. Fortunately, I found links between Lyme and neurological issues in my research on his symptoms. Russ was an avid outdoorsman with multiple tick exposures, so I immediately added it to the list to discuss with his doctor.

But when the doctor tested Russ for Lyme disease, he tested negative. He had only 1 of the 5 bands needed for a positive result. The doctor recommended that we go to a neurologist, and there Russ was given a devastating diagnosis: early-onset Alzheimer’s disease. I was in shock. Russ was only 60 at the time and had no genetic predisposition for Alzheimer’s. He was also declining rapidly, and my engineering background told me there had to be a root cause.

As it turned out, I was right. Fifteen months after our first trip to the doctor, Russ was retested for Lyme. This time, he tested positive for Lyme and two other tick-borne co-infections. Unfortunately, the diagnosis came too late. Russ had advanced to the late stages of his disease and passed away in January of 2022.

Losing Russ first to dementia and then to death brought me to a dark place. His disease shattered everything I thought I knew, and the remaining pieces no longer fit. I knew I needed to pour my energy into driving change and ensuring that those infected in the future don’t experience the chaos of the present.

So, I returned to my engineering roots. Usually, when all seems lost, it’s time to step back and reanalyze the data. When Russ passed, I retired from my role as caregiver and returned to the discipline that had always provided the answers I craved: science.

But science had failed me. Russ tested negative for Lyme in our very first doctor’s visit. Having worked for over 15 years in innovative medical devices and diagnostics, I had to dig in and figure out why.

In my humble opinion, THE biggest problem in Lyme Disease is the current standard of care in diagnostics. A systematic review of thirteen different studies on the CDC-recommended test revealed 49-65% sensitivity across all stages of the disease. This means that a person infected with the bacteria that causes Lyme has a 35-51% chance of testing negative. For those outside the Lyme world, this seems impossible. How can a diagnostic test be about as accurate as a coin flip? But those immersed in Lyme live this harsh reality.

The science behind these poor results is clear. The test looks for antibodies, which peak weeks after the initial infection. This makes the test inappropriate for the earliest stages of infection, precisely when it is the most treatable.

For those in the later, chronic stages of the infection, the immune system is often suppressed. Compromised immune systems don’t produce the same antibody levels and can cause titers to be below detection limits, as was the case for Russ.

Finally, antibody testing is useless for those who have been diagnosed and treated but are still sick. Antibodies identify exposure to a pathogen but cannot establish whether the infection is active. The COVID-19 epidemic was a great crash course in infectious disease diagnostics. A patient will test positive for COVID-19 antibodies if exposed to the virus, but an antigen or PCR test is needed to determine if the patient has the virus right now.

Direct detection of the pathogen is a far better approach to diagnosis. Instead of looking for the immune system’s response to the pathogen, look for the pathogen itself. It makes perfect sense and is the approach the Infectious Disease Society of America prefers for infectious diseases.

But for Borrelia burgdorferi, the bacteria that causes Lyme Disease, direct detection is more challenging than it sounds. Borrelia hide in tissues and are difficult to capture in a blood sample. The bacterial count has been reported to be as low as 0.1 per mL of blood. This is 3-4 orders of magnitude below the detection limits of conventional PCR.

At this concentration, the probability of detecting Borrelia in a blood sample with conventional PCR is about the same as the lifetime chance of getting struck by lightning. Read that again.

But science provides solutions. I read the research and mapped the Lyme diagnostic space and was encouraged. A small company called Galaxy Diagnostics had commercialized the first antigen test for Lyme using a urine sample. Borrelia colonize in the bladder and release proteins unique to the pathogen.

Using sample enrichment techniques, the Lyme Borrelia Nanotrap® Antigen Test can detect this protein and confirm infection in all stages of the disease, including in those who have been treated. Published results show 100% sensitivity in early-stage patients with the characteristic Lyme rash, a dramatic improvement over the status quo.

I was so impressed with Galaxy Diagnostics’ technology that I decided to join the company, which had best-in-class science and novel assays that were driving clinical discovery. They needed help scaling the business and bringing their solutions to a broader audience—precisely what I love to do. I joined as the Chief Business Officer and recently transitioned to CEO.

In the past year, we’ve been working to raise the funds needed to take Galaxy Diagnostics’ technology to the next level. Not only do we need a new diagnostic standard of care for Lyme disease, but there is also a long list of co-infections, such as Bartonella and Babesia, that are equally difficult to diagnose. Galaxy Diagnostics’ mission is to provide doctors with a comprehensive toolkit to diagnose these infections accurately. Patients like Russ deserve an answer, and Galaxy Diagnostics is working to make that happen.

Bell, N., & Brown, G. (2022, June 1). It started with a tick bite. How I lost my husband to undiagnosed Lyme disease. Today. https://www.today.com/health/essay/tick-bite-husband-undiagnosed-lyme-disease-rcna31268

Waddell, L. A., et al. (2016). The accuracy of diagnostic tests for Lyme disease in humans, a systematic review and meta-analysis of North American research. PLoS ONE, 11(12), Article e0168613. https://doi.org/10.1371/journal.pone.0168613

Wormser, G. P., et al. (2001). Yield of large-volume blood cultures in patients with early Lyme disease. Journal of Infectious Diseases, 184(8), 1070-1072. https://doi.org/10.1086/323424

Galaxy Diagnostics. (n.d.). Lyme Borrelia Nanotrap antigen test. https://www.galaxydx.com/nanotrap-urine-test-for-lyme-disease/

Magni, R., et al. (2015). Application of Nanotrap technology for high sensitivity measurement of urinary outer surface protein A carboxyl-terminus domain in early stage Lyme borreliosis. Journal of Translational Medicine, 13, Article 346. https://doi.org/10.1186/s12967-015-0701-z

Cheslock, M. A., & Embers, M. E. (2019). Human bartonellosis: An underappreciated public health problem? Tropical Medicine and Infectious Diseases, 4(2), Article 69. https://doi.org/10.3390/tropicalmed4020069

Peake, T., & Breitschwerdt, E. (2024, July 16). Bartonella and Babesia co-infection detected in patients with chronic illness. https://news.ncsu.edu/2024/07/bartonella-and-babesia-co-infection-detected-in-patients-with-chronic-illness/