Lyme disease, or Lyme borreliosis, is caused by the Borrelia bacteria. This infectious disease is typically transferred by a bite from an infected Ixodes tick.
In the Netherlands alone an estimated 1.5 million tick bites occur annually, with more than 25,000 infections as a result. In the US, the incidence of Lyme disease is estimated to be 300,000 cases per year.
The most evident early symptom of Lyme Disease is an expanding area of redness (an erithema migrans). Typically only half of the infected people develop this symptom. Other complaints are headache, fever, tiredness, muscle ache and neurological or reumatoid symptoms.
Early diagnostics are important. Timely diagnosed Borrelia infection can be treated with common oral antibiotics, such as doxycycline. When the disease remains unnoticed, it may lead to parts of the face becoming paralyzed, joint pains, heart palpitations and other complaints. To prevent such complaints Innatoss Laboratories is working on a test for early diagnostics.
An extensive review on diagnosis and treatment of Lyme Disease was recently published in the Journal of Autoimmunity (Borchers et al. 2014). This review outlines the complications in diagnosing Lyme disease and the many differences between Lyme Disease in the USA and in Europe.
In the Netherlands, a CBO guideline on Lyme disease was published in 2013. The guideline does not provide a solution for diagnosis of Lyme in an early stage, with the exception of a clinical diagnosis based on development of an Erythema migrans.
Without a strictly defined EM, an a priori chance estimation of active Lyme disease should be used to decide who should be tested serologically (measurement of antibodies) and who should not. For those that are not tested a ‘wait and see’ policy is followed after a tick bite. In the tested group, a positive screening test is followed by an immunoblot. Results are only to be used when both are positive. This two-tier strategy leads to very high specificity but limited sensitivity in the early stage. At Innatoss we believe that the latter leads to an unequivalently large number of false-negatives (having the disease, but not being diagnozed as such) compared to the number of false-positives one tries to prevent.
New type of test
Innatoss Laboratories is working on a new test based on the cellular immmune response. This sheds a new light on the matter in addition to the usual antibody testing.
The cellular test has potential to facilitate treatment decisions within the first 4 weeks after a tick bite. And as such assist in the prevention of health problems that are associated with chronic disease.
Early diagnosed Lyme disease can be treated with high cure percentages. This is evident when taking a look at the cure rate of patients that were treated based on the typical expanding red circle. Most were cured by a short period of using antibiotics, e.g. doxycycline. Unfortunately, the red skin symptom shows up in about 50% of cases, mostly within 4 weeks from tick bite.
Finding the other 50% of Lyme disease cases within 4 weeks after the tick bite, that is the challenge we face.
Based on a patent that we’ve licensed from a partner in the US, extensive literature review and in-house testing, we have outlined a range of biomarkers that may assist in overcoming this challenge. From our work at Q fever, we know that these markers can be very telling on infections.
The Proof of Concept study on biomarkers for early diagnosis of Lyme disease is currently being performed. After this study we hope to have compelling evidence of which biomarkers are most telling. We expect to launch our first cellular Lyme test in spring 2017, at start for Research Use Only.
After Proof of Concept more validation work will be performed, most likely in a European setting. Think of process validation, inter-laboratory comparison, cross reactivity studies, etc.
If you would like to contribute to these new developments, please let us know. Send us an email here. We look forward to share our ideas, for example during one of the upcoming congresses.
We have listed some literature that supports us on the road of discovery. Hopefully you will find these interesting. Please let us know your honest opinion.