A highly-sensitive low-cost process may be the golden fleece for those who are sick and suspect Lyme but can’t get a positive test due to the faulty Lyme testing processes.

“Lab-on-a-Chip” is a new system that appears to be a wonderful break through for chronic Lyme disease diagnosis.

HILYSENS will develop a low-cost biomedical kit for testing of acute and chronic infectious diseases based on a disposable microfluidics chip integrating all the analysis functions and mass-produced using nanoimprint technology.

The project will focus on developing such a tool to fill the existing gap in Lyme disease diagnosis.

As you know, Lyme disease is caused by the pleomorphic bacteria Borrelia burgdoferi, transmitted to humans after the bite of an infected tick.

There are conservatively 85,000 new disease cases in Europe every year, and even more here in the US.  Some believe its incidence increasing due to the climate change, however it seems more likely to me that the extreme growth is due to doctors refusing to diagnose the disease AND the many methods for catching the disease.

The CDC states that a tick must remain on its host for 24-48 hours for you to contract Lyme.  This is clearly NOT the case.

A vetinarian I know locally here in Maine, was hit by a flying needle from a dog he was treating for Lyme.  The needle was in his arm for perhaps 2 – 4 SECONDS and he had a perfect bulls eye rash and flu only 10 days later, and the rash was in the exact place the needle had penetrated his arm.

Biting flies, mosquitoes, kissing, sexual intercourse – ANY exchange of bodily fluids or infected insect bite can cause Lyme disease.

Cystic (wall-deficient) forms of pleomorphic bacteria present an altered protein expression pattern as compared to the parental forms which makes them undetectable with current commercial methods. Moreover, cyst forms are present at low concentrations in the body during the dormant phase thus a highly sensitive system is required for their detection. Such forms can remain long after the acute phase of infection and cause further chronic diseases.

Many people are infected and then the body manages to keep the illness at bay for months or years before the bacteria takes over.  This long dormancy is reminiscent of its cousin syphilis.  So, when someone is suffering with Lyme years after the initial contraction, doctors are puzzled (and lately with such heat on the medical community to circle the wagons and insist on Lyme being easily treated…) and the suffering patients are subjected to test after test – the current blood test misses between 50 and 70% not a very helpful tool.

Basically, the current diagnostic tools for Lyme disease just will sometimes detect recent infections because the body develops and releases antibodies but more often- especially with chronic Lyme disease cases – the cystic bacterial form, are labour-intensive and lack the required sensitivity leading to false negative results and ultimately to patients’ misdiagnosis and mismanagement.

The core of the project offers a highly-sensitive “lab-on-a-chip” device built using a nanoimprinting technology to enable much faster production at minimal costs. An optical reader will also be developed to enable user-friendly readout and interpretation of results. The resulting tool can easily be adapted to a wider infectious disease market for other pleomorphic bacteria such as chronic Lyme disease and bacteria involved in other serious diseases.

To produce such a diagnostic tool, a synergistic effort by developers of molecular assays and miniaturisation and microfluidics manufacture experts is required. European industries in both sectors envisage a great business potential for the HILYSENS system in constantly increasing markets such as molecular diagnostics – especially for chronic Lyme disease.