More effective diagnosis of Lyme disease than before

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The latest innovative laboratory diagnostic procedure developed by Hungarians, DualDur, has entered the market, which identifies the cause of tick-borne Lyme disease at any time of the disease, even within a week after the bite – the developer Lyme Diagnostics Kft. Told MTI .

Lyme disease affects 10,000 people a year in Hungary, and every second to third tick in the country is infected. “If the disease is not recognized in the initial stages and remains untreated for an extended period of time, myocarditis, arrhythmias, neuritis, or even paralysis can develop later,” chief physician Erik Kolbenheyer said in a statement.

The innovative development of the Hungarian Lyme Diagnostics Kft. Can be a solution for diagnosing the disease, which With a unique method across Europe, it can detect the pathogen early, even within a few days of being bitten. One reason for this is that the new method is based on the detection of bacteria rather than the immune response, which in many patients develops late or not at all. This method was developed by Béla Bózsik, chief physician, scientific director of Lyme Diagnostics Kft., Based on dark-field microscopy, at the National Institute of Public Health.

Lyme disease can be tested in the laboratory with direct and indirect tests: indirect tests show the body’s immune response, and direct tests show the pathogen itself or part of it. In an average disease, the traditional methods are culture or antibody testing, but these are not successful in Lyme disease, as they are unlikely to be cultured for months, and in most cases the immune response is not measurable or develops. – said András Pál Bózsik, managing director of Lyme Diagnostics Kft. He added that DualDur not only detects the pathogen, but also uses statistical analyzes and artificial intelligence to assess its effects on the body – symptomatic or asymptomatic – thus surpassing direct methods. The amount of information provided by the system significantly exceeds the information content of previous analytical procedures.

During the project, Lyme Diagnostics Kft. Carried out the largest Lyme diagnostic clinical research in Europe in 8 examination sites in 6 Central European countries, involving 400 subjects. The investigation confirmed that the sensitivity of the test is 60 percent higher than the most commonly used Lyme test from a specialist provider. DualDur can identify 96 percent of patients, so it can be used with great certainty as a screening test in clinics, complementing current procedures.

Asked about MTI, Lyme Diagnostics Ltd. has been dealing with it since 2012 preparing for the launch of the DualDur cell technology fluid and method, planning and conducting clinical trials and obtaining approvals.

Ltd. performs tests primarily through laboratory partners, and has four globally unique, self-developed tests that have recently been introduced: the DualDur automated test is the leading product to detect Borrelia infection that causes Lyme disease. Thanks to automated systems, the capacities can mean a minimum of 20,000 tests per machine per year, and there are currently two machines available.

In addition, the company has test packages that are available in other laboratories. These were selected from the services of their lab partners and arranged into individual packages to reveal additional possible signs of tick-borne infections to the diagnosing physician.

Currently, they can only provide paid tests, and social security funding can be a multi-year process.

Last year, Lyme Diagnostics Kft. Was still developing and licensing the technology, so its commercial turnover was minimal, HUF 730,000. The service was launched in May this year, and most of the sales revenue is generated by the laboratory partners. Lyme Diagnostics Kft. Realizes sales revenue from its partners after renting the tools and software, providing the consumables and making the know-how available. The company employs 14 people.

The total development required an investment of € 4 million, of which € 3.5 million was direct support from the European Union.

The company still spends all of its sales revenue on improving the DualDur method and developing additional methods, and is planning joint research with several international development partners in the United States, France, Belgium, Italy, Austria and Hungary.


Source: Patika Magazin Online by www.patikamagazin.hu.

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