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  • Title: Laboratory licensing opportunities
  • Subtitle: Melisa
  • List item:
    • List title: Background, List text:

      The medical device market is growing rapidly each year and is expected to reach $30.4 billion by 2025; the dental implant market is predicted to grow to $8 billion during this period. Growth is driven by an ageing population and increasing cardiovascular and neurological diseases. There are international calls for stricter regulations and for more research into device failure. One of the factors contributing to device failure is metal hypersensitivity.

    • List title: The opportunity, List text:

      MELISA is seeking to expand its network of laboratories to make the testing more accessible to healthcare practitioners worldwide. As the number of medical devices implanted grows there is concomitant growth in demand for metal hypersensitivity testing. We are looking for laboratory partners, particularly in North America, where demand is highest for testing.

    • List title: The MELISA® test, List text:

      MELISA® (MEmory Lymphocyte Immuno-Stimulation Assay) is a modified, optimised and clinically validated version of lymphocyte transformation testing (LTT). The MELISA test provides important information for patients suffering from unexplained symptoms after surgery and is also used prior to surgery in patients reporting previous metal sensitivity. Details can be found in our published articles.

    • List title: Considerations, List text:

      Blood must arrive at the laboratory within 48 hours after the blood draw. Lymphocytes are isolated and put into cultures with  against metal allergens, blood is incubated for five days and the lymphocyte reaction is measured by two separate technologies: the uptake of radioisotope by dividing lymphocytes and by microscopy.

      A license is needed to handle low-level radioactivity and in the US, the laboratory must be CLIA registered to perform high complexity testing, the test is offered as a Lab Developed Test (LDT) in the US.

    • List title: Lyme disease, List text:

      MELISA has also been developed to diagnose active infections of Lyme Borreliosis, which appears to be a more accurate test for diagnosing active Lyme disease than standard tests (Western Blot, PCR) particularly in symptomatic patients with serologically ambiguous results.

    • List title: Future applications, List text:

      MELISA is mainly used to determine metal allergy, but the test is also developed for other substances. Some laboratories routinely test for allergy to gluten, candida and moulds. We are extremely interested in developing the test for other substances such as gadolinium, PEEK, pesticides and food allergens.
  • Additional info bottom: Interested? Please email us at info@melisa.org and we can arrange a time to talk further and give you more detail.

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Melisa

Team

Linda Nelson

Managing Director
Linda Nelson has been the Managing Director of MELISA since 2005. After witnessing how MELISA testing has helped patients recover from chronic illnesses, she has made it her aim to raise awareness of how metals can induce serious health problems in sensitive individuals. She does this by: encouraging and enabling research, working with licensed MELISA laboratories to develop new applications for testing and by organising international conferences.

Olaf Beckord

Dipl. Chem. Ing (GER)

Olaf Beckord trained as an Analytical Chemist and has headed up several German laboratories. For 12 years, Olaf was the Technical Director of InVitaLab, Neuss, working with MELISA testing. Together with Prof Vera Stejskal, he has developed testing for new substances using the MELISA protocol.

Olaf continues to provide medical and scientific support as well as participating in conferences and training new laboratories to perform MELISA testing under license.

Dr Birgitta Brunes

MD

Dr Brunes is a general practitioner who specializes in the treatment of multiple sclerosis. She was herself diagnosed with MS, but is now cured as showed by MRI. She has published a book on her experience: “From Multiple Sclerosis to Better Health”.

brunes.se

Mrs Rebecca Dutton

Mrs Dutton’s personal experience with mercury-induced ill-health encouraged her to collate scientific evidence on the effect of mercury on health. At the same time, she set up a patient support group to offer advice and guidance to others with similar symptoms. She is particularly interested in the role of mercury in the development of scoliosis.

understandingscoliosis.org

Dr Jose Mendonça Caridad

MD, DDS
Dr Mendonça Caridad is a doctor, dentist and oral and maxillofacial surgeon. Previously a Clinical and Research Fellow in Oral and Maxillofacial Surgery at the UCLA School of Dentistry, he is now working at the Polusa hospital in Lugo, Spain. He uses autologous stem cells for reconstruction and rehabilitation of the oral cavity. He is the co-author of the first clinical paper on stem cell therapies in advanced disease in the head and neck region and of one of the first clinical papers on stem cells (published in Journal of Plastic and Reconstructive Surgery in 2010). He also works as a volunteering surgeon in Africa and helps rebuild the faces of children with deformities.

cirujanosdelmundo.com

Prof. Vera Stejskal

(1944-2017)

Associate Professor of Immunology
Prof. Stejskal passed away in 2017. She was the inventor of the MELISA test, formerly head of Immunotoxicology at Astra Pharmaceuticals (now known as AstraZeneca), where she played a key role developing Losec, Astra’s multi-billion-dollar stomach ulcer drug. She left Astra in 1996 to concentrate full-time on MELISA and became Associate Professor of Immunology at the University of Stockholm. She has written numerous articles on metal allergy and gave frequent lectures.

Melisa

Background

The MELISA organisation is dedicated to the science of metal hypersensitivity and improving its diagnosis when treating chronic diseases such as chronic fatigue syndrome, multiple sclerosis or other autoimmune and allergic diseases.

The MELISA test was developed to aid clinicians and patients in the diagnosis of metal hypersensitivity. It is a clinically validated blood test which measures metal hypersensitivity to multiple metals from a single sample. It was originally developed for the diagnosis of occupational allergies at Astra Pharmaceuticals (now AstraZeneca).

The MELISA test, a modification of the LTT test, started to take shape when Dr Vera Stejskal, a toxicologist at Astra Pharmaceuticals in Södertälje, Sweden, was asked to develop a test for the diagnosis of drug allergy among workers in their pharmaceutical factories. In 1990, a colleague of Dr Stejskal, dermatologist Dr Margit Forsbeck, expressed a wish to try the test on patients who claimed that their symptoms were caused by their amalgam fillings. At that time, many patients came to Dr Forsbeck with oral problems – burning, itching and lichenoid reactions – and claimed that they suffered from “oral galvanism” or “amalgam poisoning”.
The problem was that patch testing was not very reliable for testing metals on the skin, as some metals are toxic substances. If a metal causes irritation on the skin, it is difficult to differentiate between a toxic and an allergic reaction. The dermatologist was concerned to know if mercury allergy really existed and wanted to prove or disprove this. Perhaps MELISA could do the job?

Astra, a pharmaceutical rather than a diagnostic company, had no interest in developing the MELISA test and so, shortly afterwards, the MELISA organisation was founded to promote research into metal hypersensitivity and its implications in contributing to the development of chronic diseases such as multiple sclerosis and chronic fatigue syndrome.

The MELISA test was then optimised and standardised and finally validated for testing multiple metals. Today, MELISA is performed under license by certified laboratories worldwide. To date, the MELISA test has helped hundreds of patients to lead healthier lives.

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