Laboratory licensing opportunities

Background

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.

The opportunity

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.

The MELISA® test

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.

Considerations

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.

Lyme disease

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. For more information see our Lyme disease page.

Future applications

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.

Interested? Please email us at [email protected] and we can arrange a time to talk further and give you more detail.

 

 

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